Compositions comprising antineoplastons and methods of treating lung cancer

Abstract

Disclosed herein are compositions comprising one or more antineoplastons and using those compositions in methods of treating lung cancer, prolonging the survival of a subject, and preventing and / or decreasing metastasis of lung cancer.

Description

COMPOSITIONS COMPRISING ANTINEOPLASTONS AND METHODS OF TREATING LUNG CANCERI. CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 522,136 filed 21 June 2023, which is incorporated by reference herein in its entirety.II. BACKGROUND

[0002] Cancer is daunting in the breadth and scope of its diversity, spanning genetics, cell and tissue biology, pathology, and response to therapy. Lung cancer is by far the leading cause of cancer death in the US. accounting for about 1 in 5 of all cancer deaths. Each year, more people die of lung cancer than of colon, breast, and prostate cancers combined. In 2023, the number of new cases of lung cancer is projected to be over 238,000 while the number of deaths due to lung cancer is projected to be more than 127,000. Despite advances in care, there remains an unmet medical need for developing methods of effectively treating subjects having lung cancer or metastatic lung cancer.III. BRIEF SUMMARY

[0003] Disclosed herein are compositions comprising one or more antineoplastons.

[0004] Disclosed herein is a pharmaceutical formulation comprising one or more antineoplastons and one or more pharmaceutically acceptable carriers.

[0005] Disclosed herein is a kit comprising one or more disclosed antineoplastons and one or more targeted therapies.

[0006] Disclosed herein is a kit comprising one or more disclosed antineoplastons and one or more targeted therapies, wherein the antineoplastons and the targeted therapies are used to treat a subject having one or more cancers.

[0007] Disclosed herein is a kit comprising one or more disclosed antineoplastons and one or more targeted therapies, wherein the antineoplastons and the targeted therapies are used to treat a subject having lung cancer or metastatic lung cancer.

[0008] Disclosed herein is a kit comprising a disclosed pharmaceutical formulation comprising one or more antineoplastons and one or more targeted therapies.

[0009] Disclosed herein is a kit comprising a disclosed pharmaceutical formulation comprising one or more antineoplastons and one or more targeted therapies, wherein the pharmaceutical formulation comprising one or more antineoplastons and the targeted therapies are used to treat a subject having one or more cancers.

[0010] Disclosed herein is a kit comprising a disclosed antineoplastons and one or more targeted therapies, wherein the pharmaceutical formulation comprising one or more antineoplastons and the targeted therapies are used to treat a subject having lung cancer or metastatic lung cancer.

[0011] Disclosed herein is a kit comprising one or more disclosed antineoplastons and one or more targeted therapies for one or more treatment cycles.

[0012] Disclosed herein is a kit comprising one or more disclosed antineoplastons and one or more targeted therapies, wherein the antineoplastons and the targeted therapies are used to treat a subject having one or more cancers for one or more treatment cycles.

[0013] Disclosed herein is a kit comprising one or more disclosed antineoplastons and one or more targeted therapies, wherein the antineoplastons and the targeted therapies are used to treat a subject having lung cancer or metastatic lung cancer for one or more treatment cycles.

[0014] Disclosed herein is a kit comprising a disclosed pharmaceutical formulation comprising one or more antineoplastons and one or more targeted therapies for one or more treatment cycles.

[0015] Disclosed herein is a kit comprising a disclosed pharmaceutical formulation comprising one or more antineoplastons and one or more targeted therapies, wherein the pharmaceutical formulation comprising one or more antineoplastons and the targeted therapies are used to treat a subject having one or more cancers for one or more treatment cycles.

[0016] Disclosed herein is a kit comprising a disclosed antineoplastons and one or more targeted therapies, wherein the pharmaceutical formulation comprising one or more antineoplastons and the targeted therapies are used to treat a subject having lung cancer or metastatic lung cancer for one or more treatment cycles.

[0017] Disclosed herein is a method for treating lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising a therapeutically effective amount of one or more antineoplastons or a pharmaceutical formulation thereof, and a therapeutically effective amount of one or more targeted therapies.

[0018] Disclosed herein is a method for treating lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising precision cancer treatment comprising a therapeutically effective amount of one or more antineoplastons, and a therapeutically effective amount of one or more targeted therapies.

[0019] Disclosed herein is a method for treating lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising a therapeuticallyeffective amount of AS2-1 and / or A10, and a therapeutically effective amount of one or more targeted therapies.

[0020] Disclosed herein is a method for treating lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising precision cancer treatment comprising a therapeutically effective amount of AS2-1 and / or A10, and a therapeutically effective amount of one or more targeted therapies.

[0021] Disclosed herein is a method for treating lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising a therapeutically effective amount of AS2-1 and / or A10, and a therapeutically effective amount of one or more targeted therapies, wherein the one or more targeted therapies comprise abemaciclib, ado- trastuzumab emtansine, afatinib, alectinib, alemtuzumab, alpelisib, atezolizumab. avelumab, axitinib, bevacizumab, binimetinib, blinatumomab, bosutinib, brentuximab, brigatinib, cabozantinib, carfilzomib, cemiplimab, ceritinib, cetuximab, gilteritinib, cobimetinib, copanlisib, crizotinib, dabrafenib, dacomitinib, daratumumab, dasatinib, denosumab, dinutuximab. durvalumab, duvelisib, elotuzumab, encorafenib, entrectinib. erdafitinib, erlotinib, fam-trastuzumab deruxtecan-nxki, gefitinib. gemtuzumab, ibritumomab tiuxetan. ibrutinib, imatinib, inotuzumab, ipilumumab, ivosidenib, lapatinib, larotrectinib, lenvatinib, lorlatinib, margetuximab-cmkb, necitumumab, neratinib, nilotinib, niraparib, nivolumab, obinutuzumab, ofatumumab, olaparib, olaratumab, osimertinib. palbociclib, panitumumab, pazopanib. pembrolizumab. pertuzumab. ponatinib, pralsetinib. ramucirumab. regorafenib, ribociclib, rituximab, rucaparib, sorafenib, sunitinib, talazoparib, tivozanib, tositumomab, trametinib, trastuzumab, tucatinib, vandetanib, vemurafenib, vismodegib, or any combination thereof.

[0022] Disclosed herein is a method for treating lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising precision cancer treatment comprising a therapeutically effective amount of one or more antineoplastons, and a therapeutically effective amount of one or more targeted therapies, wherein the antineoplastons comprise AS2-1 and / or A10 and wherein the targeted therapies comprise abemaciclib. ado- trastuzumab emtansine, afatinib, alectinib, alemtuzumab, alpelisib, atezolizumab. avelumab. axitinib, bevacizumab, binimetinib, blinatumomab, bosutinib, brentuximab, brigatinib, cabozantinib, carfilzomib, cemiplimab, ceritinib, cetuximab, gilteritinib, cobimetinib, copanlisib, crizotinib, dabrafenib, dacomitinib, daratumumab, dasatinib, denosumab, dinutuximab. durvalumab, duvelisib, elotuzumab. encorafenib, entrectinib. erdafitinib, erlotinib, fam-trastuzumab deruxtecan-nxki, gefitinib, gemtuzumab, ibritumomab tiuxetan,ibrutinib, imatinib, inotuzumab, ipilumumab, ivosidenib, lapatinib, larotrectinib, Lenvatinib, lorlatinib, margetuximab-cmkb. necitumumab, neratinib. nilotinib, niraparib, nivolumab, obinutuzumab, ofatumumab, olapanb. olaratumab, osimertinib, palbociclib, panitumumab, pazopanib, pembrolizumab, pertuzumab, ponatinib, pralsetinib, ramucirumab, regorafenib, ribociclib, rituximab, rucaparib, sorafenib, sunitinib, talazoparib, tivozanib, tositumomab, trametinib, trastuzumab, tucatinib. vandetanib, vemurafenib, vismodegib, or any combination thereof.

[0023] Disclosed herein is a method for treating lung cancer, the method comprising administering to a subject in need thereof a therapeutically effective amount of one or more antineoplastons or a pharmaceutical formulation, wherein the subject has already received or is actively receiving one or more targeted therapies.

[0024] Disclosed herein is a method for treating lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising precision cancer treatment comprising a therapeutically effective amount of one or more antineoplastons, wherein the subject has already received or is actively receiving one or more targeted therapies.

[0025] Disclosed herein is a method for treating lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising a therapeutically effective amount of AS2-1 and / or A10, wherein the subject has already received or is actively receiving one or more targeted therapies.

[0026] Disclosed herein is a method for treating lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising precision cancer treatment comprising a therapeutically effective amount of AS2-1 and / or A10, wherein the subject has already received or is actively receiving one or more targeted therapies.

[0027] Disclosed herein is a method for treating lung cancer, the method comprising administering to a subject in need thereof a therapeutically effective amount of AS2-1 and / or A10, wherein the subject has already received or is actively receiving one or more targeted therapies and wherein the one or more targeted therapies comprise abemaciclib, ado- trastuzumab emtansine, afatinib, alectinib, alemtuzumab, alpelisib, atezolizumab, avelumab, axitinib, bevacizumab, binimetinib. blinatumomab, bosutinib, brentuximab, brigatinib. cabozantinib, carfilzomib, cemiplimab, ceritinib, cetuximab, gilteritinib, cobimetinib, copanlisib, crizotinib, dabrafenib, dacomitinib, daratumumab, dasatinib, denosumab, dinutuximab. dun alumab. duvelisib, elotuzumab, encorafenib, entrectinib. erdafitinib, erlotinib, fam-trastuzumab deruxtecan-nxki, gefitinib, gemtuzumab, ibritumomab tiuxetan, ibrutinib, imatinib, inotuzumab, ipilumumab, ivosidenib, lapatinib, larotrectinib, Lenvatinib,lorlatinib, margetuximab-cmkb. necitumumab, neratinib, nilotinib, niraparib, nivolumab, obinutuzumab. ofatumumab, olaparib, olaratumab, osimertinib. palbociclib, panitumumab, pazopanib, pembrolizumab, pertuzumab, ponatinib, pralsetinib, ramucirumab, regorafenib, ribociclib, rituximab, rucaparib, sorafenib, sunitinib, talazoparib, tivozanib, tositumomab, trametinib, trastuzumab, tucatinib, vandetanib, vemurafenib, vismodegib, or any combination thereof.

[0028] Disclosed herein is a method for treating lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising precision cancer treatment comprising a therapeutically effective amount of one or more antineoplastons, wherein the antineoplastons comprise AS2-1 and / or A10, wherein the subject has already received or is actively receiving one or more targeted therapies and wherein the targeted therapies comprise abemaciclib, ado-trastuzumab emtansine, afatinib, alectinib, alemtuzumab, alpelisib, atezolizumab, avelumab, axitinib, bevacizumab, binimetinib, blinatumomab, bosutinib, brentuximab, brigatinib, cabozantinib, carfdzomib, cemiplimab, ceritinib, cetuximab, gilteritinib, cobimetinib, copanlisib, crizotinib. dabrafenib. dacomitinib, daratumumab, dasatinib, denosumab, dinutuximab, durvalumab, duvehsib, elotuzumab. encorafenib, entrectinib, erdafitinib, erlotinib, fam-trastuzumab deruxtecan-nxki, gefitinib, gemtuzumab, ibritumomab tiuxctan. ibrutinib, imatinib, inotuzumab, ipilumumab, ivosidenib, lapatinib. larotrectinib, Lenvatinib, lorlatinib. margetuximab-cmkb, necitumumab, neratinib, nilotinib. niraparib, nivolumab, obinutuzumab, ofatumumab, olaparib, olaratumab, osimertinib, palbociclib, panitumumab, pazopanib, pembrolizumab, pertuzumab, ponatinib, pralsetinib, ramucirumab, regorafenib, ribociclib, rituximab, rucaparib, sorafenib, sunitinib, talazoparib, tivozanib, tositumomab, trametinib, trastuzumab, tucatinib, vandetanib, vemurafenib. vismodegib, or any combination thereof.

[0029] Disclosed herein is a method for reducing metastases in a subject having lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising a therapeutically effective amount of one or more antineoplastons or a pharmaceutical formulation thereof, and a therapeutically effective amount of one or more targeted therapies, wherein the subject demonstrates a tumor response and / or molecular response to treatment regimen, and wherein metastases are prevented and / or decreased.

[0030] Disclosed herein is a method for reducing metastases in a subject having lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising precision cancer treatment comprising a therapeutically effective amount of one or more antineoplastons, and a therapeutically effective amount of one or more targeted therapies,wherein the subject demonstrates a tumor response and / or molecular response to treatment regimen, and wherein metastases are prevented and / or decreased.

[0031] Disclosed herein is a method for reducing metastases in a subject having lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising a therapeutically effective amount of AS2-1 and / or A10, and a therapeutically effective amount of one or more targeted therapies, wherein the subject demonstrates a tumor response and / or molecular response to treatment regimen, and wherein metastases are prevented and / or decreased.

[0032] Disclosed herein is a method for reducing metastases in a subject having lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising precision cancer treatment comprising a therapeutically effective amount of AS2- 1 and / or Al 0, and a therapeutically effective amount of one or more targeted therapies, wherein the subject demonstrates a tumor response and / or molecular response to treatment regimen, and wherein metastases are prevented and / or decreased.

[0033] Disclosed herein is a method for reducing metastases in a subject having lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising a therapeutically effective amount of AS2-1 and / or A10, and a therapeutically effective amount of one or more targeted therapies, wherein the one or more targeted therapies comprise abemaciclib, ado-trastuzumab emtansine, afatinib, alectinib, alemtuzumab, alpelisib, atezolizumab, avelumab, axitinib. bevacizumab. binimetinib. blinatumomab, bosutinib, brentuximab, brigatinib, cabozantinib, carfilzomib, cemiplimab, ceritinib, cetuximab, gilteritinib, cobimetinib, copanlisib, crizotinib, dabrafenib, dacomitinib, daratumumab, dasatinib, denosumab, dinutuximab, durvalumab, duvelisib, elotuzumab, encorafenib, entrectinib. erdafitinib, erlotinib, fam-trastuzumab deruxtecan-nxki. gefitinib, gemtuzumab, ibritumomab tiuxetan, ibrutinib, imatmib, inotuzumab, ipilumumab, ivosidenib, lapatinib, larotrectinib, Lenvatinib, lorlatinib, margetuximab-cmkb, necitumumab, neratinib, nilotinib, niraparib, nivolumab, obinutuzumab, ofatumumab, olaparib, olaratumab, osimertinib, palbociclib, panitumumab, pazopanib, pembrolizumab, pertuzumab, ponatinib, pralsetinib, ramucirumab, regorafenib, ribociclib. rituximab, rucaparib, sorafenib, sunitinib, talazoparib. tivozanib, tositumomab, trametinib, trastuzumab, tucatinib, vandetanib, vemurafenib, vismodegib, or any combination thereof, wherein the subject demonstrates a tumor response and / or molecular response to treatment regimen, and wherein metastases are prevented and / or decreased.

[0034] Disclosed herein is a method for reducing metastases in a subject having lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising precision cancer treatment comprising a therapeutically effective amount of one or more antineoplastons, and a therapeutically effective amount of one or more targeted therapies, wherein the antineoplastons comprise AS2-1 and / or A10 and wherein the targeted therapies comprise abemaciclib, ado-trastuzumab emtansine, afatinib, alectinib, alemtuzumab, alpelisib, atezolizumab, avelumab, axitinib. bevacizumab. binimetinib. blinatumomab, bosutinib. brentuximab, brigatinib, cabozantinib, carfilzomib, cemiplimab, ceritinib, cetuximab, gilteritinib, cobimetinib, copanlisib, crizotinib, dabrafenib, dacomitinib, daratumumab, dasatinib, denosumab, dinutuximab, durvalumab, duvelisib, elotuzumab, encorafenib, entrectinib. erdafitinib, erlotinib, fam-trastuzumab deruxtecan-nxki. gefitinib, gemtuzumab, ibritumomab tiuxetan, ibrutinib, imatinib, inotuzumab, ipilumumab, ivosidenib, lapatinib, larotrectinib, Lenvatinib, lorlatinib, margetuximab-cmkb, necitumumab, neratinib, nilotinib, niraparib, nivolumab, obinutuzumab, ofatumumab, olaparib, olaratumab, osimertinib, palbociclib, panitumumab, pazopanib, pembrolizumab, pertuzumab, ponatinib, pralsetinib, ramucirumab, regorafenib, ribociclib. rituximab, rucaparib, sorafenib, sunitinib, talazoparib. tivozanib, tositumomab, trametinib, trastuzumab, tucatinib, vandetanib, vemurafenib, vismodegib, or any combination thereof, wherein the subject demonstrates a tumor response and / or molecular response to treatment regimen, and wherein metastases are prevented and / or decreased.

[0035] Disclosed herein is a method for reducing metastases in a subject having lung cancer, the method comprising administering to a subject in need thereof a therapeutically effective amount of one or more antineoplastons or a pharmaceutical formulation, wherein the subject has already received or is actively receiving one or more targeted therapies, wherein the subject demonstrates a tumor response and / or molecular response, and wherein metastases are prevented and / or decreased.

[0036] Disclosed herein is a method for reducing metastases in a subject having lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising precision cancer treatment comprising a therapeutically effective amount of one or more antineoplastons, wherein the subject has already received or is actively receiving one or more targeted therapies, wherein the subject demonstrates a tumor response and / or molecular response to treatment regimen, and wherein metastases are prevented and / or decreased.

[0037] Disclosed herein is a method for reducing metastases in a subject having lung cancer, the method comprising administering to a subject in need thereof a treatment regimencomprising a therapeutically effective amount of AS2-1 and / or A10, wherein the subject has already received or is actively receiving one or more targeted therapies, wherein the subject demonstrates a tumor response and / or molecular response to treatment regimen, and wherein metastases are prevented and / or decreased.

[0038] Disclosed herein is a method for reducing metastases in a subject having lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising precision cancer treatment comprising a therapeutically effective amount of AS2- 1 and / or A10, wherein the subject has already received or is actively receiving one or more targeted therapies, wherein the subject demonstrates a tumor response and / or molecular response to treatment regimen, and wherein metastases are prevented and / or decreased.

[0039] Disclosed herein is a method for treating lung cancer, the method comprising administering to a subject in need thereof a therapeutically effective amount of AS2-1 and / or A10, wherein the subject has already received or is actively receiving one or more targeted therapies and wherein the one or more targeted therapies comprise abemaciclib, ado- trastuzumab emtansine, afatinib, alectinib, alemtuzumab, alpelisib, atezolizumab. avelumab, axitinib, bevacizumab, binimetinib. blinatumomab, bosutinib, brentuximab, brigatinib. cabozantinib, carfdzomib, cemiplimab, ceritinib, cetuximab, gilteritinib, cobimetinib, copanlisib, crizotinib, dabrafenib, dacomitinib, daratumumab, dasatinib, denosumab, dinutuximab. durvalumab, duvelisib, elotuzumab, encorafenib, entrectinib. erdafitinib, erlotinib, fam-trastuzumab deruxtecan-nxki, gefitinib. gemtuzumab, ibritumomab tiuxetan, ibrutinib, imatinib, inotuzumab, ipilumumab, ivosidenib, lapatinib, larotrectinib, Lenvatinib, lorlatinib, margetuximab-cmkb, necitumumab, neratinib, nilotinib, niraparib, nivolumab, obinutuzumab, ofatumumab, olaparib, olaratumab, osimertinib. palbociclib, panitumumab, pazopanib, pembrolizumab. pertuzumab. ponatinib. ramucirumab, regorafenib, ribociclib, rituximab, rucaparib, sorafenib, sunitinib, talazoparib, tivozanib, tositumomab, trametinib, trastuzumab, tucatinib, vandetanib, vemurafenib, vismodegib, or any combination thereof, wherein the subject demonstrates a tumor response and / or molecular response, and wherein metastases are prevented and / or decreased.

[0040] Disclosed herein is a method for treating lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising precision cancer treatment comprising a therapeutically effective amount of one or more antineoplastons, wherein the antineoplastons comprise AS2-1 and / or A10, wherein the subject has already received or is actively receiving one or more targeted therapies and wherein the targeted therapies comprise abemaciclib, ado-trastuzumab emtansine, afatinib, alectinib, alemtuzumab,alpelisib, atezolizumab. avelumab, axitinib, bevacizumab, binimetinib, blinatumomab, bosutinib, brentuximab, bngalinib. cabozantinib. carfilzomib, cemiplimab. ceritinib, cetuximab, gilteritinib, cobimetinib, copanlisib, crizotinib, dabrafenib, dacomitinib, daratumumab, dasatinib, denosumab, dinutuximab, durvalumab, duvelisib, elotuzumab, encorafenib, entrectinib, erdafitinib, erlotinib, fam-trastuzumab deruxtecan-nxki, gefitinib, gemtuzumab, ibritumomab tiuxetan. ibrutinib, imatinib. inotuzumab, ipilumumab, ivosidenib, lapatinib. larotrectinib, Lenvatinib, lorlatinib. margetuximab-cmkb, necitumumab, neratinib. nilotinib, niraparib, nivolumab, obinutuzumab, ofatumumab, olaparib, olaratumab, osimertinib, palbociclib, panitumumab, pazopanib, pembrolizumab, pertuzumab, ponatinib, pralsetinib, ramucirumab, regorafenib, ribociclib, rituximab, rucaparib, sorafenib, sunitinib, talazoparib, tivozanib, tositumomab. trametinib, trastuzumab, tucatinib, vandetanib, vemurafenib, vismodegib, or any combination thereof, wherein the subject demonstrates a tumor response and / or molecular response to treatment regimen, and wherein metastases are prevented and / or decreased.IV. DETAILED DESCRIPTION

[0041] The present disclosure describes formulations, compounded compositions, kits, capsules, containers, and / or methods thereof. It is to be understood that the inventive aspects of which are not limited to specific synthetic methods unless otherwise specified, or to particular reagents unless otherwise specified, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular aspects only and is not intended to be limiting. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, example methods and materials are now described.

[0042] All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and / or materials in connection with which the publications are cited. The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention.A. Abbreviations

[0043] The following abbreviations are used herein: am (amplification); AS (Antineoplaston AS2-1); BC (Burzynski Clinic, site of the study reported herein); BRA (brain metastases); CH (chemotherapy); CR (complete response); CR* (complete response not confirmed by the follow-up scan); DAMA (discontinued against medical advice); Dd (patient died from their malignancy while on treatment); De (patient died from something other than their malignancywhile on treatment); Dx (patient died while on treatment, cause not documented); DEPB (dasatinib, everolimus, pazopanib, bevacizumab); DESB (dasatinib, everolimus. sorafenib, bevacizumab); ER+ (estrogen positive); GBM (glioblastoma, glioblastoma multiforme); H (hormonal treatment); HER-2" (HER-2" negative); HER-2+(EIER-2 positive); IM (improvement); LMN (leptomeningeal metastases); LYM (lymph node metastases); MR (minor response); ND (non-detectable); OR (objective response); OS (overall survival from treatment start); OSS (bone metastases); PE (physical examination); PR (partial response); PR+(progesterone positive); PUL (pulmonary metastases); RT (radiation therapy); SKI (skin metastases); SU (surgery, the number before indicates how many); TN BC (triple negative breast cancer); and TT (targeted therapy, in parenthesis is target of TT).B. Definitions

[0044] Before the present compounds, compositions, articles, systems, devices, and / or methods are disclosed and described, it is to be understood that they are not limited to specific synthetic methods unless otherwise specified, or to particular reagents unless otherwise specified, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular aspects only and is not intended to be limiting. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, example methods and materials are now described.

[0045] This disclosure describes inventive concepts with reference to specific examples. However, the intent is to cover all modifications, equivalents, and alternatives of the inventive concepts that are consistent with this disclosure.

[0046] As used in the specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise.

[0047] The phrase "consisting essentially of' limits the scope of a claim to the recited components in a composition or the recited steps in a method as well as those that do not materially affect the basic and novel characteristic or characteristics of the claimed composition or claimed method. The phrase "consisting of' excludes any component, step, or element that is not recited in the claim. The phrase "comprising" is synonymous with "including", "containing", or "characterized by", and is inclusive or open-ended. "Comprising" does not exclude additional, unrecited components or steps.

[0048] In an aspect, when referring to any numerical value, the term "about" means a value falling within a range that is ± 10% of the stated value.

[0049] Ranges can be expressed herein as from "about" one particular value, and / or to "about" another particular value. When such a range is expressed, a further aspect includes from the one particular value and / or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent "about," it will be understood that the particular value forms a further aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint and independently of the other endpoint. It is also understood that there are a number of values disclosed herein, and that each value is also herein disclosed as "about" that particular value in addition to the value itself. For example, if the value "10" is disclosed, then "about 10" is also disclosed. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0050] References in the specification and concluding claims to parts by weight of a particular element or component in a composition denotes the weight relationship between the element or component and any other elements or components in the composition or article for which a part by weight is expressed. Thus, in a compound containing 2 parts by weight component X and 5 parts by weight component Y, X and Y are present at a weight ratio of 2:5. and are present in such ratio regardless of whether additional components are contained in the compound.

[0051] In an aspect, the terms "optional" or "optionally" means that the subsequently described event or circumstance can or cannot occur, and that the description includes instances where said event or circumstance occurs and instances where it does not. In an aspect, a disclosed method can optionally comprise one or more additional steps, such as, for example, repeating an administering step or altering an administering step.

[0052] In an aspect, the term "subject" refers to the target of administration, e.g., a human being. The term "subject" also includes domesticated animals (e.g.. cats, dogs, etc.), livestock (e.g., cattle, horses, pigs, sheep, goats, etc.), and laboratory animals (e.g., mouse, rabbit, rat, guinea pig, fruit fly, etc.). Thus, the subject of the herein disclosed methods can be a vertebrate, such as a mammal, a fish, a bird, a reptile, or an amphibian. Alternatively, the subject of the herein disclosed methods can be a human, non-human primate, horse, pig, rabbit, dog, sheep, goat, cow, cat. guinea pig, or rodent. The term does not denote a particular age or sex, and thus, adult and child subjects, as well as fetuses, whether male or female, are intended to be covered. In an aspect, a subject can be a human patient. In an aspect, a subject can have lung cancer, be suspected of having lung cancer, or be at risk of developing lung cancer.

[0053] In an aspect, the term "diagnosed" means having been subjected to an examination by a person of skill, for example, a physician, and found to have a condition that can be diagnosedor treated by one or more of the disclosed treatment regimens, disclosed antineoplastons, disclosed pharmaceutical formulations, disclosed biosimilars, disclosed targeted therapies, disclosed chemotherapeutic agents, disclosed anti-cancer agents, or any combination thereof, or by one or more of the disclosed methods. For example, "diagnosed with a disease or disorder" means having been subjected to an examination by a person of skill, for example, a physician, and found to have a condition (such as cancer) that can be treated by one or more of the disclosed treatment regimens, disclosed antineoplastons, disclosed pharmaceutical formulations, disclosed biosimilars, disclosed targeted therapies, disclosed chemotherapeutic agents, disclosed anti-cancer agents, or any combination thereof, or by one or more of the disclosed methods. For example, "suspected of having a disease or disorder" can mean having been subjected to an examination by a person of skill, for example, a physician, and found to have a condition (such as cancer) that can likely be treated by one or more of the disclosed treatment regimens, disclosed antineoplastons, disclosed pharmaceutical formulations, disclosed biosimilars, disclosed targeted therapies, disclosed chemotherapeutic agents, disclosed anti-cancer agents, or any combination thereof, or by one or more of the disclosed methods. In an aspect, an examination can be physical, can involve various tests (e.g., blood tests, genotyping, biopsies, etc.), scans (e.g., CT scans, PET scans, etc.), and assays (e.g., enzymatic assay), or a combination thereof.

[0054] A "patient" refers to a subject afflicted with a disease or disorder (e.g., lung cancer, terminal lung cancer, metastatic lung cancer). In an aspect, a patient can refer to a subject that has been diagnosed with or is suspected of having a disease or disorder such as lung cancer. In an aspect, a patient can refer to a subject that has been diagnosed with or is suspected of having a disease or disorder and is seeking treatment or receiving treatment for a disease or disorder (such as lung cancer).

[0055] In an aspect, the phrase "identified to be in need of treatment for a disease or disorder," or the like, refers to selection of a subject based upon need for treatment of the disease or disorder. For example, a subject can be identified as having a need for treatment of a disease or disorder (e.g., lung cancer) based upon an earlier diagnosis by a person of skill and thereafter subjected to treatment for the lung cancer. In an aspect, the identification can be performed by a person different from the person making the diagnosis. In an aspect, the administration can be performed by one who performed the diagnosis.

[0056] In an aspect, "inhibit," "inhibiting", and "inhibition" mean to diminish or decrease an activity, level, response, condition, severity, disease, or other biological parameter. This can include, but is not limited to, the complete ablation of the activity, level, response, condition,severity, disease, or other biological parameter (such as, for example, one or more genomic aberrations). This can also include, for example, a 10% inhibition or reduction in the activity, level, response, condition, severity’, disease, or other biological parameter (such as, for example, one or more genomic aberrations) as compared to the native or control level (e.g., a subject not receiving one or more of the disclosed treatment regimens, disclosed antineoplastons, disclosed pharmaceutical formulations, disclosed biosimilars, disclosed targeted therapies, disclosed chemotherapeutic agents, disclosed anti-cancer agents, or any combination thereof). Thus, in an aspect, the inhibition or reduction can be a 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, or any amount of reduction in between as compared to native or control levels. In an aspect, the inhibition or reduction can be 10-20%, 20-30%, 30-40%, 40-50%, 50-60%, 60-70%. 70-80%, 80-90%, or 90-100% as compared to a native or control level (e.g., a subject not receiving one or more of the disclosed treatment regimens, disclosed antineoplastons, disclosed pharmaceutical formulations, disclosed biosimilars, disclosed targeted therapies, disclosed chemotherapeutic agents, disclosed anti-cancer agents, or any combination thereof). In an aspect, the inhibition or reduction can be 0-25%. 25-50%, 50-75%, or 75-100% as compared to native or control levels. In an aspect, a native or control level can be a pre-disease or pre-disorder level (such as a pre-lung cancer state).

[0057] The words "treat" or "treating" or "treatment" include palliative treatment, that is, treatment designed for the relief of symptoms rather than the curing of the disease, pathological condition, or disorder; preventative treatment, that is. treatment directed to minimizing or partially or completely inhibiting the development of the associated disease, pathological condition, or disorder; and supportive treatment, that is, treatment employed to supplement another specific therapy directed toward the improvement of the associated disease, pathological condition, or disorder. In an aspect, the terms cover any treatment of a subject, including a mammal (e.g., a human), and includes: (i) preventing the undesired physiological change, disease, pathological condition, or disorder from occurring in a subject that can be predisposed to the disease but has not yet been diagnosed as having it; (ii) inhibiting the physiological change, disease, pathological condition, or disorder, i.e.. arresting its development; or (iii) relieving the physiological change, disease, pathological condition, or disorder, i.e., causing regression of the disease. For example, in an aspect, treating a disease or disorder can reduce the severity- of an established a disease or disorder in a subject by 1%- 100% as compared to a control (such as, for example, an individual not having lung cancer and / or metastatic lung cancer). In an aspect, treating can refer to a 1%. 2%, 3%, 4%. 5%, 6%, 7%, 8%, 9%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 100% reduction in theseverity of a disease or disorder (such as lung cancer and / or metastatic lung cancer). For example, treating a disease or disorder can reduce one or more symptoms of a disease or disorder in a subject by 1 %- 100% as compared to a control (such as, for example, an individual not having lung cancer and / or metastatic lung cancer). In an aspect, treating can refer to 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100% reduction of one or more symptoms of an established a disease or disorder. It is understood that treatment does not necessarily refer to a cure or complete ablation or eradication of a disease or disorder. However, in an aspect, treatment can refer to a cure or complete ablation or eradication of a disease or disorder (such as lung cancer and / or metastatic lungcancer).

[0058] In an aspect, the term "prevent" or "preventing" or "prevention" refers to precluding, averting, obviating, forestalling, stopping, or hindering something from happening, especially by advance action. It is understood that where reduce, inhibit, or prevent are used herein, unless specifically indicated otherwise, the use of the other two words is also expressly disclosed. In an aspect, preventing a disease or disorder having chromatin deregulation and / or chromatin dysregulation is intended. The words "prevent", "preventing", and "prevention" also refer to prophylactic or preventative measures for protecting or precluding a subject (e.g., an individual) not having a given a disease or disorder (such as lung cancer) or related complication from progressing to that complication. In an aspect, preventing metastasis is intended.

[0059] In an aspect, the terms "administering" and "administration" refer to any method of providing one or more of the disclosed treatment regimens, disclosed antineoplastons, disclosed pharmaceutical formulations, disclosed biosimilars, disclosed targeted therapies, disclosed chemotherapeutic agents, disclosed anti-cancer agents, or any combination thereof to a subject. Such methods are well known to those skilled in the art and include, but are not limited to, the following: oral administration, transdermal administration, administration by inhalation, nasal administration, topical administration, in utero administration, intratumoral administration, intrahepatic administration, intravaginal administration, ophthalmic administration, intraaural administration, otic administration, intracerebral administration, rectal administration, sublingual administration, buccal administration, and parenteral administration, including injectable such as intravenous administration, intra-CSF administration, intra-arterial administration, intramuscular administration, and subcutaneous administration. Administration can also include hepatic intra-arterial administration or administration through the hepatic portal vein (HPV). Administration of one or more of the disclosed treatment regimens, disclosed antineoplastons, disclosed pharmaceuticalformulations, disclosed biosimilars, disclosed targeted therapies, disclosed chemotherapeutic agents, disclosed anti-cancer agents, or any combination thereof can comprise administration directly into the CNS or the PNS. Administration can be continuous or intermittent. Administration can comprise a combination of one or more routes. In an aspect, administering can comprise titrating one or more of the disclosed treatment regimens, disclosed antineoplastons, disclosed pharmaceutical formulations, disclosed biosimilars, disclosed targeted therapies, disclosed chemotherapeutic agents, disclosed anti-cancer agents, or any combination thereof to identify an effective dose and / or to identify an effective dose eliciting only mild adverse and / or side effects.

[0060] As known to the art, a disclosed small molecule can include any organic or inorganic material that is not a polymer. As known to the art, a disclosed small molecule can exclude large macromolecules, such as large proteins (e.g., proteins with molecular weights over 2,000, 3,000, 4,000, 5,000, 6,000, 7,000, 8,000, 9,000, or 10,000), large nucleic acids (e.g., nucleic acids with molecular weights of over 2,000, 3,000, 4,000, 5,000, 6,000, 7,000, 8,000, 9,000, or 10,000), or large polysaccharides (e.g., polysaccharides with a molecular weight of over 2,000, 3,000, 4.000. 5,000, 6.000, 7,000. 8.000, 9,000. or 10,000). In an aspect, a "small molecule", for example, can be a drug that can enter cells easily because it has a low molecular weight. In an aspect, a small molecule can be used in conjunction with a disclosed composition or a disclosed formulation in a disclosed method.

[0061] In an aspect, "disease-free survival" and "DFS" can refer to the length of time after a primary treatment (e g., ANP therapy) that the patient survives without recurrence of the cancer.

[0062] In an aspect, the skilled person can determine an efficacious dose, an efficacious schedule, and an efficacious route of administration for one or more of the disclosed treatment regimens, disclosed antineoplastons, disclosed pharmaceutical formulations, disclosed biosimilars, disclosed targeted therapies, disclosed chemotherapeutic agents, disclosed anticancer agents, or any combination thereof to treat or prevent a disease or disorder (such as lung cancer and / or metastatic lung cancer). In an aspect, the skilled person can also alter, change, or modify an aspect of an administering step to improve efficacy of one or more of the disclosed treatment regimens, disclosed antineoplastons, disclosed pharmaceutical formulations, disclosed biosimilars, disclosed targeted therapies, disclosed chemotherapeutic agents, disclosed anti-cancer agents, or any combination thereof.

[0063] In an aspect, "biocompatible" can refer to a material and any metabolites or degradation products thereof that are generally non-toxic to the recipient and do not cause significant adverse effects to the subject.

[0064] By "determining the amount" is meant both an absolute quantification of a particular analyte (e.g., biomarker for lung cancer and / or metastatic lung cancer, for example) or a determination of the relative abundance of a particular analyte (e.g., a lung cancer and / or metastatic lung cancer biomarker). The phrase includes both direct or indirect measurements of abundance or both.

[0065] In an aspect, "modifying the method" can comprise modifying or changing one or more features or aspects of one or more steps of a disclosed method of treating lung cancer and / or metastatic lung cancer. In an aspect, a method can be altered by changing the amount of one or more of the disclosed treatment regimens, disclosed antineoplastons, disclosed pharmaceutical formulations, disclosed biosimilars, disclosed targeted therapies, disclosed chemotherapeutic agents, disclosed anti-cancer agents, or any combination thereof administered to a subject, or by changing the frequency of administration one or more of the disclosed treatment regimens, disclosed antineoplastons, disclosed pharmaceutical formulations, disclosed biosimilars, disclosed targeted therapies, disclosed chemotherapeutic agents, disclosed anti-cancer agents, or any combination thereof to a subject, by changing the duration of time that one or more of the disclosed treatment regimens, disclosed antineoplastons, disclosed pharmaceutical formulations, disclosed biosimilars, disclosed targeted therapies, disclosed chemotherapeutic agents, disclosed anti-cancer agents, or any combination thereof is administered to a subject, or by substituting for one or more of the disclosed components and / or reagents with a similar or equivalent component and / or reagent. The same applies to one or more of the disclosed treatment regimens, disclosed antineoplastons, disclosed pharmaceutical formulations, disclosed biosimilars, disclosed targeted therapies, disclosed chemotherapeutic agents, disclosed anti-cancer agents, or any combination thereof.

[0066] In an aspect, the term "pharmaceutically acceptable carrier" refers to sterile aqueous or nonaqueous solutions, dispersions, suspensions or emulsions, as well as sterile powders for reconstitution into sterile injectable solutions or dispersions just prior to use. Examples of suitable aqueous and nonaqueous carriers, diluents, solvents, or vehicles include water, ethanol, polyols (such as glycerol, propylene glycol, polyethylene glycol and the like), carboxymethylcellulose and suitable mixtures thereof, vegetable oils (such as olive oil) and injectable organic esters such as ethyl oleate. In an aspect, a pharmaceutical carrier employedcan be a solid, liquid, or gas. In an aspect, examples of solid carriers can include lactose, terra alba, sucrose, talc, gelatin, agar, pectin, acacia, magnesium stearate, and stearic acid. In an aspect, examples of liquid earners can include sugar syrup, peanut oil, olive oil, and water. In an aspect, examples of gaseous carriers can include carbon dioxide and nitrogen. In preparing a disclosed composition for oral dosage form, any convenient pharmaceutical media can be employed. For example, water, glycols, oils, alcohols, flavoring agents, preservatives, coloring agents and the like can be used to form oral liquid preparations such as suspensions, elixirs and solutions; while carriers such as starches, sugars, microcrystalline cellulose, diluents, granulating agents, lubricants, binders, disintegrating agents, and the like can be used to form oral solid preparations such as powders, capsules and tablets. Because of their ease of administration, tablets and capsules are the preferred oral dosage units whereby solid pharmaceutical carriers are employed. Optionally, tablets can be coated by standard aqueous or nonaqueous techniques. Proper fluidity can be maintained, for example, by the use of coating materials such as lecithin, by the maintenance of the required particle size in the case of dispersions and by the use of surfactants. These compositions can also contain adjuvants such as preservatives, wetting agents, emulsifying agents and dispersing agents. Prevention of the action of microorganisms can be ensured by the inclusion of various antibacterial and antifungal agents such as paraben, chlorobutanol, phenol, sorbic acid and the like. It can also be desirable to include isotonic agents such as sugars, sodium chloride and the like. Prolonged absorption of the injectable pharmaceutical form can be brought about by the inclusion of agents, such as aluminum monostearate and gelatin, which delay absorption. Injectable depot forms are made by forming microencapsule matrices of the drug in biodegradable polymers such as polylactide-polyglycolide. poly (orthoesters) and poly(anhydrides). Depending upon the ratio of drug to polymer and the nature of the particular polymer employed, the rate of drug release can be controlled. Depot injectable formulations are also prepared by entrapping the drug in liposomes or microemulsions that are compatible with body tissues. The injectable formulations can be sterilized, for example, by filtration through a bacterial-retaining filter or by incorporating sterilizing agents in the form of sterile solid compositions which can be dissolved or dispersed in sterile water or other sterile injectable mediajust priorto use. Suitable inert carriers can include sugars such as lactose. Desirably, at least 95% by weight of the particles of the active ingredient have an effective particle size in the range of 0.01 to 10 micrometers.

[0067] In an aspect, the term "excipient" refers to an inert substance that is commonly used as a diluent, vehicle, preservative, binder, or stabilizing agent, and includes, but is not limited to,proteins (e.g., serum albumin, etc.), amino acids (e.g., aspartic acid, glutamic acid, lysine, arginine, glycine, histidine, etc.), fatty acids and phospholipids (e.g.. alkyl sulfonates, caprylate, etc.), surfactants (e.g., SDS, polysorbate, nonionic surfactant, etc.), saccharides (e.g., sucrose, maltose, trehalose, etc.) and polyols (e.g., mannitol, sorbitol, etc.). See also, for reference, Remington's Pharmaceutical Sciences, (1990) Mack Publishing Co., Easton, Pa., which is hereby incorporated by reference in its entirety. In an aspect, acceptable carriers, excipients, or stabilizers are nontoxic to recipients at the dosages and concentrations used herein, and can include buffers such as, but not limited to phosphate, citrate, and other organic acids; antioxidants including ascorbic acid and methionine; preservatives (such as octadecyldimethylbenzyl ammonium chloride; hexamethonium chloride; benzalkonium chloride, benzethonium chloride; phenol, butyl or benzyl alcohol; alkyl parabens such as methyl or propyl paraben; catechol; resorcinol; cyclohexanol; 3-pentanol; and m-cresol); low molecular weight (less than about 10 residues) polypeptides; proteins, such as serum albumin, gelatin, or immunoglobulins; hydrophilic polymers such as polyvinylpyrrolidone; amino acids such as glycine, glutamine, asparagine, histidine, arginine, or lysine; monosaccharides, disaccharides, and other carbohydrates including glucose, mannose, or dextrans; chelating agents such as EDTA; sugars such as sucrose, mannitol, trehalose or sorbitol; salt-forming counter-ions such as sodium; metal complexes (e.g., Zn-protein complexes); and / or non-ionic surfactants such as Tween. Pluronics, or polyethylene glycol (PEG).

[0068] In an aspect, "concurrently" means (1) simultaneously in time, or (2) at different times during the course of a common treatment schedule.

[0069] In an aspect, the term "contacting" refers to bringing one or more of the disclosed precision lung cancer and / or metastatic lung cancer treatments, the disclosed treatment regimens, disclosed antineoplastons, disclosed pharmaceutical formulations, disclosed biosimilars, disclosed targeted therapies, disclosed chemotherapeutic agents, disclosed anticancer agents, or any combination thereof together with a target area or intended target area in such a manner that a disclosed precision lung cancer and / or metastatic lung cancer treatment, one or more of the disclosed treatment regimens, disclosed antineoplastons, disclosed pharmaceutical formulations, disclosed biosimilars, disclosed targeted therapies, disclosed chemotherapeutic agents, disclosed anti-cancer agents, or any combination thereof can exert an effect on the intended target or targeted area either directly or indirectly. A target area or intended target area can be one or more of a subject's organs (e.g., lungs, heart, liver, kidney, brain, etc.) hosting lung cancer cells and / or metastatic lung cancerous cells. In an aspect, a target area or intended target area can be any cell or any organ infected by a disease or disorder(such as lung cancer and / or metastatic lung cancer). In an aspect, a target area or intended target area can be any organ, tissue, or cells that are affected by a disease or disorder (such as lung cancer and / or metastatic lung cancer).

[0070] In an aspect, "determining" can refer to measuring or ascertaining the presence and severity' of a disease or disorder, such as, for example, lung cancer and / or metastatic lung cancer. Methods and techniques used to determine the presence and / or severity of a disease or disorder are typically known to the medical arts. For example, the art is familiar with the ways to identify and / or diagnose the presence, severity, or both of a disease or disorder (such as, for example, lung cancer and / or metastatic lung cancer).

[0071] In an aspect, "effective amount" and "amount effective" can refer to an amount that is sufficient to achieve the desired result such as. for example, the treatment and / or prevention of a disease or disorder (e.g., a lung cancer and / or metastatic lung cancer) or a suspected disease or disorder. In an aspect, the terms "effective amount" and "amount effective" can refer to an amount that is sufficient to achieve the desired an effect on an undesired condition (e.g., a lung cancer and / or metastatic lung cancer). For example, a "therapeutically effective amount" refers to an amount that is sufficient to achieve the desired therapeutic result or to have an effect on undesired symptoms, but is generally insufficient to cause adverse side effects. In an aspect, "therapeutically effective amount" means an amount of one or more of the disclosed treatment regimens, disclosed antineoplastons, disclosed pharmaceutical formulations, disclosed biosimilars, disclosed targeted therapies, disclosed chemotherapeutic agents, disclosed anticancer agents, or any combination thereof that (i) treats the particular disease, condition, or disorder (e.g., a cancer), (ii) attenuates, ameliorates, or eliminates one or more symptoms of the particular disease, condition, or disorder e.g.. cancer), or (iii) delays the onset of one or more symptoms of the particular disease, condition, or disorder described herein (e.g., cancer). The specific therapeutically effective dose level for any particular patient will depend upon a variety of factors including the disorder being treated and the severity of the disorder; the one or more of the disclosed treatment regimens, disclosed antineoplastons, disclosed pharmaceutical formulations, disclosed biosimilars, disclosed targeted therapies, disclosed chemotherapeutic agents, disclosed anti-cancer agents, or any combination thereof employed; the disclosed methods employed; the age, body weight, general health, sex and diet of the patient; the time of administration; the route of administration; the rate of excretion of the one or more of the disclosed treatment regimens, disclosed antineoplastons, disclosed pharmaceutical formulations, disclosed biosimilars, disclosed targeted therapies, disclosed chemotherapeutic agents, disclosed anti-cancer agents, or any combination thereof employed;the duration of the treatment; drugs used in combination or coincidental with one or more of the disclosed treatment regimens, disclosed antineoplastons, disclosed pharmaceutical formulations, disclosed biosimilars, disclosed targeted therapies, disclosed chemotherapeutic agents, disclosed anti-cancer agents, or any combination thereof employed, and other like factors well known in the medical arts. For example, it is well within the skill of the art to start doses of the disclosed treatment regimen, the disclosed antineoplaston, the disclosed targeted therapy, the disclosed biosimilar, the disclosed pharmaceutical formulation, the disclosed anti- chemokine, the disclosed anti-cancer agent, the disclosed chemotherapeutic agent, or the combination thereof at levels low er than those required to achieve the desired therapeutic effect and to gradually increase the dosage until the desired effect is achieved. If desired, then the effective daily dose can be divided into multiple doses for purposes of administration. Consequently, a single dose of the disclosed treatment regimen, the disclosed antineoplaston, the disclosed targeted therapy, the disclosed pharmaceutical formulation, the disclosed anti- chemokine, the disclosed anti-cancer agent, the disclosed chemotherapeutic agent, or the combination thereof can contain such amounts or submultiples thereof to make up the daily dose. The dosage can be adjusted by the individual physician in the event of any contraindications. Dosage can vary, and can be administered in one or more dose administrations daily, for one or several days. Guidance can be found in the literature for appropriate dosages for given classes of pharmaceutical products. In further various aspects, a preparation can be administered in a "prophy lactically effective amount"; that is. an amount effective for prevention of a disease or condition, such as, for example, a disease or disorder due to a missing, deficient, and / or mutant protein or enzyme.

[0072] In an aspect, a "monoclonal antibody" refers to homogenous antibody population involved in the highly specific recognition and binding of a single antigenic determinant, or epitope. This is in contrast to polyclonal antibodies that typically include different antibodies directed against different antigenic determinants. The term "monoclonal antibody" encompasses both intact and full-length monoclonal antibodies as well as antibody fragments (such as Fab, Fab', F(ab')2, Fv), single chain (scFv) mutants, fusion proteins comprising an antibody portion, and any other modified immunoglobulin molecule comprising an antigen recognition site. Furthermore, "monoclonal antibody" refers to such antibodies made in any number of manners including, but not limited to, by hybridoma, phage selection, recombinant expression, and transgenic animals.

[0073] In an aspect, the term "humanized antibody" refers to forms of non-human (e.g., murine) antibodies that are specific immunoglobulin chains, chimeric immunoglobulins, orfragments thereof that contain minimal non-human sequences. Typically, humanized antibodies are human immunoglobulins in which residues from the complementary determining region (CDR) are replaced by residues from the CDR of a non-human species (e.g., mouse, rat, rabbit, hamster, etc.) that have the desired specificity, affinity, and capability. In some instances, the Fv framework region (FR) residues of a human immunoglobulin are replaced with the corresponding residues in an antibody from a non-human species that has the desired specificity, affinity, and capability. The humanized antibody can be further modified by the substitution of additional residue either in the Fv framework region and / or within the replaced non-human residues to refine and optimize antibody specificity, affinity, and / or capability. In general, the humanized antibody will comprise substantially all of at least one, and typically two or three, variable domains containing all or substantially all of the CDR regions that correspond to the non-human immunoglobulin whereas all or substantially all of the FR regions are those of a human immunoglobulin consensus sequence. The humanized antibody can also comprise at least a portion of an immunoglobulin constant region or domain (Fc), typically that of a human immunoglobulin.

[0074] That an antibody "selectively binds" or "specifically binds" to an epitope or receptor means that the antibody reacts or associates more frequently, more rapidly, with greater duration, with greater affinity, or with some combination of the above to the epitope or receptor than with alternative substances, including unrelated proteins. "Selectively binds" or "specifically binds" means, for instance, that an antibody binds to a protein with a KD of about 0.1 mM or less, more usually about 1 pM or less. "Selectively binds" or "specifically binds" means at times that an antibody binds to a protein with a KD of about 0. 1 mM or less, at times about 1 pM or less, at times about 0.1 pM or less, at times about 0.01 pM or less, and at times about 1 nM or less. It is understood that, in certain aspects, an antibody or binding moiety that specifically binds to a first target may or may not specifically bind to a second target. As such, "specific binding" does not necessarily require (although it can include) exclusive binding, e.g., binding to a single target.

[0075] Polyclonal antibodies can be prepared by any known method. Polyclonal antibodies are raised by immunizing an animal (e.g., a rabbit, rat, mouse, donkey, goat, etc.) by multiple subcutaneous or intraperitoneal injections of the relevant antigen (a purified peptide fragment, full-length recombinant protein, fusion protein, etc.) optionally conjugated to keyhole limpet hemocyanin (KLH), serum albumin, etc. diluted in sterile saline and combined with an adjuvant (e.g.. Complete or Incomplete Freund's Adjuvant) to form a stable emulsion. The polyclonal antibody is then recovered from blood, ascites and the like, of an animal so immunized.Collected blood is clotted, and the serum decanted, clarified by centrifugation, and assayed for antibody titer. The polyclonal antibodies can be purified from serum or ascites according to standard methods in the art including affinity chromatography, ion-exchange chromatography, gel electrophoresis, dialysis, etc.

[0076] In an aspect, "precision medicine" methods and "precision cancer treatment" can be used interchangeably and refer to methods of administering a cancer treatment (e.g., a ANP therapy) to a subject after measuring the subject's molecular markers to assess the likelihood of response or lack of response of a particular cancer therapy. In an aspect, for example, precision cancer treatment can comprise ANP and one or more other targeted therapeutic agents (which can be determined using a disclosed genomic analysis). For lung cancer treatment, precision medicine means measuring a subject's molecular markers to select treatments that are most likely to help the subject, while at the same time sparing the subject from getting treatments that are not likely to help. In an aspect, molecular markers disclosed herein can be used for identification of one or more precision cancer treatments to be administered to a subject herein and / or can be determined by assessing the genetic expression of one or more lung cancer related genes. In an aspect, molecular markers disclosed herein can be used for identification of one or more precision cancer treatments to be administered to a subject herein, and can be an increase in expression of one or more cancer related genes compared to that of a healthy subject not having or suspected of having a lung cancer. In an aspect, molecular markers disclosed herein can be used for identification of one or more precision cancer treatments to be administered to a subject herein, and can decrease in expression of one or more cancer related genes compared to that of a healthy subject not having or suspected of having a lung cancer. In an aspect, molecular markers disclosed herein can be used for identification of one or more precision cancer treatments to be administered to a subject herein, and can be a base mutation and / or variant in the sequence of one or more lung cancer related genes compared to that of a healthy subject not having or suspected of having a lung cancer.

[0077] In an aspect, the terms "cancer" and "cancerous" refer to or describe the physiological condition in mammals in which a population of cells are characterized by unregulated cell growth. Examples of cancer include, but are not limited to, carcinoma, lymphoma, blastoma, sarcoma, and leukemia. More particular examples of such cancers include squamous cell cancer, small-cell lung cancer, non-small cell lung cancer, adenocarcinoma of the lung, squamous carcinoma of the lung, cancer of the peritoneum, hepatocellular cancer, gastrointestinal cancer, pancreatic cancer, glioblastoma, cervical cancer, ovarian cancer, liver cancer, bladder cancer, hepatoma, breast cancer, colon cancer, colorectal cancer, endometrialor uterine carcinoma, salivary gland carcinoma, kidney cancer, liver cancer, prostate cancer, vulval cancer, thyroid cancer, hepatic carcinoma, various types of head and neck cancer, various types of brain tumors, or any combination thereof.

[0078] The terms "proliferative disorder" and "proliferative disease" refer to disorders associated with abnormal cell proliferation such as lung cancer.

[0079] In an aspect, "tumor" and "neoplasm" refer to any mass of tissue that result from excessive cell growth or proliferation, either benign (noncancerous) or malignant (cancerous) including pre-cancerous lesions. In an aspect, "metastasis" refers to the process by which a cancer spreads or transfers from the site of origin to other regions of the body with the development of a similar cancerous lesion at the new location. A "metastatic" or "metastasizing" cell is one that loses adhesive contacts with neighboring cells and migrates via the bloodstream or lymph from the primary site of disease to invade neighboring body structures.

[0080] The terms "cancer stem cell" or "tumor stem cell" or "solid tumor stem cell" are used interchangeably herein and refer to a population of cells from a solid tumor that: (1) have extensive proliferative capacity: (2) are capable of asymmetric cell division to generate one or more kinds of differentiated progeny with reduced proliferative or developmental potential; and (3) are capable of symmetric cell divisions for self-renewal or self-maintenance. These properties of "cancer stem cells" or "tumor stem cells" or "solid tumor stem cells" confer on those cancer stem cells the ability to form palpable tumors upon serial transplantation into an immunocompromised mouse compared to the majority of tumor cells that fail to form tumors. Cancer stem cells undergo self-renewal versus differentiation in a chaotic manner to form tumors with abnormal cell types that can change over time as mutations occur.

[0081] The terms "cancer cell" or "tumor cell" and grammatical equivalents refer to the total population of cells derived from a tumor including both non-tumorigenic cells, which comprise the bulk of the tumor cell population, and tumorigenic stem cells (cancer stem cells).

[0082] In an aspect "tumorigenic" refers to the functional features of a solid tumor stem cell including the properties of self-renewal (giving rise to additional tumorigenic cancer stem cells) and proliferation to generate all other tumor cells (giving rise to differentiated and thus non-tumorigenic tumor cells) that allow solid tumor stem cells to form a tumor.

[0083] In an aspect, the "tumorigenicity " of a tumor refers to the ability' of a random sample of cells from the tumor to form palpable tumors upon serial transplantation into immunocompromised mice.

[0084] In an aspect, "immune-modulating" refers to the ability of one or more of the disclosed treatment regimens, disclosed antineoplastons, disclosed pharmaceutical formulations, disclosed biosimilars, disclosed targeted therapies, disclosed chemotherapeutic agents, disclosed anti-cancer agents, or any combination thereof to alter (modulate) one or more aspects of the immune system. The immune system functions to protect the organism from infection and from foreign antigens by cellular and humoral mechanisms involving lymphocytes, macrophages, and other antigen-presenting cells that regulate each other by means of multiple cell-cell interactions and by elaborating soluble factors, including lymphokines and antibodies, that have autocrine, paracrine, and endocrine effects on immune cells.

[0085] In an aspect, "immune modulator" refers to an agent that is capable of adjusting a given immune response to a desired level (e.g., as in immunopotentiation, immunosuppression, or induction of immunologic tolerance). Examples of immune modulators include but are not limited to, a disclosed immune modulator can comprise aspirin, azathioprine, belimumab, betamethasone dipropionate, betamethasone valerate, bortezomib, bredinin, cyazathioprine, cyclophosphamide, cyclosporine, deoxyspergualm. didemnm B, fluocinolone acetonide, folinic acid, ibuprofen, IL6 inhibitors (such as sarilumab) indomethacin, inebilizumab, intravenous gamma globulin (IVIG), methotrexate, methylprednisolone, mycophenolate mofetil, naproxen, prednisolone, prednisone, prednisolone indomethacin, rapamycin, rituximab, sirolimus, sulindac. synthetic vaccine particles containing rapamycin (SVP- Rapamycin or ImmTOR), thalidomide, tocilizumab, tolmetin, triamcinolone acetonide, anti- CD3 antibodies, anti-CD4 antibodies, anti-CD19 antibodies, anti-CD20 antibodies, anti-CD22 antibodies, anti-CD40 antibodies, anti-FcRN antibodies, anti-IL6 antibodies. anti-IGFIR antibodies, an IL2 mutein, a BTK inhibitor, or a combination thereof. In an aspect, a disclosed immune modulator can comprise one or more Treg (regulatory T cells) infusions (e.g., antigen specific Treg cells to AAV). In an aspect, a disclosed immune modulator can be bortezomib or SVP-Rapamycin. In an aspect, an immune modulator can be administered by any suitable route of administration including, but not limited to, in utero, intra-CSF, intrathecally, intravenously, subcutaneously, transdermally. intradermally, intramuscularly, orally, transcutaneously, intraperitoneally (IP), or intravaginally. In an aspect, a disclosed immune modulator can be administered using a combination of routes. Administration can also include hepatic intra-arterial administration or administration through the hepatic portal vein (HPV). Administration of an immune modulator can be continuous or intermittent, and administration can comprise a combination of one or more routes.

[0086] In an aspect, the term "package insert" is used to refer to instructions customarily included in commercial packages of therapeutic products, that contain information about the indications, usage, dosage, administration, contraindications and / or warnings concerning the use of such therapeutic products.

[0087] In an aspect, the term "in combination" in the context of the administration of other therapies (e.g., other agents) includes the use of more than one therapy (e.g., drug therapy). Administration "in combination with" one or more further therapeutic agents includes simultaneous (e g., concurrent) and consecutive administration in any order. The use of the term "in combination" does not restrict the order in which therapies are administered to a subject. By way of non-limiting example, a first therapy (e.g., one or more of the disclosed treatment regimens, disclosed antineoplastons, disclosed pharmaceutical formulations, disclosed biosimilars, disclosed targeted therapies, disclosed chemotherapeutic agents, disclosed anti-cancer agents, or any combination thereof) may be administered prior to (e.g., 1 minute. 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 12 hours. 24 hours, 48 hours, 72 hours, 96 hours, 1 week. 2 weeks, 3 weeks, 4 weeks. 5 weeks. 6 weeks. 8 weeks. 8 weeks. 9 weeks. 10 weeks, 11 weeks, or 12 weeks), concurrently, or after (e.g., 1 minute, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, or 12 weeks or longer) the administration of a second therapy (e.g.. one or more of the disclosed treatment regimens, disclosed antineoplastons, disclosed pharmaceutical formulations, disclosed biosimilars, disclosed targeted therapies, disclosed chemotherapeutic agents, disclosed anti-cancer agents, or any combination thereof) to a subject having or diagnosed with cancer.

[0088] Disclosed are the components to be used to prepare the one or more of the disclosed treatment regimens, disclosed antineoplastons, disclosed pharmaceutical formulations, disclosed biosimilars, disclosed targeted therapies, disclosed chemotherapeutic agents, disclosed anti-cancer agents, or any combination thereof used within the methods disclosed herein. These and other materials are disclosed herein, and it is understood that when combinations, subsets, interactions, groups, etc. of these materials are disclosed that while specific reference of each various individual and collective combinations and permutation of these compounds cannot be explicitly disclosed, each is specifically contemplated and described herein. For example, if a particular compound is disclosed and discussed and a number of modifications that can be made to a number of molecules including the compoundsare discussed, specifically contemplated is each and every combination and permutation of the compound and the modifications that are possible unless specifically indicated to the contrary. Thus, if a class of molecules A, B, and C are disclosed as well as a class of molecules D, E, and F and an example of a combination molecule, A-D is disclosed, then even if each is not individually recited each is individually and collectively contemplated meaning combinations, A-E, A-F, B-D, B-E, B-F, C-D, C-E, and C-F are considered disclosed. Likewise, any subset or combination of these is also disclosed. Thus, for example, the sub-group of A-E. B-F, and C-E would be considered disclosed. This concept applies to all aspects of this application including, but not limited to, steps in methods of making and using the compositions of the invention. Thus, if there are a variety of additional steps that can be performed it is understood that each of these additional steps can be performed with any specific disclosed method or disclosed aspect or combination of disclosed methods or disclosed aspects.C. Compositions for Use in the Disclosed Methods1. Antineoplastons

[0089] Disclosed herein are compositions comprising one or more antineoplastons. Antineoplastons (ANP) are peptides, amino acid derivatives and carboxylic acids that were initially isolated from the blood and urine of healthy subjects.

[0090] Atengenal (A10) can comprise a 4:1 ratio of synthetic phenylacetylglutaminate sodium (PG) and phenylacetylisoglutaminate sodium (iso-PG). PG has a molecular weight of 286.26 and an empirical formula of Ci3HisN2NaO4. PG can be synthesized by the reaction of phenylacetyl chloride with L-glutamine in an aqueous solution containing sodium bicarbonate. PG is a hygroscopic white powder having a melting point of approximately 102 °C and is very soluble in water. The structural formula of PG is:

[0091] Iso-PG has a molecular weight of 286.26 and an empirical formula of Ci3Hi5N2NaO4. Iso-PG can be synthesized by the reaction of phenylacetyl chloride with L-glutamine in an aqueous solution containing sodium bicarbonate to afford PG, which in turn can be heated under vacuum at 160 °C to yield A10C (3-phenylacetylamino-2,6-piperidinedione). When A10C is treated with sodium hydroxide, it can produce a mixture of PG and iso-PG in a 4: 1ratio. Iso-PG is a white powder having a melting point of approximately 175-176 °C and is soluble in water. The structural formula of iso-PG is:

[0092] Astugenal (AS2-1) can comprise phenylacetate (PN) and PG in a 4: 1 ratio. PN is characterized by a molecular weight of 158.63 and an empirical formula of CsHsNaCh. PN can be synthesized by refluxing benzyl cyanide with dilute sulfuric acid or hydrochloric acid. In solid form, PN has a melting point of approximately 76.5° C. The structural formula of PN is:

[0093] In an aspect, "antineoplaston (ANP) therapy" can refer to administration to a subject or patient, by any administration route, of an "ANP therapeutic composition" or a disclosed composition or pharmaceutical formulation comprising one or more antineoplastons (e.g., a therapeutically effective amount of Atengenal (A10), Astugenal (AS2-1), or any combination thereof).

[0094] In an aspect, antineoplastons can comprise capsules and / or tablets for oral administration. In an aspect, antineoplastons can comprise a solution for intravenous administration. In an aspect, A10 tablets / capsules can comprise about 100 mg to about 1000 mg of 3-phenylacetylamino-2, 6-piperidinedione. In an aspect, A10 tablets / capsules can comprise about 100 mg, about 200 mg, about 300 mg, about 400 mg, 500 mg, about 600 mg, about 700 mg, about 800 mg, about 900 mg, or about 1000 mg of 3-phenylacetylamino-2, 6- piperidinedione. In an aspect, A10 tablets / capsules can comprise about 500 mg of 3- phenylacetylamino-2, 6-piperidinedione. In an aspect, A10 can comprise a mixture of the sodium salts of PG and isoPG in a 4: 1 ratio for intravenous injection.

[0095] In an aspect, AS2-1 tablets / capsules can comprise about 100 mg to about 1000 mg of a 4: 1 PN and PG. In an aspect, AS2-1 tablets / capsules can comprise about 100 mg, about 200 mg, about 300 mg, about 400 mg, about 500 mg, about 600 mg, about 700 mg, about 800 mg, about 900 mg, or about 1000 mg. In an aspect, AS2-1 tablets / capsules can comprise about 500 mg of 3-phenylacetylamino-2, 6-piperidinedione. In an aspect. AS2-1 tablets / capsules cancomprise about 500 mg of a 4: 1 PN and PG. In an aspect, AS2-1 can comprise a mixture of PN and PG in a 4: 1 ratio for intravenous injection.

[0096] In an aspect, a disclosed ANP can be used in connection with one or more targeted therapies for lung cancer or metastatic lung cancer.

[0097] In an aspect, a disclosed ANP can be used to treat and / or prevent cancer, to prolong the survival of the subject, to prevent and / or decrease metastases, to protect the subject from metastasis, to reduce the risk of developing metastases, to increase the subject's survivability, to increase the length of time before metastasis, to reduce the likelihood of surgical intervention, to reduce the need for administration of one or more additional therapeutic agents or regimens, to reduce the size of one or more tumors in the subject, to reduce the size of one or more tumors in one or more organs in the subject, to eliminate one or more tumors in the subject, to reduce and / or eliminate the prevalence of one or more genomic aberrations, to restore normal metabolism of one or more organ systems in the subject, to restore one or more aspects of cellular homeostasis, cellular functionality, and / or metabolic dysregulation in a subject, to reduce and / or inhibit aberrant angiogenesis and / or vasculogenesis in one or more tissues and / or organs of the subject, or any combination thereof. In an aspect, a disclosed ANP therapy can be used as a pan-tumor therapy. In an aspect, a disclosed ANP can be used to reducing viability of one or more cancer cells.

[0098] In an aspect, a disclosed ANP can be used such that (i) the risk of developing metastases can be prevented and / or decreased; (ii) the survival of the subject can be prolonged; (iii) the subjects quality of life can be enhanced and / or improved; (iv) the likelihood of surgical intervention can be reduced and / or minimized; (v) preventing and / or delaying recurrence of the cancer; (vi) the size of one or more tumors in the subject can be reduced and / or decreased; (vii) one or more tumors in the subject can be eliminated; (viii) extending and / or prolonging disease-free or tumor-free survival time; (ix) increasing and / or lengthening overall survival time; (x) reducing and / or minimizing the frequency of treatment; (xi) relieving and / or ameliorating one or more symptoms of the cancer; (xii) reducing and / or decreasing tumor burden, (ix) preventing and / or facilitating surgical intervention; (xiii) normal metabolism of one or more organ systems in the subject can be improved and / or restored, (xiv) one or more aspects of cellular homeostasis and / or cellular functionality, and / or metabolic dysregulation can be restored and / or improved, or (xv) any combination thereof.2. Formulations

[0099] Disclosed herein is a pharmaceutical formulation comprising one or more antineoplastons and one or more pharmaceutically acceptable carriers.

[0100] In an aspect of a disclosed pharmaceutical formulation, disclosed antineoplastons can comprise phenylacetate (PN), phenylacetylglutaminate sodium (PG), phenylacetylisoglutaminate sodium (iso-PG), or any combination thereof.

[0101] In an aspect of a disclosed pharmaceutical formulation, the disclosed one or more antineoplastons can comprise phenylacetylglutaminate sodium (PG) and phenylacetylisoglutaminate sodium (iso-PG). In an aspect of a disclosed pharmaceutical formulation, a disclosed ratio of phenylacetylglutaminate sodium (PG) and phenylacetylisoglutaminate sodium (iso-PG) can be about 10: 1, about 9:1, about 8: 1, about 7: 1, about 6: 1, about 5:1, about 4: 1, about 3: 1, about 2: 1, or about 1 : 1. In an aspect of a disclosed pharmaceutical formulation, a disclosed ratio of phenylacetylglutaminate sodium (PG) and phenylacetylisoglutaminate sodium (iso-PG) can range from about 10: 1 to about 1: 10. In an aspect of a disclosed pharmaceutical formulation, a disclosed ratio of phenylacetylglutaminate sodium (PG) and phenylacetylisoglutaminate sodium (iso-PG) can be about 4: 1. In an aspect, a therapeutically effective amount of a disclosed pharmaceutical formulation can comprise about 0. 1 g / kg / day to about 20 g / kg / day .

[0102] In an aspect of a disclosed pharmaceutical formulation, the disclosed one or more antineoplastons can comprise phenylacetate (PN) and phenylacetylglutaminate sodium (PG). In an aspect of a disclosed pharmaceutical formulation, a disclosed ratio of phenylacetate (PN) and phenylacetylglutaminate sodium (PG) can be about 10:1. about 9: 1, about 8: 1, about 7: 1, about 6: 1, about 5: 1. about 4: 1, about 3: 1. about 2: 1, or about 1 : 1. In an aspect of a disclosed pharmaceutical formulation, a disclosed ratio of phenylacetate (PN) and phenylacetylglutaminate sodium (PG) can range from about 10: 1 to about 1: 10. In an aspect of a disclosed pharmaceutical formulation, a disclosed ratio of phenylacetate (PN) and phenylacetylglutaminate sodium (PG) can be about 4: 1. In an aspect, a therapeutically effective amount of a disclosed pharmaceutical formulation can comprise about 0.08 g / kg / day to about 0.6 g / kg / day.

[0103] In an aspect, a disclosed pharmaceutical formulation comprising one or more antineoplastons can comprise bevacizumab, pazopanib, sorafenib, dasatinib, everolimus, or any combination thereof. For example, in an aspect, pazopanib and / or sorafenib can be orally administered to a subject at a dose of from about 1 mg / kg / day to about 12 mg / kg / day or from 2 mg / kg / day to about 6 mg / kg / day. In an aspect, a disclosed optimal dose of pazopanib and / or sorafenib can be about 3 mg / kg / day. In an aspect, dasatinib can be orally administered to a subject at a dose of from about 0.3 mg / kg / day to about 2.0 mg / kg / day or from about 0.7 mg / kg / day to about 1.4 mg / kg / day. In an aspect, a disclosed optimal dose of dasatinib can beabout 0.7 mg / kg / day. In an aspect, everolimus can be orally administered to a subject at a dose of from about 0.03 mg / kg / day to about 0. 15 mg / kg / day or from about 0.03 mg / kg / day to about 0.10 mg / kg / day. In an aspect, a disclosed optimal dose of everolimus can be about 0.07 mg / kg / day.

[0104] In an aspect, a disclosed pharmaceutical formulation comprising one or more antineoplastons can reduce and / or eliminate the number and / or type of genomic aberrations. For example, in an aspect, if a subject initially had X number of genomic aberrations, then following administration of a disclosed pharmaceutical formulation, the subject has some number of genomic aberrations less than X. In an aspect, a disclosed pharmaceutical formulation comprising one or more antineoplastons can prevent and / or decreases metastases. In an aspect, a disclosed pharmaceutical formulation comprising one or more antineoplastons can prolong the survival of a subject. In an aspect, a disclosed pharmaceutical formulation comprising one or more antineoplastons can improve the survivability of the subject. In an aspect, a disclosed pharmaceutical formulation comprising one or more antineoplastons can increase the subject's survivability, can increase the length of time before metastasis, can reduce the likelihood of surgical intervention, can reduce the need for administration of one or more additional therapeutic agents or regiments, can reduce the size of one or more tumors in the subject, eliminating one or more tumors in the subject, can reduce and / or eliminate the prevalence of one or more genomic aberrations, can restore the normal metabolism of one or more organ systems in the subject, can restore one or more aspect of cellular homeostasis and / or cellular functionality, and / or metabolic dysregulation; or any combination thereof.

[0105] In an aspect, disclosed pharmaceutical formulation comprising one or more antineoplastons can protect the subject from metastasis. In an aspect, disclosed pharmaceutical formulation comprising one or more antineoplastons can reduce the risk of developing metastasis.

[0106] In an aspect, restoring one or more aspects of cellular homeostasis and / or cellular functionality can comprise one or more of the following: (i) correcting cell starvation in one or more cell t pes (such as, for example, liver cells and muscle cells); (ii) normalizing aspects of the autophagy pathway (such as, for example, correcting, preventing, reducing, and / or ameliorating autophagy); (iii) improving, enhancing, restoring, and / or preserving mitochondrial functionality and / or structural integrity; (iv) improving, enhancing, restoring, and / or preserving organelle functionality and / or structural integrity; (v) preventing, slowing, and / or eliminating hypoglycemia, ketosis, and / or other liver abnormalities; (vi) correcting liver enzyme dysregulation; (vii) reversing, inhibiting, preventing, stabilizing, and / or slowing therate of progression of tumor metastasis; (viii) reversing, inhibiting, preventing, stabilizing, and / or slowing the rate of progression of tumor growth and / or cancer spread, or (ix) any combination thereof.

[0107] In an aspect, following the administering step, (i) the risk of developing metastases can be prevented and / or decreased; (ii) the survival of the subject can be prolonged; (iii) the subject's quality of life can be enhanced and / or improved; (iv) the likelihood of surgical intervention can be reduced and / or minimized; (v) preventing and / or delaying recurrence of the cancer; (vi) the size of one or more tumors in the subject can be reduced and / or decreased; (vii) one or more tumors in the subject can be eliminated; (viii) extending and / or prolonging disease-free or tumor-free survival time; (ix) increasing and / or lengthening overall survival time; (x) reducing and / or minimizing the frequency of treatment; (xi) relieving and / or ameliorating one or more symptoms of the cancer; (xii) reducing and / or decreasing tumor burden, (ix) preventing and / or facilitating surgical intervention; (xiii) normal metabolism of one or more organ systems in the subject can be improved and / or restored, (xiv) one or more aspects of cellular homeostasis and / or cellular functionality, and / or metabolic dysregulation; or any combination thereof.

[0108] In an aspect, restoring one or more aspects of cellular homeostasis can comprise improving, enhancing, restoring, and / or preserving one or more aspects of cellular structural and / or functional integrity in, for example, an organ or system that has been affected by cancer.

[0109] In an aspect, a disclosed pharmaceutical formulation comprising one or more antin eoplastons can comprise one or more chemotherapeutic agents. In an aspect, a disclosed chemotherapeutic agent can comprise an anthracy cline, a vinca alkaloid, an alkylating agent, an immune cell antibody, an antimetabolite, a TNFR glucocorticoid induced TNFR related protein (GITR) agonist, a proteasome inhibitor, an immunomodulator, or any combination thereof. In an aspect, a disclosed chemotherapeutic agent can comprise 5 -fluorouracil (AdruciL Efudex), 6-mercaptopurine (Purinethol), 6-thioguanine, aclarubicin or aclacinomycin A, alemtuzamab (Lemtrada), anastrozole (Arimidex), bicalutamide (Casodex), bleomycin sulfate (Blenoxane), bortezomib (Velcade), busulfan (Myleran), busulfan injection (Busulfex), capecitabine (Xeloda). carboplatin (Paraplatin), carmustine (BiCNU), chlorambucil (Leukeran), cisplatin (Platinol), cladribine (Leustatin), Cosmegan, cyclophosphamide (Cytoxan orNeosar), cyclophosphamide, cytarabine liposome injection (DepoCyt), cytarabine, cytosine arabinoside (Cytosar-U), dacarbazine (DTIC-Dome), dactinomycin (Cosmegen), daunorubicin citrate liposome injection (DaunoXome), daunorubicin hydrochloride (Cerubidine), dexamethasone, docetaxel (Taxotere), doxorubicin hydrochloride (Adriamycin,Rubex), etoposide (Vepesid), fludarabine phosphate (Fludara), flutamide (Eulexin), folic acid antagonists, gemcitabine (difluorodeoxycitidine), gemtuzumab, gliotoxin, hydroxyurea (Hydrea), Idarubicin (Idamycin), ifosfamide (IFEX), ifosfamide, irinotecan (Camptosar), L- asparaginase (ELSPAR), lenalidomide), leucovorin calcium, melphalan (Alkeran), melphalan, methotrexate (Folex), mitoxantrone (Novantrone), mylotarg, N4-pentoxycarbonyl-5 deoxy-5- fluorocytidine, nab-paclitaxel (Abraxane). paclitaxel (Taxol), pentostatin, phoenix (Yttrium90 / MX-DTPA). polifeprosan 20 with carmustine implant (Gliadel), purine analogs and adenosine deaminase inhibitors (fludarabine), pyrimidine analogs, rituximab, tamoxifen citrate (Nolvadex), temozolomide), teniposide (Vumon), tezacitibine, thalidomide or a thalidomide derivative, thiotepa, tirapazamine (Tirazone), topotecan hydrochloride for injection (Hy camptin), tositumomab), vinblastine (Velban), vinblastine, vincristine (Oncovin), vindesine, vinorelbine (Navelbine), or any combination thereof.

[0110] In an aspect, a disclosed pharmaceutical formulation comprising one or more antineoplastons can comprise an anti-chemokine therapy that enhances the resident memory T cell formations in tumor-free tissues. In an aspect, a disclosed anti-chemokine therapy can comprise one or more antibodies against CCL1, CCL2, CCL4, CCL17, CCL19. CCL21. CCL22, CCL25, CXCL9, CXCL10, CXCL11, CXCL12, CXCL13, CCR2, CCR5, CCR7, CCR8, CCR9, CXCR3, CXCR4, CXCR5, CX3CL1, CX3CR1, or any combination thereof.

[0111] In an aspect, a disclosed pharmaceutical formulation comprising one or more antineoplastons can be prepared for systemic or direct administration. In an aspect, a disclosed pharmaceutical formulation can be prepared for oral administration, intravenous administration, intratumoral administration, intraperitoneal administration, or any combination thereof. In an aspect, a disclosed pharmaceutical formulation can be prepared for any method of administration disclosed herein. In an aspect, a disclosed pharmaceutical formulation can be prepared for administration via multiple routes either concurrently or sequentially. For example, in an aspect, a disclosed pharmaceutical formulation can be first administered intratumorally and then be administered intravenously. In an aspect, a disclosed pharmaceutical formulation can be first administered intratumorally and then be administered orally. A skilled clinical can determine the best route of administration for a subject at a given time.

[0112] In an aspect, a disclosed pharmaceutical formulation comprising one or more disclosed antineoplastons can comprise (i) one or more active agents, (ii) biologically active agents, (iii) one or more pharmaceutically active agents, (iv) one or more immune-based therapeutic agents, (v) one or more clinically approved agents, or (vi) a combination thereof. In an aspect, adisclosed pharmaceutical formulation can comprise one or more immune modulators. In an aspect, a disclosed pharmaceutical formulation can comprise one or more proteasome inhibitors. In an aspect, a disclosed pharmaceutical formulation can comprise one or more immunosuppressives or immunosuppressive agents. In an aspect, an immunosuppressive agent can be anti-thymocyte globulin (ATG), cyclosporine (CSP), mycophenolate mofetil (MMF), or a combination thereof. In an aspect, a disclosed pharmaceutical formulation can comprise an anaplerotic agent (such as, for example, C7 compounds like triheptanoin or MCT).

[0113] In an aspect, a disclosed pharmaceutically acceptable carrier can comprise any disclosed carrier. In an aspect, a disclosed pharmaceutically acceptable carrier can comprise any disclosed excipient.

[0114] In an aspect, a disclosed pharmaceutical formulation can be packaged in unit dosage forms such as tablets, pills, capsules, powders, granules, solutions or suspensions, or suppositories, for oral, parenteral or rectal administration, or administration by inhalation or insufflation.

[0115] In an aspect, a disclosed pharmaceutical formulation can be used as a pan-tumor therapy. In an aspect, disclosed pharmaceutical formulation can be used to reducing viability of one or more cancer cells.

[0116] In an aspect, a disclosed pharmaceutical formulation can comprise antineoplastons formulated as capsules and / or tablets for oral administration. In an aspect, a disclosed pharmaceutical formulation can comprise antineoplastons formulated as a solution for intravenous administration. In an aspect, disclosed tablets / capsules can comprise about 100 mg to about 1000 mg of 3-phenylacetylamino-2, 6-piperidinedione. In an aspect, disclosed A10 tablets / capsules can comprise about 100 mg, about 200 mg, about 300 mg, about 400 mg, 500 mg, about 600 mg, about 700 mg, about 800 mg. about 900 mg, or about 1000 mg of 3- phenylacetylamino-2, 6-piperidinedione. In an aspect, disclosed A10 tablets / capsules can comprise about 500 mg of 3-phenylacetylamino-2, 6-piperidinedione. In an aspect, A10 can comprise a mixture of the sodium salts of PG and isoPG in a 4: 1 ratio for intravenous injection.

[0117] In an aspect, disclosed AS2-1 tablets / capsules can comprise about 100 mg to about 1000 mg of a 4: 1 PN and PG. In an aspect, disclosed AS2-1 tablets / capsules can comprise about 100 mg, about 200 mg, about 300 mg, about 400 mg, about 500 mg, about 600 mg, about 700 mg, about 800 mg, about 900 mg, or about 1000 mg. In an aspect, disclosed AS2-1 tablets / capsules can comprise about 500 mg of 3-phenylacetylamino-2, 6-piperidinedione. In an aspect, disclosed AS2-1 tablets / capsules can comprise about 500 mg of a 4: 1 PN and PG.In an aspect. AS2-1 can comprise a mixture of PN and PG in a 4: 1 ratio for intravenous injection.

[0118] In an aspect, a disclosed ANP can be formulated as pharmaceutically acceptable salt. In an aspect, pharmaceutically acceptable salts can include the acid addition and base addition salts thereof. In an aspect, a disclosed suitable acid addition salt can be formed from acids that form non- toxic salts. In an aspect, non-limiting examples of suitable acid addition salts (e.g., salts containing pharmacologically acceptable anions) can include, but are not limited to. the acetate, acid citrate, adipate, aspartate, benzoate, besylate, bicarbonate / carbonate, bisulphate / sulphate, bitartrate, borate, camsylate, citrate, cyclamate, edisylate, esylate, ethanesulfonate, formate, fumarate, gluceptate, gluconate, glucuronate, hexafluorophosphate, hibenzate, hydrochloride / chloride, hydrobromide / bromide, hydroiodide / iodide, isethionate, lactate, malate, maleate, mal onate, mesylate, methanesulfonate, methylsulphate, naphthylate, 2-napsylate, nicotinate, nitrate, orotate, oxalate, palmitate, pamoate, phosphate / hydrogen phosphate / dihydrogen phosphate, pyroglutamate, saccharate, stearate, succinate, tannate, tartrate, p-toluenesulfonate, tosylate. trill uoroacetate, and xinofoate salts.

[0119] In an aspect, a disclosed pharmaceutical formulation can comprise a disclosed pharmaceutically acceptable salt of a disclosed ANP and / or a disclosed targeted therapy and / or a disclosed anti-cancer agent.

[0120] In an aspect, a disclosed ANP can be used in connection with one or more targeted therapies for lung cancer or metastatic lung cancer.

[0121] In an aspect, a disclosed ANP can be used to treat and / or prevent cancer, to prolong the survival of the subject, to prevent and / or decrease metastases, to protect the subject from metastasis, to reduce the risk of developing metastases, to increase the subject's survivability, to increase the length of time before metastasis, to reduce the likelihood of surgical intervention, to reduce the need for administration of one or more additional therapeutic agents or regimens, to reduce the size of one or more tumors in the subject, to reduce the size of one or more tumors in one or more organs in the subject, to eliminate one or more tumors in the subject, to reduce and / or eliminate the prevalence of one or more genomic aberrations, to restore normal metabolism of one or more organ systems in the subject, to restore one or more aspects of cellular homeostasis, cellular functionality, and / or metabolic dysregulation in a subject, to reduce and / or inhibit aberrant angiogenesis and / or vasculogenesis in one or more tissues and / or organs of the subject, or any combination thereof.

[0122] n an aspect, a disclosed pharmaceutical formulation can be lyophilized prior to storage and / or can be stored as solution at ambient temperature or below ambient temperature. In anaspect, a disclosed pharmaceutical formulation can be frozen and / or can be stored frozen. In an aspect, a disclosed pharmaceutical formulation can be reconstituted and / or can be diluted in an infusion and / or stabilization solution prior to administration to a subject. In an aspect, a disclosed solution used for reconstitution or infusion and / or stabilization can contain any disclosed component or a similar disclosed component.

[0123] Disclosed herein are pharmaceutical compositions comprising one or more antineoplastons for the treatment of lung cancer and / or metastatic lung cancer. Disclosed herein are pharmaceutical compositions comprising one or more antineoplastons and one or more targeted therapies for the treatment of lung cancer and / or metastatic lung cancer. Disclosed herein are pharmaceutical compositions comprising one or more antineoplastons and one or more of abemaciclib, ado-trastuzumab emtansine, afatinib, alectinib. alemtuzumab, alpelisib, atezolizumab, avelumab, axitinib, bevacizumab, binimetinib, blinatumomab, bosutinib, brentuximab, brigatinib, cabozantinib, carfdzomib, cemiplimab, ceritinib, cetuximab, gilteritinib, cobimetinib, copanlisib, crizotinib, dabrafenib, dacomitinib, daratumumab, dasatinib, denosumab, dinutuximab, durvalumab, duvelisib, elotuzumab, encorafenib, entrectinib. erdafitinib, erlotinib, fam-trastuzumab deruxtecan-nxki, gefitinib. gemtuzumab, ibritumomab tiuxetan, ibrutinib, imatinib, inotuzumab, ipilumumab, ivosidenib, lapatinib, larotrectinib, Lenvatinib, lorlatinib, margetuximab-cmkb, necitumumab, neratinib, nilotinib, niraparib, nivolumab, obinutuzumab, ofatumumab, olaparib, olaratumab, osimertinib, palbociclib. panitumumab. pazopanib, pembrolizumab. pertuzumab. ponatinib, ramucirumab, regorafenib, ribociclib, rituximab, rucaparib, sorafenib, sunitinib, talazoparib, tivozanib, tositumomab, trametinib, trastuzumab, tucatinib, vandetanib, vemurafenib, vismodegib, or any combination thereof for the treatment of lung cancer and / or metastatic lung cancer. Disclosed herein are pharmaceutical compositions comprising one or more antineoplastons and one or more anti-cancer agents for the treatment of lung cancer and / or metastatic lung cancer. Disclosed herein are pharmaceutical compositions comprising one or more antineoplastons and one or more biosimilars for the treatment of lung cancer and / or metastatic lung cancer. Disclosed herein are pharmaceutical compositions comprising AS2-1 and / or A10 for the treatment of lung cancer and / or metastatic lung cancer. Disclosed herein are pharmaceutical compositions comprising AS2-1 and / or A10 and one or more targeted therapies for the treatment of lung cancer and / or metastatic lung cancer. Disclosed herein are pharmaceutical compositions comprising AS2-1 and / or A10 and one or more of abemaciclib, ado-trastuzumab emtansine, afatinib, alectinib, alemtuzumab, alpelisib, atezolizumab, avelumab, axitinib, bevacizumab, binimetinib, blinatumomab, bosutinib, brentuximab,brigatinib, cabozantinib, carfilzomib, cemiplimab, ceritinib, cetuximab, gilteritinib, cobimetinib, copanlisib, crizotinib, dabrafenib, dacomitinib, daratumumab, dasatinib, denosumab, dinutuximab, durvalumab, duvelisib, elotuzumab, encorafenib, entrectinib, erdafitinib, erlotinib, fam-trastuzumab deruxtecan-nxki, gefitinib, gemtuzumab, ibritumomab tiuxetan, ibrutinib, imatinib, inotuzumab, ipilumumab, ivosidenib, lapatinib, larotrectinib, Lenvatinib, lorlatinib, margetuximab-cmkb, necitumumab, neratinib, nilotinib. niraparib, nivolumab. obinutuzumab, ofatumumab, olaparib. olaratumab. osimertinib. palbociclib. panitumumab, pazopanib, pembrolizumab, pertuzumab, ponatinib, ramucirumab, regorafenib, ribociclib, rituximab, rucaparib, sorafenib, sunitinib, talazoparib, tivozanib, tositumomab, trametinib, trastuzumab, tucatinib, vandetanib, vemurafenib, vismodegib, or any combination thereof for the treatment of lung cancer and / or metastatic lung cancer. Disclosed herein are pharmaceutical compositions comprising AS2-1 and / or A10 and one or more one or more biosimilars for the treatment of lung cancer and / or metastatic lung cancer. Disclosed herein are pharmaceutical compositions comprising AS2-1 and / or A10 and one or more anti-cancer agents for the treatment of lung cancer and / or metastatic lung cancer.

[0124] Disclosed herein are pharmaceutical compositions for use in the treatment of lung cancer and / or metastatic lung cancer, the composition comprising one or more antineoplastons. Disclosed herein are pharmaceutical compositions for use in the treatment of lung cancer and / or metastatic lung cancer, the composition comprising one or more antineoplastons and one or more targeted therapies. Disclosed herein are pharmaceutical compositions for use in the treatment of lung cancer and / or metastatic lung cancer, the composition comprising one or more antineoplastons and one or more of abemaciclib, ado-trastuzumab emtansine, afatinib, alectinib, alemtuzumab, alpelisib, atezolizumab. avelumab, axitinib, bevacizumab, binimetinib, blinatumomab. bosutinib, brentuximab, brigatinib, cabozantinib, carfilzomib, cemiplimab, ceritinib, cetuximab, gilteritinib, cobimetinib, copanlisib, crizotinib, dabrafenib, dacomitinib, daratumumab, dasatinib, denosumab, dinutuximab, durvalumab, duvelisib, elotuzumab, encorafenib, entrectinib, erdafitinib, erlotinib, fam-trastuzumab deruxtecan-nxki, gefitinib, gemtuzumab, ibritumomab tiuxetan, ibrutinib, imatinib, inotuzumab, ipilumumab, ivosidenib. lapatinib. larotrectinib. Lenvatinib, lorlatinib, margetuximab-cmkb. necitumumab. neratinib, nilotinib, niraparib, nivolumab, obinutuzumab, ofatumumab, olaparib, olaratumab, osimertinib, palbociclib, panitumumab, pazopanib, pembrolizumab, pertuzumab, ponatinib, ramucirumab, regorafenib, ribociclib, rituximab, rucaparib, sorafenib, sunitinib, talazoparib, tivozanib, tositumomab, trametinib, trastuzumab, tucatinib, vandetanib. vemurafenib, vismodegib, or any combination thereof. Disclosed herein are pharmaceutical compositionsfor use in the treatment of lung cancer and / or metastatic lung cancer, the composition comprising one or more antineoplastons and one or more anti-cancer agents. Disclosed herein are pharmaceutical compositions for use in the treatment of lung cancer and / or metastatic lung cancer, the composition comprising one or more antineoplastons and one or more biosimilars. Disclosed herein are pharmaceutical compositions for use in the treatment of lung cancer and / or metastatic lung cancer, the composition comprising AS2-1 and / or A10. Disclosed herein are pharmaceutical compositions for use in the treatment of lung cancer and / or metastatic lung cancer, the composition comprising AS2-1 and / or A10 and one or more targeted therapies. Disclosed herein are pharmaceutical compositions for use in the treatment of lung cancer and / or metastatic lung cancer, the composition comprising AS2-1 and / or A10 and one or more of abemaciclib, ado-trastuzumab emtansine, afatinib, alectinib, alemtuzumab. alpelisib, atezolizumab, avelumab, axitinib, bevacizumab, binimetinib, blinatumomab, bosutinib, brentuximab, brigatinib, cabozantinib, carfilzomib, cemiplimab, ceritinib, cetuximab, gilteritinib, cobimetinib, copanlisib, crizotinib, dabrafenib, dacomitinib, daratumumab, dasatinib, denosumab, dinutuximab, durvalumab, duvelisib, elotuzumab, encorafenib, entrectinib. erdafitinib, erlotinib, fam-trastuzumab deruxtecan-nxki. gefitinib, gemtuzumab. ibritumomab tiuxetan, ibrutinib, imatinib, inotuzumab, ipilumumab, ivosidenib, lapatinib, larotrectinib, Lenvatinib, lorlatinib, margetuximab-cmkb, necitumumab, neratinib, nilotinib, niraparib, nivolumab. obinutuzumab, ofatumumab, olaparib, olaratumab, osimertinib, palbociclib, panitumumab. pazopanib. pembrolizumab. pertuzumab, ponatinib, ramucirumab, regorafenib, ribociclib, rituximab, rucaparib, sorafenib, sunitinib, talazoparib, tivozanib, tositumomab, trametinib. trastuzumab, tucatinib, vandetanib, vemurafenib, vismodegib, or any combination thereof. Disclosed herein are pharmaceutical compositions for use in the treatment of lung cancer and / or metastatic lung cancer, the composition comprising AS2-1 and / or A10 and one or more one or more biosimilars. Disclosed herein are pharmaceutical compositions for use in the treatment of lung cancer and / or metastatic lung cancer, the composition comprising AS2-1 and / or A10 and one or more anti-cancer agents.

[0125] Use of a disclosed pharmaceutical composition comprising one or more antineoplastons for the manufacture of a medicament for the treatment of lung cancer and / or metastatic lung cancer. Use of a disclosed pharmaceutical composition comprising one or more antineoplastons and one or more targeted therapies for the manufacture of a medicament for the treatment of lung cancer and / or metastatic lung cancer. Use of a disclosed pharmaceutical composition comprising one or more antineoplastons and one or more of abemaciclib. ado- trastuzumab emtansine, afatinib, alectinib, alemtuzumab, alpelisib, atezolizumab, avelumab,axitinib, bevacizumab, binimetinib, blinatumomab, bosutinib, brentuximab, brigatinib, cabozantinib, carfilzomib, cemiplimab. ceritinib, cetuximab, gilteritinib, cobimetinib, copanlisib, crizotinib, dabrafenib, dacomitinib, daratumumab, dasatinib, denosumab, dinutuximab, durvalumab, duvelisib, elotuzumab, encorafenib, entrectinib, erdafitinib, erlotinib, fam-trastuzumab deruxtecan-nxki, gefitinib, gemtuzumab, ibritumomab tiuxetan, ibrutinib. imatinib. inotuzumab, ipilumumab, ivosidenib. lapatinib, larotrectinib, Lenvatinib, lorlatinib, margetuximab-cmkb. necitumumab, neratinib. nilotinib, niraparib, nivolumab. obinutuzumab, ofatumumab, olaparib, olaratumab, osimertinib, palbociclib, panitumumab, pazopanib, pembrolizumab, pertuzumab, ponatinib, ramucirumab, regorafenib, ribociclib, rituximab, rucaparib, sorafenib, sunitinib, talazoparib, tivozanib, tositumomab, trametinib, trastuzumab, tucatinib. vandetanib, vemurafenib, vismodegib, or any combination thereof for the manufacture of a medicament for the treatment of lung cancer and / or metastatic lung cancer. Use of a disclosed pharmaceutical composition comprising one or more antineoplastons and one or more anti-cancer agents for the manufacture of a medicament for the treatment of lung cancer and / or metastatic lung cancer. Use of a disclosed pharmaceutical composition comprising one or more antineoplastons and one or more biosimilars for the manufacture of a medicament for the treatment of lung cancer and / or metastatic lung cancer. Use of a disclosed pharmaceutical composition comprising AS2-1 and / or A10 for the manufacture of a medicament for the treatment of lung cancer and / or metastatic lung cancer. Use of a disclosed pharmaceutical composition comprising AS2-1 and / or A10 and one or more targeted therapies for the manufacture of a medicament for the treatment of lung cancer and / or metastatic lung cancer. Use of a disclosed pharmaceutical composition comprising AS2-1 and / or A10 and one or more of abemaciclib, ado-trastuzumab emtansine, afatinib, alectinib, alemtuzumab, alpelisib, atezolizumab, avelumab, axitinib, bevacizumab, binimetinib, blinatumomab, bosutinib, brentuximab, brigatinib, cabozantinib, carfilzomib, cemiplimab, ceritinib, cetuximab, gilteritinib, cobimetinib, copanlisib, crizotinib, dabrafenib, dacomitinib, daratumumab, dasatinib, denosumab, dinutuximab, durvalumab. duvelisib, elotuzumab, encorafenib, entrectinib, erdafitinib, erlotinib, fam-trastuzumab deruxtecan-nxki, gefitinib, gemtuzumab, ibritumomab tiuxetan. ibrutinib. imatinib. inotuzumab. ipilumumab. ivosidenib. lapatinib, larotrectinib, Lenvatinib, lorlatinib, margetuximab-cmkb, necitumumab, neratinib, nilotinib, niraparib, nivolumab, obinutuzumab, ofatumumab, olaparib, olaratumab, osimertinib, palbociclib, panitumumab, pazopanib, pembrolizumab. pertuzumab, ponatinib, ramucirumab, regorafenib, ribociclib. rituximab, rucaparib, sorafenib, sunitinib, talazoparib, tivozanib, tositumomab, trametinib, trastuzumab, tucatinib, vandetanib, vemurafenib,vismodegib, or any combination thereof for the manufacture of a medicament for the treatment of lung cancer and / or metastatic lung cancer. Use of a disclosed pharmaceutical composition comprising AS2-1 and / or A10 and one or more one or more biosimilars for the manufacture of a medicament for the treatment of lung cancer and / or metastatic lung cancer. Use of a disclosed pharmaceutical composition comprising AS2-1 and / or A10 and one or more anti-cancer agents for the manufacture of a medicament for the treatment of lung cancer and / or metastatic lung cancer.

[0126] A disclosed pharmaceutical composition comprising one or more antineoplastons for use in the treatment of lung cancer and / or metastatic lung cancer. A disclosed pharmaceutical composition comprising one or more antineoplastons and one or more targeted therapies for use in the treatment of lung cancer and / or metastatic lung cancer.

[0127] A disclosed pharmaceutical composition comprising one or more antineoplastons and one or more of abemaciclib, ado-trastuzumab emtansine, afatinib, alectinib, alemtuzumab, alpelisib, atezolizumab. avelumab, axitinib, bevacizumab, binimetinib, blinatumomab, bosutinib, brentuximab, brigatinib, cabozantinib. carfilzomib, cemiplimab. ceritinib, cetuximab, gilteritinib. cobimetimb. copanhsib, crizotinib. dabrafenib. dacomitinib. daratumumab, dasatinib, denosumab, dinutuximab, durvalumab, duvelisib, elotuzumab, encorafenib, entrectinib. erdafitinib, erlotinib, fam-trastuzumab deruxtecan-nxki, gefitinib, gemtuzumab, ibritumomab tiuxetan. ibrutinib, imatinib. inotuzumab, ipilumumab, ivosidenib, lapatinib. larotrectinib, Lenvatinib, lorlatinib. margetuximab-cmkb, necitumumab, neratinib, nilotinib, niraparib, nivolumab, obinutuzumab, ofatumumab, olaparib, olaratumab, osimertinib, palbociclib, panitumumab, pazopanib, pembrolizumab, pertuzumab, ponatinib, ramucirumab, regorafenib, ribociclib, rituximab, rucaparib, sorafenib, sunitinib, talazoparib, tivozanib, tositumomab, trametinib, trastuzumab, tucatinib, vandetanib, vemurafenib, vismodegib, or any combination thereof for use in the treatment of lung cancer and / or metastatic lung cancer.

[0128] A disclosed pharmaceutical composition comprising one or more antineoplastons and one or more anti-cancer agents for use in the treatment of lung cancer and / or metastatic lung cancer. A disclosed pharmaceutical composition comprising one or more antineoplastons and one or more biosimilars for use in the treatment of lung cancer and / or metastatic lung cancer. A disclosed pharmaceutical composition comprising AS2-1 and / or Al 0 for use in the treatment of lung cancer and / or metastatic lung cancer. A disclosed pharmaceutical composition comprising AS2-1 and / or A10 and one or more targeted therapies for use in the treatment of lung cancer and / or metastatic lung cancer. A disclosed pharmaceutical compositioncomprising AS2-1 and / or A10 and one or more of abemaciclib, ado-trastuzumab emtansine, afatinib, alectinib, alemtuzumab, alpelisib, atezolizumab, avelumab, axitinib, bevacizumab, binimetinib, blinatumomab, bosutinib, brentuximab, brigatinib, cabozantinib, carfilzomib, cemiplimab, ceritinib, cetuximab, gilteritinib, cobimetinib, copanlisib, crizotinib, dabrafenib, dacomitinib, daratumumab, dasatinib, denosumab, dinutuximab, durvalumab, duvelisib, elotuzumab, encorafenib, entrectinib, erdafitinib, erlotinib, fam-trastuzumab deruxtecan-nxki, gefitinib. gemtuzumab, ibritumomab tiuxetan, ibrutinib, imatinib. inotuzumab, ipilumumab. ivosidenib, lapatinib, larotrectinib, Lenvatinib, lorlatinib, margetuximab-cmkb, necitumumab, neratinib, nilotinib, niraparib, nivolumab, obinutuzumab, ofatumumab, olaparib, olaratumab, osimertinib, palbociclib, panitumumab, pazopanib, pembrolizumab. pertuzumab, ponatinib, ramucirumab, regorafenib, ribociclib. rituximab, rucaparib, sorafenib, sunitinib, talazoparib, tivozanib, tositumomab, trametinib, trastuzumab, tucatinib, vandetanib, vemurafenib, vismodegib, or any combination thereof for use in the treatment of lung cancer and / or metastatic lung cancer. A disclosed pharmaceutical composition comprising AS2-1 and / or A10 and one or more one or more biosimilars for use in the treatment of lung cancer and / or metastatic lung cancer. A disclosed pharmaceutical composition comprising AS2-1 and / or Al 0 and one or more anti-cancer agents for use in the treatment of lung cancer and / or metastatic lung cancer.

[0129] In an aspect, a disclosed biosimilar can comprise an FDA approved biosimilar (e.g., Bkemv (eculizumab-aeeb), Yesafili (aflibercept-jbvf). Opuviz (aflibercept-yszy), Hercessi (trastuzumab-strf), Selarsdi (ustekinumab-aekn), Tyenne (tocilizumab-aazg), Jubbonti (denosumab-bbdz), Wyost (denosumab-bbdz), Simlandi (adalimumab-ryvk), Avzivi (bevacizumab-tnjn), Wezlana (ustekinumab-auub), Tofidence (tocilizumab-bavi), Tyruko (natalizumab-sztn), Yuflyma (adalimumab-aaly). Idacio (adalimumab-aacf), Vegzelma (bevacizumab-adcd), Stimufend (pegfilgrastim-fpgk), Cimerli (ranibizumab-eqm), Fylnetra (pegfilgrastim-pbbk), Alymsys (bevacizumab-maly), Releuko (filgrastim-ayow), Yusimry (adalimumab-aqvh), Rezvoglar (insulin glargine-aglr), Byooviz (ranibizumab-nuna), Semglee (insulin glargine-yfgn). Riabni (rituximab-arrx), Hulio (adalimumab-fkjp), Nyvepria (pegfilgrastim-apgf). Avsola (infliximab-axxq). Abrilada (adalimumab-afzb), Ziextenzo (pegfilgrastim-bmez), Hadlima (adalimumab-bwwd), Ruxience (rituximab-pvvr), Zirabev (bevacizumab-bvzr), Kanjinti (trastuzumab-anns), Eticovo (etanercept-ykro), Trazimera (trastuzumab-qyyp), Ontruzant (trastuzumab-dttb), Herzuma (trastuzumab-pkrb), Truxima (rituximab-abbs), Udenyca (pegfilgrastim-cbqv), Hyrimoz (adalimumab-adaz). Nivestym (filgrastim-aafi), Fulphila (pegfilgrastim-jmdb), Retacrit (epoetin alfa-epbx), Ixifi (infliximab-qbtx), Ogivri (trastuzumab-dkst), Mvasi (bevacizumab-awwb), Cyltezo (adalimumab-adbm), Renflexis (infliximab-abda). Amj evita (adalimumab-atto), Erelzi (etanercept-szzs). Inflectra (infliximab-dyyb), Zarxio (filgrastim-sndz), or any combination thereof.3. Kits

[0130] Disclosed herein is a kit comprising one or more disclosed antineoplastons and one or more targeted therapies. Disclosed herein is a kit comprising one or more disclosed antineoplastons and one or more targeted therapies, wherein the antineoplastons and the targeted therapies are used to treat a subject having one or more cancers. Disclosed herein is a kit comprising one or more disclosed antineoplastons and one or more targeted therapies, wherein the antineoplastons and the targeted therapies are used to treat a subject having lung cancer or metastatic lung cancer.

[0131] Disclosed herein is a kit comprising a disclosed pharmaceutical formulation comprising one or more antineoplastons and one or more targeted therapies. Disclosed herein is a kit comprising a disclosed pharmaceutical formulation comprising one or more antineoplastons and one or more targeted therapies, wherein the pharmaceutical formulation comprising one or more antineoplastons and the targeted therapies are used to treat a subject having one or more cancers. Disclosed herein is a kit comprising a disclosed antineoplastons and one or more targeted therapies, wherein the pharmaceutical formulation comprising one or more antineoplastons and the targeted therapies are used to treat a subject having lung cancer or metastatic lung cancer.

[0132] Disclosed herein is a kit comprising one or more disclosed antineoplastons and one or more targeted therapies for one or more treatment cycles. Disclosed herein is a kit comprising one or more disclosed antineoplastons and one or more targeted therapies, wherein the antineoplastons and the targeted therapies are used to treat a subject having one or more cancers for one or more treatment cycles. Disclosed herein is a kit comprising one or more disclosed antineoplastons and one or more targeted therapies, wherein the antineoplastons and the targeted therapies are used to treat a subject having lung cancer or metastatic lung cancer for one or more treatment cycles. Disclosed herein is a kit comprising a disclosed pharmaceutical formulation comprising one or more antineoplastons and one or more targeted therapies for one or more treatment cycles. Disclosed herein is a kit comprising a disclosed pharmaceutical formulation comprising one or more antineoplastons and one or more targeted therapies, wherein the pharmaceutical formulation comprising one or more antineoplastons and the targeted therapies are used to treat a subject having one or more cancers for one or more treatment cycles. Disclosed herein is a kit comprising a disclosed antineoplastons and one ormore targeted therapies, wherein the pharmaceutical formulation comprising one or more antineoplastons and the targeted therapies are used to treat a subject having lung cancer or metastatic lung cancer for one or more treatment cycles.

[0133] In an aspect, a disclosed kit can be used to treat and / or prevent cancer, to prolong the survival, preventing and / or decreasing metastases, to protect the subject from metastasis, to reduce the risk of developing metastases, to increase the subject's survivability, to increase the length of time before metastasis, to reduce the likelihood of surgical intervention, to reduce the need for administration of one or more additional therapeutic agents or regimens, to reduce the size of one or more tumors in the subject, to reduce the size of one or more tumors in one or more organs in the subject, to eliminate one or more tumors in the subject, to reduce and / or eliminate the prevalence of one or more genomic aberrations, to restore normal metabolism of one or more organ systems in the subject, to restore one or more aspects of cellular homeostasis, cellular functionality, and / or metabolic dysregulation in a subject, to reduce and / or inhibit aberrant angiogenesis and / or vasculogenesis in one or more tissues and / or organs of the subject, or any combination thereof. In an aspect, a disclosed ANP therapy can be used as a pan-tumor therapy.

[0134] In an aspect, a disclosed therapeutic agent can treat, prevent, inhibit, and / or ameliorate one or more comorbidities in a subject. In an aspect, one or more active agents can treat, inhibit, prevent, and / or ameliorate cellular and / or metabolic complications related to cancer or cancer cells or cancerous cells (such as lung cancer, lung cancer cells, or lung cancerous cells).

[0135] In an aspect, a disclosed kit can be used to treat and / or prevent cancer, to prolong the survival, preventing and / or decreasing metastases, to protect the subject from metastasis, to reduce the risk of developing metastases, to increase the subject's survivability, to increase the length of time before metastasis, to reduce the likelihood of surgical intervention, to reduce the need for administration of one or more additional therapeutic agents or regimens, to reduce the size of one or more tumors in the subject, to reduce the size of one or more tumors in one or more organs in the subject, to eliminate one or more tumors in the subject, to reduce and / or eliminate the prevalence of one or more genomic aberrations, to restore normal metabolism of one or more organ systems in the subject, to restore one or more aspects of cellular homeostasis, cellular functionality, and / or metabolic dysregulation in a subject, to reduce and / or inhibit aberrant angiogenesis and / or vasculogenesis in one or more tissues and / or organs of the subject, or any combination thereof. In an aspect, a disclosed kit can be used as a pan- tumor therapy. In an aspect, a disclosed kit comprising a disclosed ANP and / or a disclosed pharmaceutical formulation can be used to reducing viability of one or more cancer cells.

[0136] In an aspect, a disclosed kit can be used such that (i) the risk of developing metastases can be prevented and / or decreased; (ii) the survival of the subject can be prolonged; (iii) the subject's quality of life can be enhanced and / or improved; (iv) the likelihood of surgical intervention can be reduced and / or minimized; (v) preventing and / or delaying recurrence of the cancer; (vi) the size of one or more tumors in the subject can be reduced and / or decreased; (vii) one or more tumors in the subject can be eliminated; (viii) extending and / or prolonging disease-free or tumor-free survival time; (ix) increasing and / or lengthening overall survival time; (x) reducing and / or minimizing the frequency of treatment; (xi) relieving and / or ameliorating one or more symptoms of the cancer; (xii) reducing and / or decreasing tumor burden, (ix) preventing and / or facilitating surgical intervention; (xiii) normal metabolism of one or more organ systems in the subject can be improved and / or restored, (xiv) one or more aspects of cellular homeostasis and / or cellular functionality, and / or metabolic dysregulation can be restored and / or improved, or (xv) any combination thereof.

[0137] In an aspect, a disclosed kit can comprise one or more additional and / or therapeutic agents. "Agents" and "Therapeutic Agents" are known to the art and are described herein. In an aspect, a disclosed agent or a disclosed therapeutic agent can comprise one or more monoclonal antibodies, one or more antibody-drug conjugates, one or more kinase inhibitors, one or more CDK4 and / or CDK6 inhibitors, one or more mTOR inhibitors, one or more ADK inhibitors, one or more PI3K inhibitors, one or more PARP inhibitors, or any combination thereof.

[0138] In an aspect, a disclosed kit can comprise a disclosed chemotherapeutic agent. In an aspect, a disclosed chemotherapeutic agent can comprise anthracycline-based chemotherapy or can comprise non-anthracycline-based chemotherapy. In an aspect, a disclosed chemotherapeutic agent can comprise oxaliplatin, doxorubicin, daunorubicin, docetaxel, mitoxanthrone, paclitaxel, digitoxin, digoxin, septacidin, 5 -fluorouracil and epirubicin, doxorubicin and cyclophosphamide, epirubicin and cyclophosphamide, docetaxel and carboplatin, or any combination thereof. In an aspect, a disclosed chemotherapeutic agent can be formulated as a polymeric micelle formulation, a liposomal formulation, a dendrimer formulation, a polymer-based nanoparticle formulation, a silica-based nanoparticle formulation, a nanoscale coordination polymer formulation, an inorganic nanoparticle formulation, or any combination thereof.

[0139] In an aspect, a disclosed kit can comprise targeted immunotherapy agent (e.g., fam- trastuzumab-deruxtecan-nxki; trastuzumab; Herceptin Hylecta (injectable Herceptin); Herceptin biosimilars (e.g., Herzuma, Kanjinti, Ogivri, Ontruzant, and Trazimera); ado-trastuzumab emtansine; margetuximab-cmkb; pertuzumab. trastuzumab, and hyaluronidase- zzxf; pertuzumab; sacituzumab govitecan-hziy; or any combination thereof).

[0140] In an aspect, a disclosed antineoplaston can comprise capsules and / or tablets for oral administration. In an aspect, a disclosed antineoplaston can comprise a solution for intravenous administration.

[0141] In an aspect, disclosed A10 tablets / capsules can comprise about 100 mg to about 1000 mg of 3-phenylacetylamino-2. 6-piperidinedione. In an aspect, disclosed A10 tablets / capsules can comprise about 100 mg, about 200 mg, about 300 mg, about 400 mg, 500 mg, about 600 mg, about 700 mg, about 800 mg, about 900 mg, or about 1000 mg of 3-phenylacetylamino-2, 6-piperidinedione. In an aspect, disclosed A10 tablets / capsules can comprise about 500 mg of 3-phenylacetylamino-2, 6-piperidinedione. In an aspect, disclosed A10 can comprise a mixture of the sodium salts of PG and iso-PG in a 4: 1 ratio for intravenous injection.

[0142] In an aspect, disclosed AS2-1 tablets / capsules can comprise about 100 mg to about 1000 mg of a 4: 1 PN and PG. In an aspect, disclosed AS2-1 tablets / capsules can comprise about 100 mg, about 200 mg, about 300 mg, about 400 mg, about 500 mg. about 600 mg, about 700 mg, about 800 mg. about 900 mg, or about 1000 mg. In an aspect, disclosed AS2-1 tablets / capsules can comprise about 500 mg of 3-phenylacetj lamino-2, 6-piperidinedione. In an aspect, disclosed AS2-1 tablets / capsules can comprise about 500 mg of a 4: 1 PN and PG. In an aspect, AS2-1 can comprise a mixture of PN and PG in a 4: 1 ratio for intravenous injection.

[0143] In an aspect, a disclosed kit can comprise one or more targeted therapies. In an aspect, a disclosed targeted therapy can be a commercially available targeted therapy. In an aspect, a disclosed targeted therapy can be an experimental targeted therapy.

[0144] In an aspect, a disclosed targeted therapy can comprise abagovomab; abciximab; abituzumab; abrilumab; actoxumab; adalimumab; adecatumumab; aducanumab; afelimomab; afutuzumab; alacizumab pegol; alemtuzumab; alirocumab; altumomab pentetate; amatuximab; anatumomab mafenatox; anetumab ravtansine; anifrolumab; anrukinzumab; apolizumab; arcitumomab; ascrinvacumab; aselizumab; atezolizumab; atinumab; atlizumab (tocilizumab); atorolimumab; bapineuzumab; basiliximab; bavituximab; bectumomab; begelomab; belimumab; benralizumab; bertilimumab; besilesomab; bevacizumab; bezlotoxumab; biciromab; bimagrumab; bimekizumab; bivatuzumab mertansine; blinatumomab; blosozumab; bococizumab; brentuxim abvedotin: briakinumab; brodalumab; brolucizumab; brontictuzumab; canakinumab; cantuzumab mertansine; cantuzumab ravtansine; caplacizumab; capromab pendetide; carlumab; catumaxomab; cbr96-doxorubicinimmunoconjugate; cedelizumab; certolizumab pegol; cetuximab; citatuzumab bogatox; cixutumumab; clazakizumab; clenoliximab; clivatuzumab tetraxetan; codrituzumab; coltuximab ravtansine; conatumumab; concizumab; crenezumab; dacetuzumab; daclizumab; dalotuzumab; dapirolizumab pegol; daratumumab; dectrekumab; demcizumab; denintuzumab mafodotin; denosumab; derlotuximab biotin; detumomab; dinutuximab; diridavumab; dorlimomab aritox: drozitumab; duligotumab; dupilumab; durvalumab; dusigitumab; ecromeximab; eculizumab; edobacomab; edrecolomab; efalizumab; efungumab; eldelumab; elgemtumab; elotuzumab; elsilimomab; emactuzumab; emibetuzumab; enavatuzumab; enfortumab vedotin; enlimomab pegol; enoblituzumab; enokizumab; enoticumab; ensituximab; epitumomab cituxetan; epratuzumab; erlizumab: ertumaxomab; etanercept; etaracizumab; etrolizumab; evinacumab; evolocumab; exbivirumab; fanolesomab; faralimomab; farletuzumab; fasinumab; felvizumab; fezakinumab; ficlatuzumab; figitumumab; firivumab; flanvotumab; fletikumab; fbntolizumab; foralumab; foravirumab; fresolimumab; fulranumab; futuximab; galiximab; ganitumab; gantenerumab; gavilimomab; gemtuzumab ozogamicin; gevokizumab; girentuximab; glembatumumab vedotin; golimumab; gomiliximab; guselkumab; ibalizumab; ibritumomab tiuxetan; icrucumab; idarucizumab; igovomab; imalumab; imciromab; imgatuzumab; inclacumab; indatuximab ravtansine; indusatumab vedotin; infliximab; inolimomab; inotuzumab ozogamicin; intetumumab; ipilimumab; iratumumab; isatuximab; itolizumab; ixekizumab; keliximab; labetuzumab; lambrolizumab; lampalizumab; lebrikizumab; lemalesomab; lenzilumab; lerdelimumab; lexatumumab; libivirumab; lifastuzumab vedotin; ligelizumab; lilotomab satetraxetan; lintuzumab; lirilumab; lodelcizumab; lokivetmab; lorvotuzumab mertansine; lucatumumab; lulizumab pegol: lumiliximab; lumretuzumab; mapatumumab; margetuximab; maslimomab; matuzumab; mavrilimumab; mepolizumab; metelimumab; milatuzumab; minretumomab; mirvetuximab soravtansine; mitumomab; mogamulizumab; morolimumab; motavizumab; moxetumomab pasudotox; muromonab-cd3; nacolomab tafenatox; namilumab; naptumomab estafenatox; namatumab; natalizumab; nebacumab; necitumumab; nemolizumab; nerelimomab; nesvacumab; nimotuzumab; nivolumab; nofetumomab merpentan; obiltoxaximab; obinutuzumab; ocaratuzumab; ocrelizumab; odulimomab; ofatumumab; olaratumab; olokizumab; omalizumab; onartuzumab; ontuxizumab; opicinumab; oportuzumab monatox; oregovomab; orticumab; otelixizumab; otlertuzumab; oxelumab; ozanezumab; ozoralizumab; pagibaximab; palivizumab; panitumumab; pankomab; panobacumab; parsatuzumab; pascolizumab; pasotuxizumab; pateclizumab; patritumab; pembrolizumab; pemtumomab; perakizumab; pertuzumab; pexelizumab; pidilizumab; pinatuzumab vedotin;pintumomab: placulumab; polatuzumab vedotin; ponezumab; pralsetinib; priliximab; pritoxaximab; pritumumab; quilizumab; racotumomab; radretumab; rafivirumab; ralpancizumab; ramucirumab; ranibizumab; raxibacumab; refanezumab; regavirumab; reslizumab; rilotumumab; rinucumab; rituximab; robatumumab; roledumab; romosozumab; rontalizumab; rovelizumab; ruplizumab; sacituzumab govitecan; samalizumab; sarilumab; satumomab pendetide; secukinumab; seribantumab; setoxaximab; sevirumab; sibrotuzumab; sifalimumab; siltuximab; simtuzumab; siplizumab; sirukumab; sofituzumab vedotin; solanezumab; solitomab; sonepcizumab; sontuzumab; stamulumab; sulesomab; suvizumab; tabalumab; tacatuzumab tetraxetan; tadocizumab; talizumab; tanezumab; taplitumomab paptox: tarextumab; tefibazumab; telimomab aritox; tenatumomab; teneliximab; teplizumab; teprotumumab: tesidolumab; tetulomab; ticilimumab; tigatuzumab; tildrakizumab; tocilizumab; toralizumab; tosatoxumab; tositumomab; tovetumab; tralokinumab; trastuzumab; tregalizumab; tremelimumab; trevogrumab; tucotuzumab celmoleukin; tuvirumab; ublituximab; ulocuplumab; urelumab; urtoxazumab; ustekinumab; vandortuzumab vedotin; vantictumab; vanucizumab; vapaliximab; varlilumab; vatelizumab; vedolizumab; veltuzumab; vepalimomab; vesencumab; visilizumab; volociximab; vorsetuzumab mafodotin; votumumab; zalutumumab; zanolimumab; zatuximab; ziralimumab; zolimomab aritox, or any combination thereof.

[0145] In an aspect, a disclosed targeted therapy can comprise abemaciclib, ado-trastuzumab emtansine, afatinib, alectinib. alemtuzumab. alpelisib, atezolizumab. avelumab. axitinib, bevacizumab, binimetinib, blinatumomab, bosutinib, brentuximab, brigatinib, cabozantinib, carfilzomib, cemiplimab, ceritinib, cetuximab, cgilteritinib, cobimetinib, copanlisib, crizotinib, dabrafenib, dacomitinib, daratumumab, dasatinib. denosumab, dinutuximab, durvalumab, duvelisib, elotuzumab, encorafenib. entrectinib, erdafitinib, erlotinib, fam-trastuzumab deruxtecan-nxki, gefitinib, gemtuzumab, ibritumomab, ibrutinib, imatinib, inotuzumab, ipilumumab, ivosidenib, lapatinib, larotrectinib, lenvatinib, lorlatinib, margetuximab-cmkb, marizomib, necitumumab, neratinib, nilotinib, niraparib, nivolumab, obinutuzumab, ofatumumab. olaparib, olaratumab, osimertinib, palbociclib, panitumumab, pazopanib, pembrolizumab, pertuzumab. ponatinib, pralsetinib. ramucirumab. regorafenib. ribociclib. rituximab, rucaparib, sorafenib, sunitinib, talazoparib, tositumomab, trametinib, trastuzumab, tucatinib, vandetanib, vemurafenib, vismodegib, or any combination thereof.

[0146] In an aspect, a disclosed targeted therapy can comprise abemaciclib, ado-trastuzumab emtansine, afatinib, alectinib, alemtuzumab, alpelisib, atezolizumab, avelumab, axitinib, bevacizumab, binimetinib, blinatumomab, bosutinib, brentuximab, brigatinib, cabozantinib,carfilzomib, cemiplimab, ceritinib, cetuximab, gilteritinib, cobimetinib, copanlisib, crizotinib, dabrafenib. dacomitinib, daratumumab, dasatinib. denosumab. dinutuximab, durvalumab, duvelisib, elotuzumab, encorafenib, entrectinib, erdafitinib, erlotinib, fam-trastuzumab deruxtecan-nxki, gefitinib, gemtuzumab, ibritumomab, ibrutinib, imatinib, inotuzumab, ipilumumab, ivosidenib, lapatinib, larotrectinib, lenvatinib, lorlatinib, margetuximab-cmkb, marizomib, necitumumab, neratinib, nilotinib, niraparib, nivolumab, obinutuzumab, ofatumumab. olaparib, olaratumab, osimertinib. palbociclib. panitumumab, pazopanib. pembrolizumab, pertuzumab, ponatinib, pralsetinib, ramucirumab, regorafenib, ribociclib, rituximab, rucaparib, sorafenib, sunitinib, talazoparib, tositumomab, trametinib, trastuzumab, tucatinib. vandetanib, vemurafenib, vismodegib, or any combination thereof.

[0147] For example, in an aspect, a disclosed kit can comprise (i) one or more ANPs for intravenous administration, and (ii) one or more targeted therapies for oral administration.

[0148] In an aspect, a disclosed targeted therapy for oral administration can comprise abemaciclib, afatinib, alectinib, alpelisib, axitinib, binimetinib, bosutinib, brigatinib, cabozantinib, cobimetinib, crizotinib, dabrafenib, dacomitinib, dasatinib, duvelisib, encorafenib, entrectinib, erdafitinib. erlotinib, gefitinib, gilteritinib. ibrutinib, imatinib mesylate, ivosidenib, lapatinib, larotrectinib, lorlatinib, lenvatinb, neratinib, nilotinib, niraparib, olaparib, osimertinib palbociclib, pazopanib, ponatinib, pralsetinib, regorafenib, ribociclib, rucaparib, sorafenib, sunitinib malate, talazoparib, tivozanib. trametinib, vandetanib, vemurafenib, vismodegib. or any combination thereof.

[0149] For example, in an aspect, a disclosed kit can comprise (i) one or more ANPs for intravenous administration, and (ii) one or more targeted therapies for intravenous administration.

[0150] In an aspect, a disclosed targeted therapy for intravenous administration can comprise ado-trastuzumab emtansine, alemtuzumab, atezolizumab, avelumab, bevacizumab, blinatumomab, brentuximab vedotin, carfilzomib, cetuximab, cemiplimab-rwlc, certinib, copanlisib, daratumumab, dinutuximab, durvalumab, elotuzumab, fam-trastuzumab deruxtecan-nxki, gemtuzumab ozogamicin. ibritumomab tiuxetan, inotuzumab ozogamicin, ipilimumab, margetuximab-cmkb, necitumumab, nivolumab, obinutuzumab. olaratumab. panitumumab, pembrolizumab, pertuzumab, ramucirumab, rituximab, tositumomab and iodine 1131 tositumomab, trastuzumab, ublituximab-xiiy, or any combination thereof.

[0151] For example, in an aspect, a disclosed kit can comprise (i) one or more ANPs for intravenous administration, and (ii) one or more targeted therapies for subcutaneous administration. In an aspect, a disclosed targeted therapy for subcutaneous administration cancomprise denosumab, ofatumumab, or any combination thereof. For example, in an aspect, a disclosed kit can comprise (i) one or more ANPs for intravenous administration, and (ii) one or more targeted therapies for oral administration, for intravenous administration, for subcutaneous administration, or any combination thereof.

[0152] In an aspect, a disclosed kit can comprise one or more doses of a disclosed treatment regimen, a disclosed antineoplaston, a disclosed targeted therapy, a disclosed pharmaceutical formulation, a disclosed anti-chemokine, a disclosed anti-cancer agent, a disclosed chemotherapeutic agent, or the combination thereof. In an aspect, a disclosed kit can comprise one or more cycles of a disclosed treatment regimen, a disclosed antineoplaston, a disclosed targeted therapy, a disclosed pharmaceutical formulation, a disclosed anti-chemokine, a disclosed anti-cancer agent, a disclosed chemotherapeutic agent, or the combination thereof.

[0153] In an aspect, a disclosed kit can comprise at least two components constituting the kit. Together, the components constitute a functional unit for a given purpose (such as, for example, treating a subject diagnosed with or suspected of having a disease or disorder such as lung cancer). Individual member components may be physically packaged together or separately. For example, a kit comprising an instruction for using the kit may or may not physically include the instruction with other individual member components. Instead, the instruction can be supplied as a separate member component, either in a paper form or an electronic form which may be supplied on computer readable memory device or downloaded from an internet website, or as recorded presentation.

[0154] In an aspect, a disclosed kit for use in a disclosed method can comprise one or more containers holding a disclosed treatment regimen, a disclosed antineoplaston, a disclosed targeted therapy, a disclosed pharmaceutical formulation, a disclosed anti-chemokine, a disclosed anti-cancer agent, a disclosed chemotherapeutic agent, or a combination thereof, and a label or package insert with instructions for use. In an aspect, suitable containers include, for example, bottles, vials, syringes, blister pack, etc. The containers can be formed from a variety of materials such as glass or plastic. The container can hold one or more disclosed antineoplastons, one or more disclosed pharmaceutical formulations comprising one or more disclosed antineoplastons, or any combination thereof, and can have a sterile access port (for example the container may be an intravenous solution bag or a vial having a stopper pierceable by a hypodermic injection needle). The label or package insert can indicate one or more disclosed antineoplastons, disclosed pharmaceutical formulations, or any combination thereof can be used for treating, preventing, inhibiting, and / or ameliorating a disease or disorder or complications and / or symptoms associated with cancer or metastatic cancer (e.g., lung canceror metastatic lung cancer). A kit can comprise additional components necessary' for administration such as. for example, other buffers, diluents, filters, needles, and syringes.D. Methods of Treating Cancer

[0155] Disclosed herein is a method for treating lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising a therapeutically effective amount of one or more antineoplastons or a pharmaceutical formulation thereof, and a therapeutically effective amount of one or more targeted therapies.

[0156] Disclosed herein is a method for treating lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising precision cancer treatment comprising a therapeutically effective amount of one or more antineoplastons, and a therapeutically effective amount of one or more targeted therapies.

[0157] Disclosed herein is a method for treating lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising a therapeutically effective amount of AS2-1 and / or A10, and a therapeutically effective amount of one or more targeted therapies.

[0158] Disclosed herein is a method for treating lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising precision cancer treatment comprising a therapeutically effective amount of AS2-1 and / or A10, and a therapeutically effective amount of one or more targeted therapies.

[0159] Disclosed herein is a method for treating lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising a therapeutically effective amount of AS2-1 and / or A10, and a therapeutically effective amount of one or more targeted therapies, wherein the one or more targeted therapies comprise abemaciclib, ado- trastuzumab emtansine, afatinib, alectinib, alemtuzumab, alpelisib, atezolizumab. avelumab, axitinib, bevacizumab, binimetinib, blinatumomab, bosutinib, brentuximab, brigatinib, cabozantinib, carfdzomib, cemiplimab, ceritinib, cetuximab, gilteritinib, cobimetinib, copanlisib, crizotinib, dabrafenib, dacomitinib, daratumumab, dasatinib, denosumab, dinutuximab. durvalumab, duvelisib, elotuzumab, encorafenib, entrectinib. erdafitinib, erlotinib, fam-trastuzumab deruxtecan-nxki, gefitinib. gemtuzumab, ibritumomab tiuxetan. ibrutinib, imatinib, inotuzumab, ipilumumab, ivosidenib, lapatinib, larotrectinib, lenvatinib, lorlatinib, margetuximab-cmkb, necitumumab, neratinib, nilotinib, niraparib, nivolumab, obinutuzumab, ofatumumab, olaparib, olaratumab, osimertinib. palbociclib, panitumumab, pazopanib, pembrolizumab. pertuzumab. ponatinib, pralsetinib. ramucirumab. regorafenib, ribociclib, rituximab, rucaparib, sorafenib, sunitinib, talazoparib, tivozanib, tositumomab,trametinib, trastuzumab, tucatinib, vandetanib, vemurafenib, vismodegib, or any combination thereof.

[0160] Disclosed herein is a method for treating lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising precision cancer treatment comprising a therapeutically effective amount of one or more antineoplastons, and a therapeutically effective amount of one or more targeted therapies, wherein the antineoplastons comprise AS2-1 and / or A10 and wherein the targeted therapies comprise abemaciclib. ado- trastuzumab emtansine, afatinib, alectinib, alemtuzumab, alpelisib, atezolizumab, avelumab, axitinib, bevacizumab, binimetinib, blinatumomab, bosutinib, brentuximab, brigatinib, cabozantinib, carfilzomib, cemiplimab, ceritinib, cetuximab, gilteritinib, cobimetinib, copanlisib, crizotinib, dabrafenib, dacomitinib, daratumumab, dasatinib, denosumab, dinutuximab, durvalumab, duvelisib, elotuzumab, encorafenib, entrectinib, erdafitinib, erlotinib, fam-trastuzumab deruxtecan-nxki, gefitinib, gemtuzumab, ibritumomab tiuxetan, ibrutinib, imatinib. inotuzumab, ipilumumab, ivosidenib, lapatinib, larotrectinib, lenvatinib, lorlatinib, margetuximab-cmkb, necitumumab, neratinib, nilotinib, niraparib, nivolumab, obinutuzumab. ofatumumab, olaparib, olaratumab, osimertinib. palbocichb. panitumumab. pazopanib, pembrolizumab, pertuzumab, ponatinib, pralsetinib, ramucirumab, regorafenib, ribociclib, rituximab, rucaparib, sorafenib, sunitinib, talazoparib, tivozanib, tositumomab, trametinib, trastuzumab, tucatinib. vandetanib, vemurafenib, vismodegib, or any combination thereof.

[0161] Disclosed herein is a method for treating lung cancer, the method comprising administering to a subject in need thereof a therapeutically effective amount of one or more antineoplastons or a pharmaceutical formulation, wherein the subject has already received or is actively receiving one or more targeted therapies.

[0162] Disclosed herein is a method for treating lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising precision cancer treatment comprising a therapeutically effective amount of one or more antineoplastons, wherein the subject has already received or is actively receiving one or more targeted therapies.

[0163] Disclosed herein is a method for treating lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising a therapeutically effective amount of AS2-1 and / or A10, wherein the subject has already received or is actively receiving one or more targeted therapies.

[0164] Disclosed herein is a method for treating lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising precision cancertreatment comprising a therapeutically effective amount of AS2-1 and / or A 10. wherein the subject has already received or is actively receiving one or more targeted therapies.

[0165] Disclosed herein is a method for treating lung cancer, the method comprising administering to a subject in need thereof a therapeutically effective amount of AS2-1 and / or A10, wherein the subject has already received or is actively receiving one or more targeted therapies and wherein the one or more targeted therapies comprise abemaciclib, ado- trastuzumab emtansine, afatinib, alectinib, alemtuzumab, alpelisib, atezolizumab. avelumab. axitinib, bevacizumab, binimetinib, blinatumomab, bosutinib, brentuximab, brigatinib, cabozantinib, carfdzomib, cemiplimab, ceritinib, cetuximab, gilteritinib, cobimetinib, copanlisib, crizotinib, dabrafenib, dacomitinib, daratumumab, dasatinib, denosumab, dinutuximab. durvalumab, duvelisib, elotuzumab. encorafenib, entrectinib. erdafitinib, erlotinib, fam-trastuzumab deruxtecan-nxki, gefitinib, gemtuzumab, ibritumomab tiuxetan, ibrutinib, imatinib, inotuzumab, ipilumumab, ivosidenib, lapatinib, larotrectinib, lenvatinib, lorlatinib, margetuximab-cmkb. necitumumab, neratinib, nilotinib, niraparib, nivolumab, obinutuzumab, ofatumumab, olaparib, olaratumab, osimertinib. palbociclib, panitumumab, pazopanib. pembrolizumab. pertuzumab. ponatimb. pralsetinib. ramucirumab. regorafenib. ribociclib, rituximab, rucaparib, sorafenib, sunitinib, talazoparib, tivozanib, tositumomab, trametinib, trastuzumab, tucatinib, vandetanib, vemurafenib, vismodegib, or any combination thereof.

[0166] Disclosed herein is a method for treating lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising precision cancer treatment comprising a therapeutically effective amount of one or more antineoplastons, wherein the antineoplastons comprise AS2-1 and / or A10, wherein the subject has already received or is actively receiving one or more targeted therapies and wherein the targeted therapies comprise abemaciclib, ado-trastuzumab emtansine, afatinib, alectinib, alemtuzumab, alpelisib, atezolizumab, avelumab, axitinib, bevacizumab, binimetinib, blinatumomab, bosutinib, brentuximab, brigatinib, cabozantinib, carfdzomib, cemiplimab, ceritinib, cetuximab, gilteritinib, cobimetinib, copanlisib, crizotinib, dabrafenib. dacomitinib, daratumumab, dasatinib, denosumab, dinutuximab, durvalumab, duvehsib, elotuzumab. encorafenib, entrectinib, erdafitinib, erlotinib, fam-trastuzumab deruxtecan-nxki, gefitinib, gemtuzumab, ibritumomab tiuxetan, ibrutinib, imatinib, inotuzumab, ipilumumab, ivosidenib, lapatinib. larotrectinib, Lenvatinib, lorlatinib, margetuximab-cmkb, necitumumab, neratinib, nilotinib. niraparib, nivolumab, obinutuzumab, ofatumumab, olaparib, olaratumab, osimertinib, palbociclib, panitumumab, pazopanib, pembrolizumab, pertuzumab, ponatinib,pralsetinib, ramucirumab, regorafenib, ribociclib, rituximab, rucaparib, sorafenib, sunitinib, talazoparib, tivozanib, tositumomab, trametinib, trastuzumab, tucatinib, vandetanib, vemurafenib, vismodegib, or any combination thereof.

[0167] Disclosed herein is a method for reducing metastases in a subject having lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising a therapeutically effective amount of one or more antineoplastons or a pharmaceutical formulation thereof, and a therapeutically effective amount of one or more targeted therapies, wherein the subject demonstrates a tumor response and / or molecular response to treatment regimen, and wherein metastases are prevented and / or decreased.

[0168] Disclosed herein is a method for reducing metastases in a subject having lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising precision cancer treatment comprising a therapeutically effective amount of one or more antineoplastons, and a therapeutically effective amount of one or more targeted therapies, wherein the subject demonstrates a tumor response and / or molecular response to treatment regimen, and wherein metastases are prevented and / or decreased.

[0169] Disclosed herein is a method for reducing metastases in a subject having lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising a therapeutically effective amount of AS2-1 and / or A10, and a therapeutically effective amount of one or more targeted therapies, wherein the subject demonstrates a tumor response and / or molecular response to treatment regimen, and wherein metastases are prevented and / or decreased.

[0170] Disclosed herein is a method for reducing metastases in a subject having lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising precision cancer treatment comprising a therapeutically effective amount of AS2- 1 and / or A10, and a therapeutically effective amount of one or more targeted therapies, wherein the subject demonstrates a tumor response and / or molecular response to treatment regimen, and wherein metastases are prevented and / or decreased.

[0171] Disclosed herein is a method for reducing metastases in a subject having lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising a therapeutically effective amount of AS2-1 and / or A10, and a therapeutically effective amount of one or more targeted therapies, wherein the one or more targeted therapies comprise abemaciclib, ado-trastuzumab emtansine, afatinib, alectinib, alemtuzumab, alpelisib, atezolizumab, avelumab, axitinib, bevacizumab. binimetinib. blinatumomab, bosutinib, brentuximab, brigatinib, cabozantinib, carfilzomib, cemiplimab, ceritinib, cetuximab,gilteritinib, cobimetinib, copanlisib, crizotinib, dabrafenib, dacomitinib, daratumumab, dasatinib, denosumab, dinutuximab, durvalumab, duvelisib. elotuzumab, encorafenib, entrectinib, erdafitinib, erlotinib, fam-trastuzumab deruxtecan-nxki, gefitinib, gemtuzumab, ibritumomab tiuxetan, ibrutinib, imatinib, inotuzumab, ipilumumab, ivosidenib, lapatinib, larotrectinib, Lenvatinib, lorlatinib, margetuximab-cmkb, necitumumab, neratinib, nilotinib, niraparib, nivolumab. obinutuzumab, ofatumumab, olaparib, olaratumab, osimertinib, palbociclib, panitumumab, pazopanib, pembrolizumab, pertuzumab, ponatinib, pralsetinib. ramucirumab, regorafenib, ribociclib, rituximab, rucaparib, sorafenib, sunitinib, talazoparib, tivozanib, tositumomab, trametinib, trastuzumab, tucatinib, vandetanib, vemurafenib, vismodegib, or any combination thereof, wherein the subject demonstrates a tumor response and / or molecular response to treatment regimen, and wherein metastases are prevented and / or decreased.

[0172] Disclosed herein is a method for reducing metastases in a subject having lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising precision cancer treatment comprising a therapeutically effective amount of one or more antineoplastons, and a therapeutically effective amount of one or more targeted therapies, wherein the antineoplastons comprise AS2-1 and / or A10 and wherein the targeted therapies comprise abemaciclib, ado-trastuzumab emtansine, afatinib, alectinib, alemtuzumab, alpelisib, atezolizumab, avelumab, axitinib, bevacizumab, binimetinib. blinatumomab, bosutinib, brentuximab. brigatinib, cabozantinib, carfilzomib. cemiplimab, ceritinib. cetuximab, gilteritinib, cobimetinib, copanlisib, crizotinib, dabrafenib, dacomitinib, daratumumab, dasatinib, denosumab, dinutuximab, durvalumab, duvelisib, elotuzumab, encorafenib, entrectinib, erdafitinib, erlotinib, fam-trastuzumab deruxtecan-nxki, gefitinib, gemtuzumab, ibritumomab tiuxetan. ibrutinib, imatinib, inotuzumab, ipilumumab. ivosidenib, lapatinib, larotrectinib, Lenvatinib, lorlatinib, margetuximab-cmkb, necitumumab, neratinib, nilotinib, niraparib, nivolumab, obinutuzumab, ofatumumab, olaparib, olaratumab, osimertinib, palbociclib, panitumumab, pazopanib, pembrolizumab, pertuzumab, ponatinib, pralsetinib, ramucirumab, regorafenib, ribociclib, rituximab, rucaparib, sorafenib, sunitinib, talazoparib, tivozanib, tositumomab, trametinib, trastuzumab, tucatinib. vandetanib. vemurafenib. vismodegib, or any combination thereof, wherein the subject demonstrates a tumor response and / or molecular response to treatment regimen, and wherein metastases are prevented and / or decreased.

[0173] Disclosed herein is a method for reducing metastases in a subject having lung cancer, the method comprising administering to a subject in need thereof a therapeutically effectiveamount of one or more antineoplastons or a pharmaceutical formulation, wherein the subject has already received or is actively receiving one or more targeted therapies, wherein the subject demonstrates a tumor response and / or molecular response, and wherein metastases are prevented and / or decreased.

[0174] Disclosed herein is a method for reducing metastases in a subject having lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising precision cancer treatment comprising a therapeutically effective amount of one or more antineoplastons, wherein the subject has already received or is actively receiving one or more targeted therapies, wherein the subject demonstrates a tumor response and / or molecular response to treatment regimen, and wherein metastases are prevented and / or decreased.

[0175] Disclosed herein is a method for reducing metastases in a subject having lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising a therapeutically effective amount of AS2-1 and / or A10, wherein the subject has already received or is actively receiving one or more targeted therapies, wherein the subject demonstrates a tumor response and / or molecular response to treatment regimen, and wherein metastases are prevented and / or decreased.

[0176] Disclosed herein is a method for reducing metastases in a subject having lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising precision cancer treatment comprising a therapeutically effective amount of AS2- 1 and / or A 10, wherein the subject has already received or is actively receiving one or more targeted therapies, wherein the subject demonstrates a tumor response and / or molecular response to treatment regimen, and wherein metastases are prevented and / or decreased.

[0177] Disclosed herein is a method for treating lung cancer, the method comprising administering to a subject in need thereof a therapeutically effective amount of AS2-1 and / or A 10, wherein the subject has already received or is actively receiving one or more targeted therapies and wherein the one or more targeted therapies comprise abemaciclib, ado- trastuzumab emtansine, afatinib, alectinib, alemtuzumab, alpelisib, atezolizumab, avelumab, axitinib, bevacizumab, binimetinib, blinatumomab, bosutinib, brentuximab, brigatinib, cabozantinib, carfilzomib, cemiplimab. ceritinib, cetuximab, gilteritinib, cobimetinib. copanlisib, crizotinib, dabrafenib, dacomitinib, daratumumab, dasatinib, denosumab, dinutuximab, dun alumab. duvelisib, elotuzumab, encorafenib, entrectinib, erdafitinib, erlotinib, fam-trastuzumab deruxtecan-nxki, gefitinib, gemtuzumab, ibritumomab tiuxetan, ibrutinib. imatinib. inotuzumab. ipilumumab. ivosidenib, lapatinib, larotrectinib, lenvatinib, lorlatinib, margetuximab-cmkb, necitumumab, neratinib, nilotinib, niraparib, nivolumab,obinutuzumab, ofatumumab, olaparib, olaratumab, osimertinib. palbociclib, panitumumab, pazopanib, pembrolizumab. pertuzumab. ponatinib, pralsetinib. ramucirumab. regorafenib, ribociclib, rituximab, rucaparib, sorafenib, sunitinib, talazoparib, tivozanib, tositumomab, trametinib, trastuzumab, tucatinib, vandetanib, vemurafenib, vismodegib, or any combination thereof, wherein the subject demonstrates a tumor response and / or molecular response, and wherein metastases are prevented and / or decreased.

[0178] Disclosed herein is a method for treating lung cancer, the method comprising administering to a subject in need thereof a treatment regimen comprising precision cancer treatment comprising a therapeutically effective amount of one or more antineoplastons, wherein the antineoplastons comprise AS2-1 and / or A10, wherein the subject has already received or is actively receiving one or more targeted therapies and wherein the targeted therapies comprise abemaciclib, ado-trastuzumab emtansine, afatinib, alectinib, alemtuzumab, alpelisib, atezolizumab, avelumab, axitinib, bevacizumab, binimetinib, blinatumomab, bosutinib, brentuximab, brigatinib, cabozantinib, carfilzomib, cemiplimab, ceritinib, cetuximab, gilteritinib, cobimetinib, copanlisib, crizotinib. dabrafenib. dacomitinib, daratumumab, dasatinib, denosumab, dinutuximab, durvalumab, duvehsib, elotuzumab. encorafenib, entrectinib, erdafitinib, erlotinib, fam-trastuzumab deruxtecan-nxki, gefitinib, gemtuzumab, ibritumomab tiuxctan. ibrutinib, imatinib, inotuzumab, ipilumumab, ivosidenib, lapatinib. larotrectinib, Lenvatinib, lorlatinib. margetuximab-cmkb, necitumumab, neratinib, nilotinib. niraparib, nivolumab, obinutuzumab, ofatumumab, olaparib, olaratumab, osimertinib, palbociclib, panitumumab, pazopanib, pembrolizumab, pertuzumab, ponatinib, pralsetinib, ramucirumab, regorafenib, ribociclib, rituximab, rucaparib, sorafenib, sunitinib, talazoparib, tivozanib, tositumomab, trametinib, trastuzumab, tucatinib, vandetanib, vemurafenib. vismodegib. or any combination thereof, wherein the subject demonstrates a tumor response and / or molecular response to treatment regimen, and wherein metastases are prevented and / or decreased.

[0179] In an aspect, a disclosed treatment regimen can comprise one or more antineoplastons or can comprise a composition comprising one or more antineoplastons. In an aspect, disclosed antineoplastons can comprise phenyl acetate. phenylacetylglutaminate sodium, phenylacetylisoglutaminate sodium, or any combination thereof. In an aspect, a disclosed composition comprising one or more antineoplastons can comprise phenyl acetate, phenylacety lglutaminate sodium, phenylacetylisoglutaminate sodium, or any combination thereof.

[0180] In an aspect, a disclosed composition comprising one or more antineoplastons can comprise a pharmaceutically acceptable carrier. In an aspect, the disclosed one or more antineoplastons can comprise phenylacetylglutaminate sodium (PG) and phenylacetylisoglutaminate sodium (iso-PG). In an aspect, a disclosed ratio of phenylacetylglutaminate sodium (PG) and phenylacetylisoglutaminate sodium (iso-PG) can be about 10:1. about 9: 1, about 8: 1, about 7: 1, about 6: 1, about 5: 1, about 4: 1, about 3: 1, about 2: 1, or about 1: 1. In an aspect, a disclosed ratio of phenylacetylglutaminate sodium (PG) and phenylacetylisoglutaminate sodium (iso-PG) can range from about 10:1 to about 1: 10. In an aspect, a disclosed ratio of phenylacetylglutaminate sodium (PG) and phenylacetylisoglutaminate sodium (iso-PG) can be about 4: 1. In an aspect, a dose of the disclosed one or more antineoplastons can comprise about 0.1 g / kg / day to about 20 g / kg / day. In an aspect, a therapeutically effective dose of the disclosed one or more antineoplastons can comprise about 0.1 g / kg / day to about 20 g / kg / day. In an aspect, a disclosed dose of phenylacetylglutaminate sodium (PG) can comprise about 0.4 g / kg / day to about 20 g / kg / day, and a disclosed dose of phenylacetylisoglutaminate sodium (iso-PG) can comprise about 0. 1 g / kg / day to about 5 g / kg / day. In an aspect, a disclosed therapeutically effective amount of phenylacetylglutaminate sodium (PG) can comprise about 0.4 g / kg / day to about 20 g / kg / day. In an aspect, a disclosed therapeutically effective amount of phenylacetylisoglutaminate sodium (iso-PG) can comprise about 0.1 g / kg / day to about 5 g / kg / day.

[0181] In an aspect, the disclosed one or more antineoplastons can comprise phenylacetate (PN) and phenylacetylglutaminate (PG). In an aspect, a disclosed ratio of phenylacetate (PN) and phenylacetylglutaminate (PG) can be about 10: 1, about 9:1, about 8: 1, about 7: 1, about 6: 1, about 5: 1, about 4: 1, about 3: 1, about 2: 1, or about 1: 1. In an aspect, a disclosed ratio of phenylacetate (PN) and phenylacetylglutaminate (PG) can range from about 10: 1 to about 1 : 10. In an aspect, a disclosed ratio of phenylacetate (PN) and phenylacetylglutaminate (PG) can be about 4: 1.

[0182] In an aspect, a dose of the disclosed one or more antineoplastons can comprise about 0.08 g / kg / day to about 0.6 g / kg / day. In an aspect, a therapeutically effective dose of the disclosed one or more antineoplastons can comprise about 0.08 g / kg / day to about 0.6 g / kg / day. In an aspect, a disclosed dose of phenylacetate (PN) can comprise about 0.064 g / kg / day to about 0.48 g / kg / day, and a disclosed dose of phenylacetylglutaminate (PG) can comprise about 0.016 g / kg / day to about 0.12 g / kg / day. In an aspect, a therapeutically effective dose of phenylacetate (PN) can comprise about 0.064 g / kg / day to about 0.48 g / kg / day. and atherapeutically effective phenylacetylglutaminate (PG) can comprise about 0.016 g / kg / day to about 0. 12 g / kg / day.

[0183] In an aspect, the maximum daily dose of AS2-1 does not exceed 0.6 g / kg / day.

[0184] In an aspect, the maximum daily dose of A10 does not exceed 25 g / kg / day.

[0185] In an aspect of a disclosed method of treating cancer, administering a disclosed treatment regimen can comprise intravenous administration. In an aspect, a disclosed treatment regimen can be administered to a subject intravenously using, for example, a dual-channel infusion pump or two single channel pumps and central venous catheter. In an aspect, a disclosed IV administration of a disclosed treatment regimen can occur once every' four hours at the infusion rate of from about 50 mL / hr to about 250 mL / hr (e.g., about 50, 75, 100, 125, 150, 175. 200, 225, 250 mL / hr) depending on the subject's age and condition / tolerance. In an aspect, ANPs can be delivered via an ambulatory infusion pump and subclavian catheter. In an aspect, the dose of AS2-1 can be gradually escalated from 0.1 g / kg / day to a maximum of 0.4 g / kg / day after 4 days and a flow rate from 50 mL / hr to 250 mL / hr by the personnel of BC. In an aspect, the dose of A10 can be increased to the maximum of 12 g / kg / day. In an aspect, a treating clinician can determine the appropriate dose of each ANP administered to a subject.

[0186] In an aspect, a disclosed method of treating cancer can comprise titrating the dose of a disclosed treatment regimen. In an aspect, a disclosed method of treating cancer can comprise titrating the dose of A10, AS2-1, or a combination thereof. In an aspect, a disclosed method of treating cancer can comprise titrating the dose of a disclosed ANP, a disclosed targeted therapy, a disclosed composition, a disclosed pharmaceutical formulation, a disclosed therapeutic agent, a disclosed immune modulator, a disclosed proteasome inhibitor, a disclosed small molecule, a disclosed endonuclease, a disclosed oligonucleotide, a disclosed RNA therapeutic, or any combination thereof to identify an effective dose and / or to identify an effective dose eliciting only mild adverse and / or side effects.

[0187] In an aspect, a disclosed method of treating cancer can comprise titrating the dose of a disclosed treatment regimen in a specific or disclosed subject. In an aspect, a disclosed method of treating cancer can comprise titrating the dose of A10, AS2-1, or a combination thereof in a specific or disclosed subject. In an aspect, a disclosed method of treating cancer can comprise titrating the dose of a disclosed composition, a disclosed pharmaceutical formulation, a disclosed therapeutic agent, a disclosed immune modulator, a disclosed proteasome inhibitor, a disclosed small molecule, a disclosed endonuclease, a disclosed oligonucleotide, a disclosed RNA therapeutic, or any combination thereof to identify an effective dose and / or to identify an effective dose eliciting only mild adverse and / or side effects for a specific or disclosed subject.

[0188] In an aspect, administering comprises administering to the subject the maximum tolerated dose of A10, AS2-1, or both. In an aspect, administering comprises administering to the subject less than the maximum tolerated dose of A10, AS2-1, or both.

[0189]

[0190] In an aspect, a disclosed method can comprise measuring one or more biomarkers. In an aspect, a disclosed biomarker can refer to a biological marker characterizing a phenotype. In an aspect, a disclosed biomarker typically can include a gene or a gene product. Depending on the gene, detecting a biomarker can include detecting altered gene expression, epigenetic modifications, germ-line or somatic mutations, etc. In an aspect of a disclosed gene product, detecting a biomarker can mean detecting the presence, quantity or change in the quantity' of a cell surface marker, a soluble compound such as cytokine, or any combination thereof. In an aspect, detecting a biomarker can include detecting gene expression (mRNA or protein) or a metabolite reflective of a gene's expression or activity7.

[0191] In an aspect, a disclosed method can further comprise administering to the subject one or more biosimilars. In an aspect, biosimilar can refer to a biologic product that is highly similar to the reference product approved by a regulatory agency (e.g., the Federal Drug Administration (FDA) or the European Medicines Agency (EMA)) based on data from (i) analytical studies demonstrating that the biologic product is highly similar to the reference product notwithstanding minor differences in clinically inactive components; (ii) animal studies (including the assessment of toxicity); and / or (iii) a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics) that are sufficient to demonstrate safety7, purity7, and potency in one or more appropriate conditions of use for which the reference product is approved and intended to be used and for which approval is sought (e.g., that there are no clinically meaningful differences between the biologic product and the reference product in terms of the safety, purity, and potency of the product). In an aspect, the biosimilar product can be an interchangeable product as determined by a regulatory agency (e.g., the FDA).

[0192] In an aspect, a disclosed biosimilar can comprise an FDA approved biosimilar (e.g., Bkemv (eculizumab-aeeb), Yesafili (aflibercept-jbvf)- Opuviz (aflibercept-yszy), Hercessi (trastuzumab-strf), Selarsdi (ustekinumab-aekn), Tyenne (tocilizumab-aazg), Jubbonti (denosumab-bbdz), Wyost (denosumab-bbdz), Simlandi (adalimumab-ryvk), Avzivi (bevacizumab-tnjn), Wezlana (ustekinumab-auub), Tofidence (tocilizumab-bavi), Tyruko (natalizumab-sztn), Yuflyma (adalimumab-aaty). Idacio (adalimumab-aacf), Vegzelma (bevacizumab-adcd), Stimufend (pegfilgrastim-fpgk), Cimerli (ranibizumab-eqm), Fylnetra(pegfilgrastim-pbbk), Alymsys (bevacizumab-maly), Releuko (filgrastim-ay ow), Yusimry (adalimumab-aqvh), Rezvoglar (insulin glargine-aglr), Byooviz (ranibizumab-nuna). Semglee (insulin glargine-yfgn), Riabni (ntuximab-arrx). Hulio (adalimumab-fkjp), Nyvepria (pegfilgrastim-apgf), Avsola (infliximab-axxq), Abrilada (adalimumab-afzb), Ziextenzo (pegfilgrastim-bmez), Hadlima (adalimumab-bwwd), Ruxience (rituximab-pvvr), Zirabev (bevacizumab-bvzr), Kanjinti (trastuzumab-anns), Eticovo (etanercept-ykro), Trazimera (trastuzumab-qyyp), Ontruzant (trastuzumab-dtb), Herzuma (trastuzumab-pkrb), Truxima (rituximab-abbs), Udenyca (pegfdgrastim-cbqv), Hyrimoz (adalimumab-adaz), Nivestym (filgrastim-aafi), Fulphila (pegfilgrastim-jmdb), Retacrit (epoetin alfa-epbx), Ixifi (infliximab- qbtx), Ogivri (trastuzumab-dkst), Mvasi (bevacizumab-awwb). Cyltezo (adalimumab-adbm), Renflexis (infliximab-abda). Amj evita (adalimumab-atto), Erelzi (etanercept-szzs). Inflectra (infliximab-dyyb), Zarxio (filgrastim-sndz), or any combination thereof.

[0193] In an aspect, a disclosed ANP can be continuously administered. In an aspect, continuously can refer to an administration with nearly no interruption or gap, preferably without any interruption and gaps. In an aspect, a disclosed targeted therapy can be continuously administered. In an aspect, continuously can refer to an administration with nearly no interruption or gap, preferably without any interruption and gaps. In an aspect, a disclosed anti-cancer therapy can be continuously administered. In an aspect, continuously can refer to an administration with nearly no interruption or gap, preferably without any interruption and gaps.

[0194] In an aspect, IV administration of a disclosed treatment regimen can comprise an outpatient setting. In an aspect, A10 can be administering prior to, concurrent with, or after administering of AS2-1. In an aspect, AS2-1 can be administering prior to, concurrently with, or after administering of A 10. In an aspect, the order of administering one or more antineoplastons can change during a treatment regimen.

[0195] In an aspect, a disclosed method of treating cancer can further comprise obtaining a biological sample from the subject prior to administering a disclosed treatment regimen. In an aspect, a disclosed method of treating cancer can further comprise obtaining a biological sample from the subject after administering a disclosed treatment regimen. In an aspect, a disclosed method can comprise assaying a biological sample for one or more genomic aberrations. In an aspect, a disclosed method can comprise assaying a biological sample for copy number amplification of one or more genes.

[0196] In an aspect, a disclosed method of treating cancer can further comprise subjecting the biological sample to a genetic analysis and / or a cell-free DNA (cfDNA) analysis. Geneticanalyses are known to the skilled person in the art. cfDNA analyses are known to the skilled person in the art. In an aspect, a disclosed genetic analysis and / or a cfDNA analysis can be repeated one or more times. In an aspect, a disclosed obtaining step can be repeated one or more times. In an aspect of a disclosed method of treating cancer, a disclosed cfDNA analysis can comprise next generation sequencing. In an aspect, platforms for NGS can include, but are not limited to, the Roche / 454 Genome Sequencer (GS) FLX system and the Illumina / Solexa Genome Analyzer (GA), Life / APG's Support Oligonucleotide Ligation Detection (SOLiD) system, Polonator's G.007 system, and Helicos BioSciences' Heli Scope Gene Sequencing system, the PromethlON, GrilON, and Mini ON systems from Oxford Nanopore Technologies, and the PacBio RS system from Pacific Biosciences. In an aspect, next generation sequencing (NGS) can comprise using one or more commercially available platforms. Commercially available NGS sequencing platforms can comprise, for example, Guardant360 CDx (Guardant Health, Inc.), FoundationOne CDx (FICDx) (Foundation Medicine, Inc.), or Tempus xT (Tempus).

[0197] With respect to the Guardant360 platform, a genomic aberration in a disclosed cancer- related gene can comprise a single nucleotide variant. For example, in an aspect, a disclosed single nucleotide variant can be identified in the following genes - AKT1, ALK, APC, AR, ARAF, ATM, BRAF, BRCA1, BRCA2, CCND1, CDH1, CDK4, CDK6, CDK12, CDKN2A, CTNNB1, EGFR, ERBB2, ESRI, FGFR1, FGFR2, FGFR3, GATA3, GNA11, GNAQ, HRAS, IDH1, IDH2. KIT. KRAS, MAP2K1, MAP2K2, MET, MLH1, MTOR, MFC, NFL NFE2L2, NRAS, NTRK1, NTRK3, PDGFRA, PIK3CA, PTEN, RAFI, RET, RHEB, ROS1, SMAD4, SMO, STK11, TERT, TSC1, VHL, or any combination thereof. With respect to the Guardant360 platform, a genomic aberration in a disclosed cancer-related gene can comprise an insertion and / or deletion. For example, in an aspect, a disclosed Indel can be identified in the following genes - AKT1, ALK, APC, ATM, BRAF, BRCA1, BRCA2, CDH1, CDK12, CDKN2A, EGFR, ERBB2, ESRI, FGFR2, GATA3, HNF1A, HRAS, KIT, KRAS, MET, MLH1, NF1, PDGFRA, PIK3CA, PTEN, RET, ROS1, STK11, TSC1, VHL, or any combination thereof. With respect to the Guardant360 platform, in an aspect, a genomic aberration in a disclosed cancer-related gene can comprise a copy number amplification (CNA). For example, in an aspect, a disclosed CNA can be identified in the following genes - ERBB2 and / or MEH. With respect to the Guardant360 platform, in an aspect, a disclosed fusion can comprise ALK, NTRK1, RET, ROSE or any combination thereof.

[0198] With respect to the Foundation platform, in an aspect, a genomic aberration in a disclosed cancer-related gene can comprise a substitution, an Indel, or a copy numberamplification. For example, in an aspect, a disclosed substitution, a disclosed Indel, or a disclosed CNA can be identified in the following genes -ABL1, ACVR1B, AKT1, AKT2. AKT3, ALK, AL0X12B, AMER1 (FAM723B), APC, AR. ARAE ARFRP1, ARID1A, ASXLL ATM, ATR, ATRX, AURKA. AURKB, AXIN1. AXL, BAP1, BARD1, BCL2, BCL2LI, BCL2L2, BCL6, BCOR, BCORL1, BRAF, BRCAI, BRCA2, BRD4, BRIP1, BTG1, BTG2, BTK C11ORF30 (EMSY), CALR CARD11, CASP8, CBFB, CBL, CCND1, CCND2, CCND3, CCNE1, CD22, CD274 (PD-L7). CD70, CD79A, CD79B, CDC73, CDH1, CDK12, CDK4, CDK6, CDK8, CDKN1A. CDKN1B, CDKN2A, CDKN2B, CDKN2C, CEBPA, CHEK7, CHEK2. CIC, CREBBP, CRKL, CSFIR, CSF3R, CTCF, CTNNA1, CTNNB1, CUL3, CUL4A, CXCR4, CYP17A1, DAXX, DDRI, DDR2, DIS3, DNMT3A, DOT IL, EED, EGFR, EP 300, EPHA3, EPHB1, EPHB4. ERBB2, ERBB3, ERBB4, ERCC4, ERG, ERRFI1, ESRI, EZH2. FAM46C, FANCA, FANCC, FANCG, FANCL, FAS, FBXW7, FGF10, FGF12. FGF14, FGF19. FGF23, FGF3, FGF4, FGF6, FGFR1, FGFR2, FGFR3, FGFR4, FH, FLCN, FLT1, FLT3, FOXL2, FUBP1, GABRA6, GATA3, GATA4, GATA6, GID4 (C17ORF39), GNA11, GNA13, GNAQ, GNAS, GRM3, GSK3B, H3F3A, HDAC1, HGF, HNF1A, HRAS, HSD3B1, IDS, IDHL IDH2, IGF1R. IKBKE, IKZF1. INPP4B, IRF2, IRF4, IRS2, JAK1, JAK2, JAK3. JUN, KDM5A, KDM5C, KDM6A, KDR, KEAP1, KEL. KIT, KLHL6, KMT2A (MIL), KMT2D (MLL2), KRAS, LTK, LYN, MAP, MAP2K1 (MEK1), MAP2K2 (MEK2), MAP2K4, MAP3K1, MAP3K13, MAPK1, MCL1, MDM2, MDM4, MED12, MEF2B, MEN1, MERTK, MET, MITF, MKNK1, MLH1, MPL. MRE11A, MSH2, MSH3, MSH6. MST1R, MTAP, MTOR, MUTYH, MYC, MYCL (MYCL1). MYCN, MYD88. NBN, NFL NF2, NFE2L2, NFKBIA, NKX2-1, NOTCH1, NOTCH2, NOTCH3, NPM1, NRAS, NT5C2, NTRK1, NTRK2, NTRK3, P2RY8, PALB2, PARK2, PARP1, PARP2, PARP3, PAX5, PBRML PDCD1 (PD-1), PDCD1LG2 (PD-L2), PDGFRA, PDGFRB. PDKL PIK3C2B, PIK3C2G, PIK3CA, PIK3CB, PIK3R1, PIM1, PMS2, POLDI, POLE, PPARG, PP2R1A, PPP2R2A, PRDM1, PRKAR1A, PRKCL PTCHI, PTEN, PTPN11, PTPRO, OKI, RACl. RAD21, RAD51, RAD51B, RAD51C, RAD51D, RAD52, RAD54L, RAFI, RARA, RBI, RBM10, REL, RET, RICTOR RNF43, ROS1, RPTOR, SDHA, SDHB, SDHC, SDHD, SETD2, SF3BL SGK1, SMAD2, SMAD4, SMARCA4, SMARCB1, SMO, SNCAIP, SOCSJ, SOX2, SOX9, SPEN, SPOP, SRC. STAG2, STAT3. STK11, SUFU, SYK, TBX3. TEK, TET2. TGFBR2, TIPARP, TNFAIP3, TNFRSF14. TP53, TSC1. TSC2, TYRO3, U2AF1. VEGFA, VHL, WHSCI (MMSET), WHSC1L1, WT1, XPO1, XRCC2, ZNF217, ZNF703. or any combination thereof. With respect to the Foundation platform, a genomic aberration in a disclosed cancer-related gene can comprise a rearrangement. For example, in an aspect, a disclosed rearrangement can be identified in the following genes - ALK, BCL2,BCR, BRAF, BRCA1, BRCA2, CD74, EGFR, ETV4, ETVS, ETV6, EWSRI, EZR, FGFR1, FGFR2, FGFR3, KIT, KMT2A (MLL), MSH2, MYB. MFC, NOTCH2, NTRKINTRK2 NUTMI, PDGFRA, RAFT. RARA. RET, R0S1, RSP02 SDC4, SLC34A2 TERC (a ncRNA), TERT (promoter only), TMPRSS2, or any combination thereof.

[0199] With respect to the Tempus platform, in an aspect, a genomic aberration in a disclosed cancer-related gene can comprise a rearrangement. For example, in an aspect, a disclosed rearrangement can be identified in the following genes - ABL1. ALK, BCR, BRAF, EGFR, ETV6, EWSRI, FGFR2, FGFR3, MYB, NRG], NTRK1, NTRK2, NTRK3, PAX8, PDGFRA, PML, RARA, RET, ROS1, TFE3, TMPRSS2, or any combination thereof. With respect to the Tempus platform, in an aspect, a genomic aberration in a disclosed cancer-related gene can comprise a single nucleotide variant, an Ind el, or a copy number amplification. For example, in an aspect, a disclosed single nucleotide variant, a disclosed Indel, or a disclosed CNA can be identified in the following genes - ABCB1, ABCC3, ABL1, ABL2, ABRAXAS], ACTA2, ACVR1, (ALK2), ACVR1B, AGO1, AJUBA, AKT1, AKT2, AKT3, ALK, AMER1, APC, APLNR, APOB, AR, ARAE ARHGAP26, ARHGAP35, ARID1A, ARID1B. ARID2, ARID5B, ASNS, ASPSCR1, ASXL1. ATIC, ATM, ATP7B, APR. ATRX, AURKA, AURKB, AXIN], AXIN2, AXL, B2M, BARI, BARD1, BCL10, BCL11B, BCL2, BCL2L1, BCL2L11, BCL6, BCL7A, BCLAF1, BCOR BCORL1, BCR BIRC3, BLM, BMPR1A, BRAF, BRCA1, BRCA2, BRD4, BRIP1, BTG1, BTK, BUB IB. Cllorf65, C3orf70, C8orf34, CALR CARD11, CARMI, CASP8, CASR, CBFB, CBL, CBLB, CBLC. CBR3, CCDC6, CCND1, CCND2, CCND3, CCNE1, CD19, CD22, CD274, (PD-L1), CD40, CD70, CD79A, CD79B, CDC73. CDH1, CDK12. CDK4, CDK6, CDK8, CDKN1A, CDKN1B, CDKN1C, CDKN2A, CDKN2B, CDKN2C, CEBPA, CEP57, CFTR, CHD2, CHD4, CHD7, CHEK1, CHEK2, CIC, CIITA, CKS1B, CREBBP, CRKL, CRLF2, CSF1R, CSF3R, CTC1. CTCF, CTLA4, CTNNA1, CTNNB1, CTRC, CUL1, CUL3, CUL4A, CUL4B, CUXL CXCR4, CYLD, CYP1B1, CYP2D6. CYP3A5, CYSLTR2, DAXX, DDB2, DDR2, DDX3X, DICER], DIRC2, DIS3, DIS3L2, DKC1, DNM2, DNMT3A, DOT1L, DPYD, DYN, C2H1, EBF1, ECT2L, EGF, EGFR, EGLN1, EIF1AX, ELF3, ELOC, (TCEB1), EMSY, ENG. EP 300, EPC AM, EPHA2. EPHA7, EPHB1, EPHB2, EP OR, ERBB2, (HER2), ERBB3, ERBB4, ERCC1, ERCC2. ERCC3, ERCC4, ERCC5, ERCC6, ERG. ERRFI1. ESRI, ETS1. ETS2, ETV1. ETV4, ETV5. ETV6, EWSRI. EZH2, FAM46C, FANCA. FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCL, FANCM, FAS, FAT1, FBXO11, FBXW7, FCGR2A, FCGR3A, FDPS, FGF1, FGF10, FGF14, FGF2, FGF23, FGF3, FGF4, FGF5, FGF6, FGF7, FGF8, FGF9, FGFR1, FGFR2, FGFR3, FGFR4, FH. FHIT, FLCN, FLTL FLT3, FLT4, FNTB, FOXA], FOXL2, FOXO1. F0X03, FOX, P], FOXQ1, FRS2,FUBP1, FUSG6PD, GABRA6, GALNT12, GATA1, GATA2, GATA3, GATA4, GATA6, GEN1, GLI1, GLI2, GNA11, GNA13, GNAQ. GNAS, GPC3, GPS2, GREM1, GRIN2A, GRM3, GSTP1. Hl 9, H3F3A. HAS3, HAVCR2. HDACL HDAC2, HDAC4, HGF, HIF1A. HIST1H1E, HIST1H3B, HIST1H4E, HLA-A, HLA-B, HLA-C, HLA-DMA, HLA-DMB, HLA-DOA. HLA- DOB, HLA-DPA1, HLA-DPB1, HLA-DPB2, HLA-DQA1, HLA-DQA2, HLA-DQB1, HLA- DQB2, HLA-DRA, HLA-DRB1, HLA-DRB5, HLA-DRB6, HLA-E, HLA-E HLA-G, HNF1A, HNF1B, HOXA1L HOXB13, HRAS. HSD11B2, HSD3B1, HSD3B2. HSP90AA1. HSPH1, IDH1. IDH2. IDOL IFIT1, IFIT2, IFIT3, IFNAR1. IFNAR2, IFNGR1, IFNGR2. IFNL3, IKBKE, IKZF1, IL10RA, IL15, IL2RA, IL6R, IL7R ING1, INPP4B, IRF1, IRF2, IRF4, IRS2, ITPKB, JAK1, JAK2, JAK3, JUN, KAT6A, KDM5A, KDM5C, KDM5D, KDM6A. KDR, KEAP1, KEL, KIF1B, KIT. KLF4, KLHL6. KILN. KMT2A, KMT2B, KMT2C. KMT2D, KRAS, L2HGDH, LAG3, LATSL LCK LDLR. LEF1, LMNA, LMO1, LRP1B, LYN, LZTRL MAD2L2, MAF, MAFB, MAGI2, MALT1, MAP2K1, MAP2K2, MAP2K4, MAP3K1, MAP3K7, MAPK1, MAX, MC1R, MCL1, MDM2, MDM4, MED12, MEF2B, MEN1, MET, MGMT, MIB1, MITF, MKI67. MLH1, MLH3, MLLT3, MN1. MPL, MRE11. MS4A1, MSH2, MSH3, MSH6, MTAP, MTHFD2, MTHFR, MTOR. MTRR. MUTYH. MYB, MYC, MYCL, MYCN, MYD88. MYH11, NBN, NCOR1, NCOR2, NF1, NF2, NFE2L2, NFKBIA, NHP2. NKX2-1. NOPIO, NOTCH1, NOTCH2, NOTCH3, NOTCH4, NPM1, NQO1, NRAS, NRG1, NSD1, NSD2, NT5C2, NTH, LI, NTRK1, NTRK2, NTRK3, NUDT15, NUP98, OLIG2, P2RY8. PAK1, PALB2, PALLD, PAX3, PAX5, PAX7, PAX8. PBRML PCBP1, PDCD1, PDCD1LG2. PDGFRA, PDGFRB, PDK1, PHF6, PHGDH, PHLPP1. PHLPP2, PHOX2B, PIAS4, PIK3C2B, PI, K3, CA, PIK3CB, PI, K3, CD, PIK3CG, PI, K3, Rl, PIK3R2, PIM1, PLCG1, PLCG2, PML, PMS1, PMS2, POLDI, POLE, POLH, POLQ, POTI, POU2F2, PPARA, PPARD, PPARG, PPM ID, PPP1R15A, PPP2R1A, PPP2R2A, PPP6C. PRCC. PRDML PREX2, PRKAR1A, PRKDC, PRKN, PRSS1, PTC, H, 1, PTCH2, PTEN, PTPN11, PTPN13, PTPN22, PTPRD, PTPRT, QKI, RAC1, RAD21, RAD50, RAD51, RAD51B, RAD51C, RAD51D, RAD54L, RAFI, RANBP2, RARA, RASA1, RBI, RBM10, RECQL4, RET, RHEB, RHOA, RICTOR, RINT1, RIT1, RNF139, RNF43, ROS1, RPL5, RPS15, RPS6KB1, RPTOR, RRM1, RSF1, RUNX1, RUNX1T1, RXRA, SCG5, SDHA, SDHAF2, SDHB, SDHC, SDHD, SEC23B. SEMA3C, SETBP 1, SETD2, SF3B1, SGK1, SH2B3, SHH, SLC26A3, SLC47A2, SLC9A3R1, SLIT2, SLX4, SM, AD2, SMAD3, SMAD4, SMARCA1, SMARCA4, SMARCB1, SMARCE1, SMC1A, SMC3, SMO, SOCS1, SOD2. SOXIO, SOX2, SOX9, SPEN, SPINK1, SPOP, SPRED1, SRC, SRSF2, STAG2, STAT3, STAT4, STAT5A, STAT5B, STAT6, STK11. SUFU SUZ12, SYK SYNE1, TAF1, TANC1, TAPI. TAP2, TARBP2, TBC1D12, TBL1XRL TBX3, TCF3, TCF7L2, TCL1A, TERT (promoter) . TET2. TFE3, TFEB,TFEC, TGFBR1, TGFBR2, TIGER TMEM127, TMEM173, TMPRSS2, TNF, TNFAIP3, TNFRSF14, TNFRSFI 7. TNFRSF9, TOPI, TOP2A. TP 53, TP63, TPM1, TPMT. TRAF3, TRAF7, TSC1, TSC2. TSHR, TUSC3, TYMS, U2AF1, UBE2T. UGT1A1, UGT1A9, UMPS, VEGFA, VEGFB, VHL, VSIR, WEE1, WNK1, WNK2, WRN, WT1. XPA, XPC, XPO1, XRCC1, XRCC2, XRCC3, YEATS4, ZFHX3, ZMYM3, ZNF217, ZNF471, ZNF620, ZNF750, ZNRF3, ZRSR2, or any combination thereof.

[0200] With respect to the Tempus platform, the following applies: APC (APC-associated conditions), ATM (Ataxia-Telangiectasia, breast cancer susceptibility, Pancreatic cancer susceptibility), AXIN2 (Oligodontia-colorectal cancer syndrome), BAP1 (BAPltumor predisposition syndrome), BARD1 (breast cancer susceptibility), BLM (Bloom syndrome), BMPR1A (Juvenile polyposis). BRCA1 (Hereditary breast and ovarian cancer). BRCA2 (Hereditary’ breast and ovarian cancer, Fanconi anemia), BRIP1 (Ovarian cancer susceptibility, Fanconi anemia), CDH1 (Hereditary7diffuse gastric cancer, breast cancer susceptibility ), CDK4 (Melanoma susceptibility ), CDKN2A (Melanoma-pancreatic cancer syndrome), CEBPA (Acute myeloid leukemia susceptibility), CHEK2 (breast cancer susceptibility, Colon cancer susceptibility). DICER1 (DICER1 tumor predisposition syndrome). EGFR (Lung cancer susceptibility, TKI resistance), EPC AM (Lynch syndrome), ETV6 (Leukemia susceptibility7, thrombocytopenia susceptibility ), FH (Hereditary leiomyomatosis and renal cell cancer), FLCN (Birt-Hogg-Dube syndrome), GATA2 (GATA2 deficiency with susceptibility to myeloid malignancies). KIT (Familial gastrointestinal stromal tumor). MAX (Hereditary paraganglioma-pheochromocytoma syndrome), MEN1 (Multiple endocrine neoplasia type 1 ), MET (Hereditary papillary renal cell carcinoma), MLH1 (Lynch syndrome, Constitutional mismatch repair deficiency), MSH2 (Lynch syndrome, Constitutional mismatch repair deficiency), MSH3 (MSH3-associated polyposis), MSH6 (Lynch syndrome. Constitutional mismatch repair deficiency), MUTYH (MUTYH-associated polyposis), NBN (Nijmegen breakage syndrome, breast cancer susceptibility), NF1 (Neurofibromatosis type 1), NF2 (Neurofibromatosis ty pe 2), NTHL1 (NTHL1 tumor syndrome, NTHL1 -associated polyposis), PALB2 (breast cancer susceptibility, Pancreatic cancer susceptibility, Ovarian cancer susceptibility, Fanconi anemia), PDGFRA (Familial gastrointestinal stromal tumor. GIST-plus syndrome), PHOX2B (Neuroblastoma susceptibility ), PMS2 (Lynch syndrome. Constitutional mismatch repair deficiency), POLDI (Polymerase proofreading-associated polyposis), POLE (Polymerase proofreading-associated polyposis), PRKAR1A (Camey complex), PTCHI (Gorlin syndrome. Basal cell nevus syndrome). PTEN (PTEN hamartoma tumor syndrome), RAD51C (Ovarian cancer susceptibility', breast cancer susceptibility7, Fanconi anemia),RAD51D (Ovarian cancer susceptibility, breast cancer susceptibility), RBI (Retinoblastoma), RET (Multiple endocrine neoplasia type 2. Familial medullary thyroid cancer), RUNX1 (Acute myeloid leukemia susceptibility), SDHA (Hereditary paraganglioma-pheochromocytoma syndrome), SDHAF2 (Hereditary paraganglioma-pheochromocytoma syndrome), SDHB (Hereditary paraganglioma-pheochromocytoma syndrome), SDHC (Hereditary paraganglioma-pheochromocytoma syndrome). SDHD (Hereditary paragangliomapheochromocytoma syndrome), SMAD4 Juvenile polyposis, Hereditary hemorrhagic telangiectasia), SMARCA4 (Rhabdoid tumor predisposition syndrome), SMARCB1 (Rhabdoid tumor predisposition syndrome, Schwannomatosis), STK11 (Peutz-Jeghers syndrome). SUFU (Gorlin syndrome, Basal cell nevus syndrome), TMEM127 (Hereditary paraganglioma-pheochromocytoma syndrome), TP53 (Li-Fraumeni syndrome), TSC1 (Tuberous sclerosis complex), TSC2 (Tuberous sclerosis complex), VHL (Von Hippel-Lindau syndrome), and WT1 (WT1 -related Wilms tumor).

[0201] In an aspect of a disclosed method of treating cancer, next generation sequencing can comprise sequencing one or more cancer related genes. In an aspect of a disclosed method of treating cancer, sequencing one or more cancer related genes can comprise identifying one or more genomic aberrations. In an aspect, one or more genomic aberrations can comprise somatic genomic aberrations. In an aspect, the disclosed one or more somatic genomic aberrations can comprise mutations, insertions, deletions, chromosomal rearrangements, copy number aberrations, or any combination thereof.

[0202] In an aspect of a disclosed method, one or more genomic aberrations in the biological sample can be detected. In an aspect, a disclosed method can further comprise detecting one or more genomic aberrations in the biological sample. In an aspect, a disclosed method can further comprise identifying one or more genomic aberrations in a panel of genes. In an aspect, disclosed genomic aberrations can be identified in a panel of genes. In an aspect, a disclosed panel of genes can comprise at least one gene, at least two genes, 3 or more genes, 5 or more genes, 7 or more genes, or 10 or more genes. In an aspect, a disclosed panel of genes can comprise 2 or more genes, 3 or more genes, 4 or more genes, 5 or more genes. 6 or more genes, 7 or more genes, 8 or more genes. 9 or more genes, or 10 or more genes. In an aspect, a disclosed panel of genes can comprise any combination of disclosed genes or disclosed cancer- related genes. In an aspect, a disclosed panel of genes can comprise any combination of disclosed genes or disclosed gene aberration identified in Table 6 or Table 7.

[0203] In an aspect, a disclosed method can comprise detecting the expression of one or more disclosed genes and / or one or more disclosed gene aberrations. In an aspect, a disclosedmethod can comprise detecting the expression of one or more genes and / or one or more gene aberrations identified in Table 6 or Table 7.

[0204] In an aspect of a disclosed method, the level of expression of one or more genomic aberrations can be tied to the aggressiveness and / or likelihood of survival. In an aspect of a disclosed method, the expression of the one or more genomic aberrations in a biological sample can be associated with the pathophysiological status of the subject suffering from lung cancer. In an aspect of a disclosed method, the absence and / or the presence of one or more genomic aberrations can be tied to the aggressiveness and / or likelihood of survival. In an aspect of a disclosed method, the absence and / or the presence of one or more genomic aberrations in a biological sample can be associated with the pathophysiological status of the subject suffering from lung cancer. In an aspect, a disclosed method can further comprise generating a library and / or database comprising a listing of genes and / or genomic aberrations affected by the administration of ANPs only. In an aspect, a disclosed method can further comprise generating a library and / or database comprising a listing of genes and / or genomic aberrations affected by the administration of ANPs and one or more targeted therapies.

[0205] In an aspect of a disclosed method of treating cancer, a disclosed cfDNA analysis can comprises quantification of one or more cancer related genes. In an aspect, if the expression and / or amount and / or presence of the disclosed one or more genomic aberrations in the pretreatment biological sample is higher than the expression and / or amount and / or presence of the same one or more genomic aberrations in a control sample, then a disclosed method of treating cancer can comprise diagnosing the subject as being in need of precision cancer treatment. In an aspect, a disclosed control sample can be a sample obtained from a subject not having cancer. In an aspect, a disclosed control sample can be a pooled sample obtained from more than one subject not having cancer.

[0206] In an aspect, a disclosed method can comprise generating a control sample and / or a pooled control sample. In an aspect, a disclosed method can comprise generating a reference sample and / or a pooled reference sample. In an aspect, a disclosed method can comprise generating a range of a control samples and / or a pooled control samples. In an aspect, a disclosed method can comprise generating a range of reference samples and / or a pooled reference samples.

[0207] In an aspect, if the expression and / or amount and / or presence of the disclosed one or more genomic aberrations in the post-treatment biological sample is lower than the expression and / or amount and / or presence of the same one or more genomic aberrations in a pre-treatment sample, then a disclosed method of treating cancer can comprise continuing to administer tothe subject a disclosed treatment regimen. In an aspect, if the expression and / or amount and / or presence of the disclosed one or more genomic aberrations in the post-treatment biological sample is lower than the expression and / or amount and / or presence of the same one or more genomic aberrations in a prior post-treatment sample, then a disclosed method of treating cancer of treating cancer can comprise continuing to administer to the subject a disclosed treatment regimen.

[0208] In an aspect, a disclosed method of treating cancer can further comprise measuring the subject's tumor response to the precision cancer treatment. In an aspect, a subject's tumor response can comprise a partial response or a complete response. In an aspect, a disclosed partial response can comprise a decrease in the size of a tumor or a decrease in one or more tumors by 25% or more when compared to the size of the same tumor or the same one or more tumors prior to treatment. In an aspect, a disclosed partial response can comprise a decrease in the size of a tumor or a decrease in one or more tumors by 50% or more when compared to the size of the same tumor or the same one or more tumors prior to treatment. In an aspect, a disclosed partial response can comprise a decrease in the size of a tumor or a decrease in one more tumors by about 100% or more when compared to the size of the same tumor or the same one or more tumors prior to treatment.

[0209] In an aspect of a disclosed method of treating cancer, a complete response can be defined as complete disappearance of all tumors with no recurrence of tumors for at least four weeks. In an aspect, a partial response can be defined as a 50% reduction in total tumor size wi th such reduction lasting at least four weeks. In an aspect, stable disease can be defined as less than 50% reduction in size but no more than 25% increase in size of the tumor mass lasting for at least twelve weeks. In an aspect, the term "complete response" or "CR" can be used to mean the disappearance of all or substantially all target lesions. In an aspect, any pathological lymph nodes can be <10 mm in the short axis. In an aspect, CR can refer to an about 80%, about 85%, about 90%, about 91%, about 92%, about 93%, about 94%, about 95%, about 96%, about 97%, about 98%, about 99% or about 100% decrease in the sum of the diameters of the target lesions (i.e., loss of lesions), taking as reference the baseline sum diameters. In an aspect, CR can indicate that less than about 10%, about 9%. about 8%, about 7%. about 6%, about 5%. about 4%, about 3%, about 2%, about 1% or less of the total lesion diameter can remain after treatment. In an aspect, the term "partial response" or "PR" can refer to a decrease in tumor progression in a subject as indicated by a decrease in the sum of the diameters of the target lesions, taking as reference the baseline sum diameter. In an aspect, PR can refer to at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sumdiameters. In an aspect, the response to a disclosed method of treating can comprise using those criteria referred to RECIST (Response Evaluation Criteria in Solid Tumours).

[0210] In an aspect, a disclosed method of treating cancer can further comprise measuring the subject's molecular response to a disclosed treatment regimen. In an aspect, a disclosed molecular response can comprise a decrease in the number of somatic genomic aberrations in a disclosed biological sample obtained from the subject. In an aspect, disclosed somatic genomic aberrations can comprise mutations, insertions, deletions, chromosomal rearrangements, copy number aberrations, fusions, or any combination thereof.

[0211] In an aspect, a disclosed molecular marker that can determine one or more suitable precision cancer treatments in one or more disclosed methods can be measured from a sample by high-density expression array, DNA microarray, polymerase chain reaction (PCR), reverse transcriptase PCR (RT-PCR), real-time quantitative reverse transcription PCR (qRT-PCR), serial analysis of gene expression (SAGE), spotted cDNA arrays, GeneChip, spotted oligo arrays, bead arrays, RNA Seq, tiling array, northern blotting, hybridization microarray, in situ hybridization, whole-exome sequencing, whole-genome sequencing, liquid biopsy, nextgeneration sequencing, or any combination thereof.

[0212] In an aspect, a disclosed molecular marker can determine one or more suitable precision cancer treatments for use in a disclosed method of treating cancer can determined from the nucleic acid sequence of the at least one of circulating DNA and / or RNA. In an aspect, a disclosed molecular marker can be assessed from circulating tumor DNA and / or RNA (ctDNA and / or ctRNA); circulating cell-free DNA and / or RNA (cfDNA, cfRNA); or any combination thereof. ctDNA / ctRNA refers to tumor-derived fragmented DNA in the bloodstream that is not associated with cells. cfDNA / cfRNA refers to DNA that is freely circulating in the bloodstream, but is not necessarily of tumor origin. In an aspect, cfDNA / ctDNA can include any whole or fragmented genomic DNA, or mitochondrial DNA, and / or cfRNA / ctRNA can include mRNA, tRNA, microRNA, small interfering RNA, long non-coding RNA (1 ncRNA). In an aspect, cfDNA and / or ctDNA can be a fragmented DNA with a length of at least about 50 base pair (bp), about 100 bp, about 200 bp, about 500 bp, or about 1 kbp. In an aspect, cfRNA and / or ctRNA can be a full length or a fragment of mRNA (e.g.. at least 70% of full- length, at least 50% of full length, at least 30% of full length, etc.). In an aspect, a disclosed molecular marker can be directed against any cancer-related gene disclosed herein.

[0213] In an aspect of a disclosed method of treating cancer, a disclosed cancer-related gene can comprise ABL1, ABL2. ACO2.AC1B. ACVR1B, A K T. AKT1, AKT2. AKT3, AI.K. AMER11, ARC, AR, ARI 1)2. ARAF, ARFRP1, ARID1A, ARID1B, ARID2, ASK, ASPM, ASXL1, ATF1,ATF3, ATM, ATR, ATRX, AURKA, AURKB, AXIN1, AXL, BAD, BAGE, BAGE2, BARI, BARD1, BAX, BCL2, BCL2L1. BCL2L2, BCL6, BCMA, BCOR, BCORL1, BDNF, BLM, BMPR1A, BRACA1, BRAF, BRCA1, BRCA2, BRD4, BRIP1, BTG1, BTK, BUB1, C10ORF54, CAGE1, CARD11, CASP5, CBFB, CBL, CCL1, CCL11, CCL13, CCL14, CCL15, CCL16, CCL17, CCL18, CCL19, CCL2, CCL20, CCL21, CCL22, CCL23, CCL24, CCL25, CCL26, CCL27, CCL28, CCL3. CCL4. CCL5, CCL7, CCL8, CCNA2, CCNB1, CCNB2, CCND, CCNDI, CCND2, CCND3, CCNE1, CCNE2, CCR1, CCR10. CCR2. CCR3. CCR4. CCR5. CCR6, CCR7, CCR8, CCR9, CD123, CD19, CD20, CD25, CD274, CD276, CD30, CD33, CD4, CD79A, CD79B, CD8, CD80, CD86, CDC, CDC2, CDC20, CDC25A, CDC25B, CDC25C, CDC42. CDC6, CDC6; CDC7, CDC73, CDCA8, CDH1, CDK12, CDK2, CDK3, CDK4, CDK6. CDK8. CDKN1A, CDKN1B, CDKN2A, CDKN2B. CDKN2C, CEA. CEBPA, CFS1, CHD2, CHD4, CHEK1, CHEK2, CHK-1, CIC, CLDNDI, CNE2, CREBBP, CRKL, CRLF2, CSF1, CSF1R, CSF3, CTAG1, CTAG1B, CTAG2, CTAG4, CTAG5, CTAG6, CTAG9, CTCF, CTLA4, CTNNA1, CTNNB1, CUL3, CXCL1, CXCL10, CXCL11, CXCL12, CXCL13, CXCL14. CXCL16, CXCL17, CXCL2, CXCL3, CXCL5, CXCL6, CXCL9, CXCRI. CXCR2, CXCR3, CXCR5, CXCR6, CYLD, DAXX, DCC, DDR2, DEPTOR, DICER1, DLD, DLST, DNMT3A, DOT1L, DUSP1, DUSP6, E2F1, EBNA1, EBNA2, EGFR, EMSY, ENOX2, EP 300, EPCAM, EPHA3, EPHA5, EPHA7, EPHB1, ERBB2, ERBB3, ERBB4, ERCC1, EREG, ERG, ERK, ERRFI1, ESRI, EWSR1, EZH2, FAM46C, FANCA, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCL, FAS, FAT1, FBXW7, FGF10. FGF14, FGF19, FGF23, FGF3, FGF4, FGF6, FGFR, FGFR1, FGFR2, FGFR3, FGFR4, FH, FLCN, FLU, FLT1, FLT3, FLT4, FOLH1, FOLR1, F()XL2. FOXP1, FRS2, FUBP1, GABRA6, GADD45A, GAGE1, GAGE10, GAGE12D, GAGE12F, GAGE12J, GAGE13, GAGE2A, GAGE2B, GAGE2C, GAGE2D, GAGE2E. GAGE4, GART, GATA1. GATA2, GATA3. GATA4, GATA6. GID4, GLI1, GNA, GNA11, GNA13, GNAQ, GNAS, GPNMB, GPR124, GRIN2A, GRM3, GSK3B, H3F3A, HAVCR2, HDAC, HDAC1, HDAC5, HGF, HHLA2, HIF1, HIF1A, HIST1H1D, HNF1A, HRAS, HSD3B1, HSP90AA1, ICOSLG, IDH1, IDHla, IDH2, IDH3A, IDH3B, IDO, IGF1R, IGF2, IKBKE, IKZF1, IL1, IL15, ILIA, IL1B, IL6, IL7R. IL8, INHBA. INPP4B. IRF2, IRF4, IRS2. JAK1, JAK2. JAK3, JUN, KDM5A, KDM5C, KDM6A. KDMGA, KDR, REAP, KEL, KIT. KLHL6, KLK3, KRAS, LAG1, LAG3, LMO1, LMP1, LRP1B, LYN, LZTR1, MAD2L1, MAGEA1, MAGEA10, MAGEA12, MAGEA2, MAGEA3, MAGEA4, MAGEA5, MAGEA6, MAGEA7, MAGEA8, MAGEA9, MAGEB1, MAGEBIO, MAGEB16, MAGEB18, MAGEB2, MAGEB3, MAGEB4, MAGEB6, MAGECI. MAGEC2, MAGEC3, MAGED1, MAGED2, MAGED4, MAGED4B, MAGEE1, MAGEE2, MAGEF1, MAGEH1, MAGEL2, MAGI2,MAP2K1, MAP2K2. MAP2K4, MAP3KL MAP3K6. MARK. MCLE MCM. MCM2, MCM3, MCM4. MCM5, MCM6. MCM7, MDH1, MDM2. MDM . MED! 2. MEF26, MEF2B, MEN1, MEE MITF, MLH1, MLL, MI.1.2. MI.I.3. MPL, MRE11A, MSH2. MSH6, MTOR. MUC1, MUTYH. MYC, MYCL, MYCN, MYD88, MYH, MYST3. NCR3LG1, Netrin, NFJ, NF2, NFE2L2, NFKB, NFKB! A. NGF, NKX2-1, NOTCH1, NOTCH2, NOTCH3, NPM1, NBAS. NSDJ, NTRK1, NTRK2, NTRK3. NUP93. OGDH, ORC, ORC1, ORC IL, ORC6L, ORCL, ORCLPCNA, PAK3, PALB2, PAPPA, PARK2, PAX, PAX3. PBRM1. PCNA, PDCDE PDCD1LG2, PDGFRA, PDGFRB, PDHA1, PDK1, PGR, PIK3C2B, PIK3CA, PIK3CB, PIK3CG, PIK3R1, PIK3R2, PIK3RI, PKMYT, PKMYT1, PLCG2, PLK1, PMS2, POLDI, POLE, PPM1A, PPP2R1A, PREX2, PRKAR1A, PRKC1, PRKDC, PRSS8, PTCHI, PTEN, PTPN1, PTPN11, PTPRR, PTTG, PTTGE PTTG2, PTTG3, QK1, RAC1, RAD50, RAD51, RAFI, RANBP1, RARA, RAS, RBI, RBL1, RBM10, RET, RLCTOR, RITE RNF43, ROSE RPTOR, RUNXE RUNX1TE SDHA, SDHB, SDHC, SDHD, SEED2, SF3B SKP2, SLAMF7, SLIT2, SMAD2, SMAD3, SMAD4, SMARCA4, SMARCB1, SMC1A, SMC1L1, SMO, SNCAIP, SOCS SOXIO, SOX2, SOX9, SPAGE SPAG11A, SPAG11B, SPAG16, SPAG17. SPAG4, SPAG5, SPAG6, SPAG7, SPAG8, SPAG9, SPEN, SPOP, SPTAE SRC, SRSF2, STAG2, STAT3, SEAT4, STAT5, STAT5B, STKH, SUCLGE SUCLG2, SUFU, SYK, T(BRACHYURY), TAFE TBC1D8, TBX3, TERC, TERT TERT, TERT Promoter, TET2, TFDPE TGFRB2, TNFAIP3, TNFRSF14, TOPE TOP2A, TOP2B. TP53, TRIB3. TSCE TSC2, TSHR, TUBBS, TYMP, TYMS, U2AFE UNC5A, UNC5B, VEGFA, VHL, VTCNE WEEE WISP3, WTE XAGE1D, XAGE2, XAGE3, XAGE5, XCL1, XCL2, XCR1, XPOE ZBTB2, ZNF217, ZNF703, or any combination thereof.

[0214] In an aspect, a disclosed ALK gene can encode a ALK protein having a G1202R mutation. In an aspect, a disclosed EGFR gene can encode an EGFR protein having a P753L mutation. In an aspect, a disclosed gene can comprise an EML4-ALK fusion. In an aspect, a disclosed gene can have a EWSR1-FLI1 fusion. In an aspect, a disclosed FBXW7 gene can encode a FBXW7 protein having a Y 545C mutation. In an aspect, a disclosed KRAS gene can encode a KRAS protein having a G12V mutation, mutation. In an aspect, a disclosed NF1 gene can have one or more splice site SNVs. In an aspect, a disclosed RET gene can have a K6669 mutation. In an aspect, a disclosed SMAD4 gene can encode a SMAD4 protein having a A406R mutation. In an aspect, a disclosed SMAD4 gene can have a N25 Ifs mutation. In an aspect, a disclosed STK11 gene can encode a STK11 protein having a V390V mutation. In an aspect, a disclosed promoter of a disclosed TERT gene can have one or more SNVs. In an aspect, a disclosed TP53 gene can encode a TP53 protein having a Y126D, R248W, or R273H mutation.

[0215] In an aspect, a disclosed AKT1 gene can encode a AKT1 protein having a E17K or R346H mutation. In an aspect, a disclosed AFC gene can encode an APC protein having a G29G, K445K, or V2716L mutation. In an aspect, a disclosed ARAF gene can encode an ARAF protein having a Y495Y mutation. In an aspect, a disclosed ATM gene can encode a ATM protein having a L1617F mutation. In an aspect, a disclosed BRCA1 gene can encode a BRAC1 protein having a H662Q mutation. In an aspect, a disclosed BRCA2 gene can encode a BRCA2 protein having a D237N mutation. In an aspect, a disclosed CCNDJ gene can encode a CCND1 protein having a 296* mutation. In an aspect, a disclosed CCND1 gene can have one or more amplification mutations. In an aspect, a disclosed CCNE1 gene can encode a CCNE1 protein having a P268P or R95Q mutation. In an aspect, a disclosed CDK4 gene can have one or more amplification mutations. In an aspect, a disclosed CDK6 gene can have one or more amplification mutations. In an aspect, a disclosed CDKN2A gene can encode a CDKN2A protein having a D74N mutation. In an aspect, a disclosed CTNNB 1 gene can encode a CTNNB 1 protein having a S45 subcl onal mutation. In an aspect, a disclosed CCNE1 gene can have one or more amplification mutations. In an aspect, a disclosed EGFR gene can encode an EGFR protein having a V524I mutation. In an aspect, a disclosed EGFR gene can have one or more amplification mutations. In an aspect, a disclosed ERBB2 gene have one or more amplification errors. In an aspect, a disclosed ERBB2 gene can encode a ERBB2 protein having a L841L mutation. In an aspect, a disclosed FGFR gene can encode a FGFR protein having a T320T. S726F, P47P, H791H. or S430fs mutation. In an aspect, a disclosed FGFR gene can have one or more amplification mutations. In an aspect, a disclosed FGFR1 gene can encode a FGFR1 protein having a S726F mutation. In an aspect, a disclosed FGFR1 gene can have one or more amplification mutations. In an aspect, a disclosed FGFR2 gene can encode a CTNNB 1 protein having a R330L mutation. In an aspect, a disclosed GATA3 gene can encode a GATA3 protein having a P433fs43, P409fs, PS405fs, D336fs, S430fs, or c. 1213_1214del mutation. In an aspect, a disclosed GNAS gene can encode a GNAS protein having a G206A mutation. In an aspect, a disclosed KDMGA gene can have a loss of function mutation. In an aspect, a disclosed KIT gene can encode a KIT protein having a G384A mutation. In an aspect, a disclosed MAP2K1 gene can encode a MAP2K1 protein having a K57E mutation. In an aspect, a disclosed MAP2K4 gene can have a loss of exon 2. In an aspect, a disclosed MAP3K1 gene can encode a MAP3K1 protein having a S398 mutation. In an aspect, a disclosed MET gene can encode a MET protein having a T895M or M391 mutation. In an aspect, a disclosed MYC gene can encode a MYC protein having a S244S mutation. In an aspect, a disclosed MYC gene can have one or more amplification mutations. In an aspect, a disclosed NF1 gene canhave a splice cite 480-1 l_4801dell 1 mutation. In an aspect, a disclosed NOTCH1 gene can encode a NOTCH 1 protein having a D1681H mutation. In an aspect, a disclosed NTRK1 gene can encode a NTRK1 protein having a A293A mutation. In an aspect, a disclosed PDGFRA gene can encode a PDGFRA protein having a V299G mutation. In an aspect, a disclosed PIK3CA gene can encode a PIK3CA protein having a Q546H, E542K, E545K, E726K, E39K, E453K, R4-P18del, H104R, or H1047L mutation. In an aspect, a disclosed PIK3CA gene can have one or more amplification mutations. In an aspect, a disclosed PTCHI can have a p.M17 start loss-LOF. In an aspect, a disclosed PTEN gene can encode a PTEN protein having a Y27C, R130*, D252Y, or loss of exons 4-7 mutation.In an aspect, a disclosed RAFI gene can encode a RAFI protein having a P63P mutation. In an aspect, a disclosed RBI gene can encode a RBI protein having a Q217* mutation. In an aspect, a disclosed TP53 gene can encode a TP53 protein having a V73fs, R175G, R196, C176F, G187D, R282W, E287*, E285K, R110P, S241del, 5386fs, or any combination thereof. In an aspect, a disclosed TSC1 gene can encode a TSC1 protein having a P1048R mutation.

[0216] In an aspect, a disclosed APC gene can encode an APC protein having a E888fs, R230C, QI 378*, S457*and / or I1304fs mutation. In an aspect, a disclosed AT? gene can encode an AR protein having a S510R mutation. In an aspect, a disclosed ARID 1 A gene can encode an ARID 1 A protein having a Q802fs mutation. In an aspect, a disclosed BRAF gene can encode a BRAF protein having a V600E mutation. In an aspect, a disclosed EGFR gene can encode an EGFR protein having a D321 D mutation. In an aspect, a disclosed FBXJV7 gene can encode an FBXW7 protein having aR658*mutati on. In an aspect, a disclosed FGFR3 gene can encode an FGFR3 protein having a H290Y mutation. In an aspect, a disclosed GNA11 gene can encode an GNA11 protein having a N244S mutation. In an aspect, a disclosed KRAS gene can encode a KRAS protein having a G12S, G12V, G13D, A146T, and / or p.AGHGD mutation. In an aspect, a disclosed PIK3CA gene can encode a PIK3CA protein having a E542K, 115431, Q546K, E545K, p.E545K, G1049R, and / or H1047L mutation. In an aspect, a disclosed PTEN gene can encode a PTEN protein having a R55fs mutation. In an aspect, a disclosed SMAD4 gene can encode a SMAD4 protein having a D537V, L495R, A451P, and / or Q450H mutation. In an aspect, a disclosed TP53 gene can encode a TP53 protein having a C176Y, S241F. R273H, R248Q, R306*, V173L, and / or R282W mutation.

[0217] In an aspect, a disclosed AKT1 gene can encode an AKT1 protein having a R346H mutation. In an aspect, a disclosed APC gene can encode an APC protein having a S197F mutation. In an aspect, a disclosed APC gene can have a p. A1460Rfs*9 frame shift mutation. In an aspect, a disclosed ERBB2 gene can comprise a V797del mutation. In an aspect, adisclosed ERBB2 gene can comprise an Exon 20 deletion. In an aspect, a disclosed EGFR gene can have one or more amplification mutations. In an aspect, a disclosed EGFR gene can encode an EGFR protein having a V742V mutation. In an aspect, a disclosed CCNE1 gene can have one or more mutations. In an aspect, a disclosed PIK3CA gene can have one or more mutations. In an aspect, a disclosed PIK3CA gene can encode a PIK3CA having an E542K mutation. In an aspect, a disclosed MYC gene can have one or more amplification mutation. In an aspect, a disclosed NF1 gene can encode a NF1 protein having a T1295S mutation. In an aspect, a disclosed NTRK1 gene can encode a NTRKl protein having a R766Q mutation. In an aspect, a disclosed PTEN gene can encode a PTEN protein having a G143S mutation. In an aspect, a disclosed PTEN gene can have a p. 133Yfs*l I frame shift mutation. In an aspect, a disclosed RBI gene can have a H673fs mutation. In an aspect, a disclosed SMAD gene can encode a SMAD protein having a R189H mutation. In an aspect, a disclosed SMAD4 gene can encode a SMAD4 protein having a p.R361H mutation. In an aspect, a disclosed TP53 gene can have a H178_S183del mutation. In an aspect, a disclosed TP53 gene can have a c.376- 4_384del mutation. In an aspect, a disclosed TP53 gene can comprise one or more copy number mutations.

[0218] In an aspect, a disclosed CDKN1A B gene can have one or more mutations. In an aspect, a disclosed SDKN2A gene can have one or more mutations. In an aspect, a disclosed PTEN gene can encode a PTEN protein having a Y27C mutation. In an aspect, a disclosed AKT2 gene can have one or more multiplication errors. In an aspect, a disclosed TP53 gene can have a D281 s mutation.

[0219] In an aspect, a disclosed ALK gene can encode a ALK protein having a N1544K mutation. In an aspect, a disclosed AKT2 gene can have one or more multiplication errors. In an aspect, a disclosed AR gene can encode an AR protein having a M887V mutation. In an aspect, a disclosed ARD gene can encode an ARD protein having a 60 ID mutation. In an aspect, a disclosed ARID1A gene can encode an ARID1 A protein having a G246V or R1889W mutation. In an aspect, a disclosed BRAF gene can have an amplification mutation. In an aspect, a disclosed BRCA2 gene can encode a BRCA2 protein having a El 382* mutation. In an aspect, a disclosed CCND1 gene can encode a CCND1 protein having a R291W mutation. In an aspect, a disclosed MYC gene can have an amplification mutation. In an aspect, a disclosed NF1 gene can encode a protein having a K583R mutation. In an aspect, a disclosed NOTCH1 gene can encode a NOTCH1 protein having a S223N mutation. In an aspect, a disclosed NTRK1 gene can have one or more mutations. In an aspect, a disclosed PIK3CA gene can have an amplification mutation. In an aspect, a disclosed PIK3CA can encode aprotein having a Q597H mutation. In an aspect, a disclosed PTEN gene can encode a PTEN protein having a Y27C mutation. In an aspect, a disclosed PTEN gene can have a H196_1203del mutation. In an aspect, a disclosed RAFI gene can have an amplification mutation. In an aspect, a disclosed SMAD4 gene can encode a SMAD4 protein having a P511 L mutation. In an aspect, a disclosed TP53 gene can have one or more mutations. In an aspect, a disclosed TP 53 gene can encode a protein having a R248W, R176H, V274G. I119F, or T195T mutation. In an aspect, a disclosed TP53 gene can have a N235-Y236del mutation. In an aspect, a disclosed TP53 gene can have a R209fs mutation.

[0220] In an aspect, a disclosed ARID1A gene can have a Q1334-R1335InsQ mutation. In an aspect, a disclosed KRAS gene can encode a KRAS protein having a G12D mutation. In an aspect, a disclosed KIT gene can encode a KIT protein having a H630D mutation. In an aspect, a disclosed NF1 gene can encode a NF1 protein having a H415Y mutation, mutation. In an aspect, a disclosed SMAD4 gene can encode a SMAD4 protein having a R135. In an aspect, a disclosed SMAD4 gene can encode a SMAD4 protein having a R497H. In an aspect, a disclosed TP53 gene can encode a TP53 protein having a C1355 mutation.

[0221] In an aspect, a disclosed ARID 1 A gene can have one or more mutations. In an aspect, a disclosed FBXW7 gene can encode a FBXW7 protein having a C466Y mutation. In an aspect, a disclosed FLT3 gene can comprise a c.2503G>C (p.Asp835His) mutation or a c.2930G>A (p.R997K) mutation. In an aspect, a disclosed POL gene can comprise a c.5398G>A (p.V180M) mutation. In an aspect, a disclosed POTI gene can comprise a c.l 373G>A (p.G458D) mutation. In an aspect, a disclosed GNAQ gene can have one or more mutations. In an aspect, a disclosed GAT A3 gene can have one or more multiplications. In an aspect, a disclosed TP53 gene can encode a TP53 protein having a R248Q or C245S mutation.

[0222] In an aspect, a disclosed genomic aberration can comprise one or more genes and / or gene aberrations listed in Table 6 or Table 7.

[0223] In an aspect, a disclosed method can further comprise surgically resecting one or more tumors from the subject. In an aspect, a disclosed method can further comprise repeating one or more disclosed steps of a disclosed method.

[0224] For example, in an aspect, repeating one or more disclosed steps of a disclosed method can comprise repeating the administering to the subject the treatment regimen, the ANPs, the targeted therapy, and / or precision cancer treatment, repeating the measuring of the subject's tumor response, repeating the obtaining of a biological sample from the subject, repeating the subjecting the biological sample to cfDNA analysis, repeating the administering of one or more additional therapeutic agents, or any combination thereof.

[0225] In an aspect, a disclosed molecular marker can be detected, quantified, and / or analyzed over time (at different time points) to determine the effectiveness of a disclosed treatment regimen (e.g., ANP therapy) to the subject and / or to determine the response of a subject or subject's tumor to the precision cancer treatment (e.g., developing resistance, susceptibility, etc.). In an aspect, a disclosed method can comprise obtaining multiple measurements over time from the same subject and same sample may be quantified at a single time point or over time. In an aspect, a disclosed treatment regimen treatment (e.g., a disclosed treatment regimen comprising one or more antineoplastons) can be designed and / or determined based on the cancer status and / or the changes / types of one or more molecular markers. In an aspect, the likelihood of success of a disclosed treatment regimen can be determined based on the cancer status and the type / quantity of one or more molecular markers.

[0226] In an aspect, a disclosed molecular marker can be derived from a gene expressed in one or more cells of a tumor or in an immune cell and can indicate immune suppressive tumor microenvironment, the development of cancer sternness, the onset of metastasis, cancer status, or any combination thereof. In an aspect, a disclosed molecular marker can be the protein or peptide encoded by the gene from which the molecular marker is derived and can be targeted by an antagonist or any other type of binding molecule to inhibit the function of the peptide.

[0227] Thus, in an aspect, increased expression (e.g., above a predetermined threshold) of a disclosed molecular marker derived from a disclosed gene related to immune suppressive tumor microenvironment can implicate the presence of immune suppressive tumor microenvironment, and can also implicate that an antagonist to the peptide encoded by the gene related to immune suppressive tumor microenvironment can have a high likelihood of success to inhibit the progress of the cancer by inhibiting immune suppressive tumor microenvironment and further promoting immune cell activity against tumor cells in such microenvironment. In an aspect, once the molecular marker has been identified, any suitable antagonist to a target gene or protein product can be used. For example, in an aspect, a specific kinase can be targeted by a kinase inhibitor, or a specific signaling receptor can be targeted by synthetic ligand, or a specific checkpoint receptor targeted by synthetic antagonist or antibody, etc. In an aspect, a disclosed antagonists to a target molecule herein can be administered before, after, or in combination with AS therapy.

[0228] In an aspect, a subject can be a human patient. In an aspect a subject can be any age (e.g., geriatric, adult, young adult, teenager, tween, adolescent, child, toddler, baby, or infant), can be male or female, can be any nationality, can be of any ethnicity, and / or can be of anyrace. In an aspect, a subject can have a terminal cancer. In an aspect, a subject can be treatment naive. Or, in an aspect, a subject can have had or received prior treatment.

[0229] In an aspect, a disclosed subject can have lung cancer. In an aspect, the term "lung tissue" can refer to tissue of the lungs themselves as well as the tissue adjacent to and / or within the strata underlying the lungs and supporting structures such as the pleura, intercostal muscles, ribs, and other elements of the respiratory system. The respiratory system itself can comprise the nasal cavity, sinuses, pharynx, larynx, trachea, bronchi, lungs, lung lobes, aveoli, aveolar ducts, aveolar sacs, aveolar capillaries, bronchioles, respiratory bronchioles, visceral pleura, parietal pleura, pleural cavity7, diaphragm, epiglottis, adenoids, tonsils, mouth and tongue, and the like.

[0230] In an aspect, lung cancer can comprise a malignant neoplasm of the lung characterized by the abnormal proliferation of cells, the growth of which cells exceeds and is uncoordinated with that of the normal tissues around it.

[0231] In an aspect, lung cancer staging definitions can comprise (i) Stage TO (there is no evidence of primary tumor); (ii) Stage Tis (there is carcinoma in situ); (iii) Stage Ti (denotes tumors of 3 cm or less); (iv) Stage Tla (denotes tumors having 2 cm or less); (v) Stage Tib (denotes a tumor having a dimension of more than 2 cm but less than 3 cm); (vi) Stage T2 (denotes tumors of having dimensions of more than 3 cm but 7 cm or less); (vii) Stage T2a (denotes tumors having dimensions of more than 3 cm but 5 cm or less); (viii) Stage T2b (denotes tumors having more than 5 cm in dimension but being 7 cm or less); (ix) Stage T3 (denotes tumors that are more than 7 cm or those tumors that invades the chest wall, phrenic nerve, diaphragm, parietal pleura, parietal pericardium or mediastinal pleura; or a tumor in the main bronchus that is less than 2 cm); and (x) Stage T4 (denotes tumors that invades any of: heart, esophagus, mediastinum, trachea, recurrent laryngeal nerve, carina, vertebral body, or a separate tumor nodule in a different ipsilateral lobe).

[0232] In an aspect, "lung cancer-positive" can refer to classification of a subject as having lung cancer. In an aspect, "lung cancer-negative" can refer to classification of a subject as not having lung cancer. In an aspect, "pulmonary nodules" can refer to lung lesions that can be visualized by radiographic techniques. In an aspect, a pulmonary nodule can be any nodule less than or equal to three centimeters in diameter. In an aspect, "masses" or "pulmonary masses" can refer to lung nodules that are greater than three centimeters maximal diameter.In an aspect, a disclosed subject can have a "cell proliferative disorder of the lung". In an aspect, a disclosed cell proliferative disorder can involve cells of the lung. In an aspect, cell proliferative disorders of the lung can comprise all forms of cell proliferative disordersaffecting lung cells. In an aspect, cell proliferative disorders of the lung can comprise lung cancer, a precancer or precancerous condition of the lung, benign growths or lesions of the lung, and malignant growths or lesions of the lung, and metastatic lesions in tissue and organs in the body other than the lung.

[0233] In an aspect a disclosed cell proliferative disorder of the lung can comprise lung cancer. In an aspect, a disclosed composition or a disclosed pharmaceutical formulation can be used to treat lung cancer. Lung cancer can comprise all forms of cancer of the lung.

[0234] In an aspect, a lung cancer treatable by the disclosed compositions and / or disclosed formulations can comprise (i) a localized tumor of the lung, (ii) a tumor of the lung that is associated with a negative sentinel lymph node (SLN) biopsy, (iii) a tumor of the lung that is associated with a positive sentinel lymph node (SLN) biopsy, (iv) a tumor of the lung that is associated with one or more positive axillary lymph nodes, (v) a tumor of the lung that has been typed as having nodal negative status (e.g., node-negative) or nodal positive status (e.g., node-positive), (vi) a tumor of the lung that has metastasized to other locations in the body, or (vii) any combination thereof. In an aspect, a lung cancer treatable by the disclosed compositions and / or the disclosed formulations can be classified according to a characteristic selected from the group consisting of metastatic, localized, regional, local-regional, locally advanced, distant, multicentric, bilateral, ipsilateral, contralateral, newly diagnosed, recurrent, and inoperable.

[0235] In an aspect of a disclosed method, administering one or more disclosed ANPs, one or more disclosed pharmaceutical compositions, one or more disclosed pharmaceutical formulations, one or more disclosed targeted therapies, one or more disclosed anti-cancer agents, or any combination thereof can comprise a single dose or multiple doses (such as 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 doses). In an aspect of a disclosed method, administering one or more disclosed ANPs, one more disclosed pharmaceutical compositions, one or more disclosed pharmaceutical formulations, one or more disclosed targeted therapies, one or more disclosed anti-cancer agents, or any combination thereof can comprise a single dose or multiple doses (such as 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 doses). In an aspect of a disclosed method, administering a disclosed composition comprising one or more one or more disclosed ANPs, one more disclosed pharmaceutical compositions, one or more disclosed pharmaceutical formulations, one or more disclosed targeted therapies, one or more disclosed anti-cancer agents, or any combination thereof can comprise a single dose or multiple doses (such as 2, 3, 4, 5, 6, 7. 8, 9, 10, or more than 10 doses).

[0236] In an aspect, a disclosed method can further comprise administering to the subject one or more additional anti-cancer therapies. In an aspect, a disclosed anti-cancer therapy can comprise endocrine therapy, radiotherapy, hormone therapy, gene therapy, thermal therapy, ultrasound therapy, or any combination thereof.

[0237] In an aspect, a disclosed anti-cancer therapy can comprise one or more chemotherapeutic agents. In an aspect, a disclosed chemotherapeutic agent can comprise an anthracycline, a vinca alkaloid, an alkylating agent, an immune cell antibody, an antimetabolite, a TNFR glucocorticoid induced TNFR related protein (GITR) agonist, a proteasome inhibitor, an immunomodulator, or any combination thereof. In an aspect, a disclosed chemotherapeutic agent can comprise 5-fluorouracil (Adrucil, Efudex), 6- mercaptopurine (Purinethol), 6-thioguanine, aclarubicin or aclacinomycin A, alemtuzamab (Lemtrada), anastrozole (Arimidex), bicalutamide (Casodex), bleomycin sulfate (Blenoxane), bortezomib (Velcade), busulfan (Myleran), busulfan injection (Busulfex), capecitabine (Xeloda), carboplatin (Paraplatin), carmustine (BiCNU), chlorambucil (Leukeran), cisplatin (Platinol), cladribine (Leustatin), Cosmegan, cyclophosphamide (Cytoxan or Neosar), cyclophosphamide, cytarabine liposome injection (DepoCyt). cytarabine, cytosine arabinoside (Cytosar-U), dacarbazine (DTIC-Dome), dactinomycin (Cosmegen), daunorubicin citrate liposome injection (DaunoXome), daunorubicin hydrochloride (Cerubidine), dexamethasone, docetaxel (Taxotere), doxorubicin hydrochloride (Adriamycin. Rubex), etoposide (Vepesid), fludarabine phosphate (Fludara), flutamide (Eulexin), folic acid antagonists, gemcitabine (difluorodeoxycitidine), gemtuzumab, gliotoxin, hydroxyurea (Hydrea), Idarubicin (Idamycin), ifosfamide (IFEX), ifosfamide, irinotecan (Camptosar), L-asparaginase (ELSPAR), lenalidomide), leucovorin calcium, melphalan (Alkeran), melphalan, methotrexate (Folex), mitoxantrone (Novantrone). mylotarg, N4-pentoxy carbonyl-5 deoxy-5-fluorocytidine, nab-paclitaxel (Abraxane), paclitaxel (Taxol), pentostatin, phoenix (Yttrium90 / MX-DTPA), polifeprosan 20 with carmustine implant (Gliadel), purine analogs and adenosine deaminase inhibitors (fludarabine), pyrimidine analogs, rituximab, tamoxifen citrate (Nolvadex), temozolomide), teniposide (Vumon), tezacitibine, thalidomide or a thalidomide derivative, thiotepa, tirapazamine (Tirazone). topotecan hydrochloride for injection (Hy camptin), tositumomab), vinblastine (Velban), vinblastine, vincristine (Oncovin), vindesine, vinorelbine (Navelbine), or any combination thereof.

[0238] In an aspect, a disclosed targeted therapy can comprise one or more monoclonal antibodies. In an aspect, a disclosed monoclonal antibody can comprise an angiogenesis inhibitor (e.g., bevacizumab), a HER-2 targeted agent (e.g., trastuzumab, pertuzumab, etc.), ananti-CD20 monoclonal antibody (e.g., rituximab, obinutuzumab, etc.), or any combination thereof. In an aspect, a disclosed targeted therapy can comprise one or more small molecule inhibitors. In an aspect, a disclosed small molecule inhibitor can comprise a tyrosine kinase inhibitor (e.g., erlotinib, sunitinib, imatinib, dasatinib, etc.), a mTOR inhibitor (e.g., everolimus), a PARP inhibitor (e.g., olaparib), a CDK inhibitor (e.g., palbociclib, ribociclib, abermaciclib, etc.), a CD4 and / or CD6 inhibitor, or any combination thereof.

[0239] In an aspect, a disclosed targeted therapy can comprise abagovomab, abciximab. abituzumab, abrilumab, actoxumab, adalimumab, adecatumumab, aducanumab, afelimomab, afutuzumab, alacizumab pegol, alemtuzumab, alirocumab, altumomab pentetate, amatuximab, anatumomab mafenatox, anetumab ravtansine, anifrolumab. anrukinzumab, apolizumab, arcitumomab, ascrinvacumab, aselizumab, atezolizumab. atinumab, atlizumab (tocilizumab), atorolimumab, bapineuzumab, basiliximab, bavituximab, bectumomab, begelomab, belimumab, benralizumab, bertilimumab, besilesomab, bevacizumab, bezlotoxumab, biciromab, bimagrumab, bimekizumab, bivatuzumab mertansine, blinatumomab, blosozumab, bococizumab, brentuxim abvedotin. briakinumab, brodalumab, brolucizumab, brontictuzumab, canakinumab, cantuzumab mertansine, cantuzumab ravtansine. caplacizumab, capromab pend etide, carlumab, catumaxomab, cbr96-doxorubicin immunoconjugate, cedelizumab, certolizumab pegol, cetuximab, citatuzumab bogatox, cixutumumab, clazakizumab, clenoliximab, clivatuzumab tetraxetan, codrituzumab, coltuximab ravtansine, conatumumab, concizumab, crenezumab, dacetuzumab. daclizumab, dalotuzumab, dapirolizumab pegol, daratumumab, dectrekumab, demcizumab, denintuzumab mafodotin, denosumab, derlotuximab biotin, detumomab, dinutuximab, diridavumab, dorlimomab aritox, drozitumab, duligotumab, dupilumab, durvalumab, dusigitumab, ecromeximab, eculizumab, edobacomab, edrecolomab, efalizumab, efungumab, eldelumab, elgemtumab, elotuzumab, elsilimomab, emactuzumab, emibetuzumab, enavatuzumab, enfortumab vedotin, enlimomab pegol, enoblituzumab, enokizumab, enoticumab, ensituximab, epitumomab cituxetan, epratuzumab, erlizumab, ertumaxomab, etanercept, etaracizumab, etrolizumab, evinacumab, evolocumab, exbivirumab, fanolesomab, faralimomab, farletuzumab, fasinumab, felvizumab, fezakinumab, ficlatuzumab, figitumumab. firivumab. flanvotumab, fletikumab, fontolizumab, foralumab, foravirumab, fresolimumab, fulranumab, futuximab, galiximab, ganitumab, gantenerumab, gavilimomab, gemtuzumab ozogamicin, gevokizumab, girentuximab, glembatumumab vedotin, golimumab, gomiliximab, guselkumab, ibalizumab, ibritumomab tiuxetan, icrucumab, idarucizumab, igovomab. imalumab, imciromab, imgatuzumab, inclacumab, indatuximab ravtansine, indusatumab vedotin,infliximab, inolimomab. inotuzumab ozogamicin, intetumumab, ipilimumab, iratumumab, isatuximab, itolizumab, ixekizumab, keliximab. labetuzumab, lambrolizumab, lampalizumab, lebrikizumab, lemalesomab, lenzilumab, lerdelimumab, lexatumumab, libivirumab, lifastuzumab vedotin, ligelizumab, lilotomab satetraxetan, lintuzumab, lirilumab, lodelcizumab, lokivetmab, lorvotuzumab mertansine, lucatumumab, lulizumab pegol, lumiliximab, lumretuzumab, mapatumumab, margetuximab, maslimomab, matuzumab, mavrilimumab, mepolizumab, metelimumab, milatuzumab. minretumomab. mirvetuximab soravtansine, mitumomab, mogarnulizumab, morolimumab, motavizumab, moxetumomab pasudotox, muromonab-cd3, nacolomab tafenatox, namilumab, naptumomab estafenatox, namatumab, natalizumab, nebacumab, necitumumab, nemolizumab, nerelimomab, nesvacumab. nimotuzumab. nivolumab, nofetumomab merpentan, obiltoxaximab, obinutuzumab, ocaratuzumab, ocrelizumab, odulimomab, ofatumumab, olaratumab, olokizumab, omalizumab, onartuzumab, ontuxizumab, opicinumab, oportuzumab monatox, oregovomab, orticumab, otelixizumab, otlertuzumab, oxelumab, ozanezumab, ozoralizumab, pagibaximab, palivizumab, panitumumab. pankomab. panobacumab, parsatuzumab, pascolizumab, pasotuxizumab, pateclizumab, patntumab, pembrolizumab, pemtumomab. perakizumab, pertuzumab, pexelizumab, pidilizumab, pinatuzumab vedotin, pintumomab, placulumab, polatuzumab vedotin, ponezumab, pralsetinib, priliximab, pritoxaximab, pritumumab, quilizumab, racotumomab, radretumab, rafivirumab, ralpancizumab, ramucirumab, ranibizumab, raxibacumab, refanezumab. regavirumab, reslizumab, rilotumumab, rinucumab, rituximab, robatumumab, roledumab, romosozumab, rontalizumab, rovelizumab, ruplizumab, sacituzumab govitecan, samalizumab, sarilumab, satumomab pendetide, secukinumab, seribantumab, setoxaximab, sevirumab, sibrotuzumab, sifalimumab, siltuximab. simtuzumab, siplizumab, sirukumab, sofituzumab vedotin, solanezumab, solitomab, sonepcizumab, sontuzumab, stamulumab, sulesomab, suvizumab, tabalumab, tacatuzumab tetraxetan, tadocizumab, talizumab, tanezumab, taplitumomab paptox, tarextumab, tefibazumab, telimomab aritox, tenatumomab, teneliximab, teplizumab, teprotumumab. tesidolumab, tetulomab, ticilimumab, tigatuzumab, tildrakizumab, tocilizumab, torahzumab, tosatoxumab, tositumomab. tovetumab, tralokinumab. trastuzumab, tregalizumab, tremelimumab, trevogrumab, tucotuzumab celmoleukin, tuvirumab, ublituximab, ulocuplumab, urelumab, urtoxazumab, ustekinumab, vandortuzumab vedotin, vantictumab, vanucizumab, vapaliximab, varlilumab, vatelizumab, vedolizumab. veltuzumab, vepalimomab, vesencumab, visilizumab, volociximab, vorsetuzumab mafodotin. votumumab,zalutumumab, zanolimumab, zatuximab, ziralimumab, zolimomab aritox, or any combination thereof.

[0240] In an aspect, a disclosed targeted therapy can comprise abemaciclib, ado-trastuzumab emtansine, afatinib, alectinib, alemtuzumab, alpelisib, atezolizumab, avelumab, axitinib, bevacizumab, binimetinib, blinatumomab, bosutinib, brentuximab, brigatinib, cabozantinib, carfilzomib, cemiplimab, ceritinib, cetuximab, gilteritinib, cobimetinib, copanlisib, crizotinib, dabrafenib. dacomitinib, daratumumab, dasatinib. denosumab. dinutuximab, durvalumab. duvelisib, elotuzumab, encorafenib, entrectinib, erdafitinib, erlotinib, fam-trastuzumab deruxtecan-nxki, gefitinib, gemtuzumab, ibritumomab tiuxetan, ibrutinib, imatinib, inotuzumab, ipilumumab, ivosidenib, lapatinib, larotrectinib, lenvatinib, lorlatinib, margetuximab-cmkb, necitumumab. neratinib, nilotinib, niraparib, nivolumab, obinutuzumab, ofatumumab, olaparib, olaratumab, osimertinib, palbociclib, panitumumab, pazopanib, pembrolizumab, pertuzumab, ponatinib, pralsetinib, ramucirumab, regorafenib, ribociclib, rituximab, rucaparib, sorafenib, sunitinib, talazoparib, tivozanib, tositumomab, trametinib, trastuzumab, tucatinib. vandetanib, vemurafenib, vismodegib, or any combination thereof.

[0241] In an aspect, a disclosed targeted therapy for oral administration can comprise abemaciclib, afatinib, alectinib, alpelisib, axitinib, binimetinib, bosutinib, brigatinib, cabozantinib, cobimetinib, crizotinib, dabrafenib, dacomitinib, dasatinib, duvelisib, encorafenib, entrectinib, erdafitinib. erlotinib, gefitinib, gilteritinib, ibrutinib, imatinib mesylate, ivosidenib, lapatinib, larotrectinib, lorlatinib, lenvatinb, neratinib, nilotinib, niraparib, olaparib, osimertinib palbociclib, pazopanib, ponatinib, pralsetinib, regorafenib, ribociclib, rucaparib, sorafenib, sunitinib malate, talazoparib, tivozanib, trametinib, vandetanib, vemurafenib, vismodegib, or any combination thereof.

[0242] In an aspect, a disclosed targeted therapy for intravenous administration can comprise ado-trastuzumab emtansine, alemtuzumab, atezolizumab, avelumab, bevacizumab, blinatumomab, brentuximab vedotin, carfilzomib, cetuximab, cemiplimab-rwlc, certinib, copanlisib, daratumumab, dinutuximab, durvalumab, elotuzumab, fam-trastuzumab deruxtecan-nxki, gemtuzumab ozogamicin. ibritumomab tiuxetan, inotuzumab ozogamicin, ipilimumab, margetuximab-cmkb, necitumumab, nivolumab, obinutuzumab. olaratumab. panitumumab, pembrolizumab, pertuzumab, ramucirumab, rituximab, tositumomab and iodine 1131 tositumomab, trastuzumab, ublituximab-xiiy, or any combination thereof.

[0243] In an aspect, a disclosed targeted therapy for subcutaneous administration can comprise denosumab, ofatumumab, or any combination thereof.

[0244] In an aspect, a disclosed method of treating cancer can comprise administering to the subject a therapeutically effective amount of a targeted immunotherapy agent (e.g., fam- trastuzumab-deruxtecan-nxki; trastuzumab; Herceptin Hylecta (injectable Herceptin); Herceptin biosimilars (e.g., Herzuma, Kanjinti, Ogivri, Ontruzant, and Trazimera); ado- trastuzumab emtansine; margetuximab-cmkb; pertuzumab, trastuzumab, and hyaluronidase- zzxf; pertuzumab; sacituzumab govitecan-hziy; or any combination thereof).

[0245] ABEMACICLIB. In an aspect, a disclosed targeted therapy can comprise abemaciclib. As described herein, abemaciclib can be known to the art. In an aspect of a disclosed method, administering abemaciclib can comprise oral administration. In an aspect, oral administration can comprise a tablet taken with or taken without food. In an aspect, oral administration does not comprise crushing, cutting, or chewing the tablet. In an aspect, administration can comprise swallowing the tablet whole. In an aspect, abemaciclib can be used alone (e.g., as a monotherapy). In an aspect, abemaciclib can be used in combination with fulvestrant, tamoxifen, or an aromatase inhibitor. In an aspect, abemaciclib can be used in combination with trastuzumab and chemotherapy. In an aspect, a disclosed dose of abemaciclib can comprise about 100 mg to about 300 mg. In an aspect, the dose of abemaciclib can comprise about 150 mg. In an aspect, a disclosed dose of abemaciclib can comprise about 200 mg. In an aspect, a disclosed method can comprise modifying the dose of abemaciclib. In an aspect, modifying the dose of abemaciclib can comprise accelerating and / or increasing the dose of abemaciclib. In an aspect, modifying the dose of abemaciclib can comprise decreasing and / or reducing the dose of abemaciclib. In an aspect, modify ing the dose of abemaciclib can be based on the subject's tolerance of one or more prior doses. In an aspect, modifying the dose of abemaciclib can be based on the subject's development of one or more adverse events (e.g., hepatic toxicity and / or physiologic and / or metabolic perturbations) following of one or more prior doses. In an aspect, abemaciclib can be administered twice daily. In an aspect, a disclosed method can further comprise repeating the administering of abemaciclib. In an aspect, a disclosed method can further comprise repeating the administering of abemaciclib every7day for at least 1 year or repeating the administering of abemaciclib every7day for at least 2 years. In an aspect, a disclosed method can further comprise repeating the administering of abemaciclib until disease progression or until the subject demonstrates unacceptable toxicity. In an aspect, a disclosed method can further comprise observing the subject for a period following one or more administering steps. In an aspect, a disclosed observation period after administering abemaciclib can comprise at least 15 minutes, at least 30 minutes, at least 45 minutes, at least 60 minutes, at least 75 minutes, at least 90 minutes, or more than 90 minutes.In an aspect, a disclosed observation period can comprise about 30 minutes or about 90 minutes. In an aspect, a disclosed observation period can comprise 1 or more days, 2 or more days, 3 or more days, 4 or more days, 5 or more days, 6 or more days, 7 or more days, or more than 1 week, or more than 2 weeks, or more than 3 weeks, or more than 4 weeks, or 1 or more months.

[0246] ADO-TRASTUZUMAB EMTANSINE. In an aspect, a disclosed targeted therapy can comprise ado-trastuzumab emtansine. As described herein, ado-trastuzumab emtansine can be know n to the art. In an aspect of a disclosed method, administering ado-trastuzumab emtansine can comprise intravenous administration. In an aspect, ado-trastuzumab emtansine can be used alone (e.g., as a monotherapy). In an aspect, a disclosed dose of ado-trastuzumab emtansine can comprise about 3.0 mg / kg to about 4.0 mg / kg. In an aspect, a disclosed dose of ado- trastuzumab emtansine can comprise about 3.6 mg / kg. In an aspect, a disclosed dose of ado- trastuzumab emtansine does not exceed 3.6 mg / kg. In an aspect, a disclosed method can comprise modifying the dose of ado-trastuzumab emtansine. In an aspect, modifying the dose of ado-trastuzumab emtansine can comprise accelerating and / or increasing the dose of ado- trastuzumab emtansine. In an aspect, modifying the dose of ado-trastuzumab emtansine can comprise decreasing and / or reducing the dose of ado-trastuzumab emtansine. In an aspect, modifying the dose of ado-trastuzumab emtansine can be based on the subject's tolerance of one or more prior doses. In an aspect, modifying the dose of ado-trastuzumab emtansine can be based on the subject's development of one or more adverse events (e.g., hepatic toxicity and / or physiologic and / or metabolic perturbations) following of one or more prior doses. In an aspect, a disclosed first dose of ado-trastuzumab emtansine can be intravenously administered during about a 90-minute period. In an aspect, each additional and / or subsequent disclosed dose of ado-trastuzumab emtansine can be intravenously administered during about a 30-minute period. In an aspect, ado-trastuzumab emtansine can be administered intravenously administered every 3 weeks. In an aspect, ado-trastuzumab emtansine can be administered once during a 21 day or 3-week cycle. In an aspect, a disclosed method can further comprise repeating the administering of ado-trastuzumab emtansine. In an aspect, a disclosed method can further comprise repeating the administering of ado-trastuzumab emtansine for 14 cycles. In an aspect, a disclosed method can further comprise repeating the administering of ado-trastuzumab emtansine until disease progression or until the subject demonstrates unacceptable toxicity. In an aspect, a disclosed method can further comprise observing the subject for a period following one or more administering steps. In an aspect, a disclosed observation period after administering ado-trastuzumab emtansine can comprise atleast 15 minutes, at least 30 minutes, at least 45 minutes, at least 60 minutes, at least 75 minutes, at least 90 minutes, or more than 90 minutes. In an aspect, a disclosed observation period can comprise about 30 minutes or about 90 minutes. In an aspect, a disclosed observation period can comprise 1 or more days, 2 or more days, 3 or more days, 4 or more days, 5 or more days, 6 or more days, 7 or more days, or more than 1 week, or more than 2 weeks, or more than 3 weeks, or more than 4 weeks, or 1 or more months.

[0247] AFATINIB. In an aspect, a disclosed targeted therapy can comprise afatinib. As described herein, afatinib can be known to the art. In an aspect of a disclosed method, administering afatinib can comprise oral administration. In an aspect, oral administration can comprise a tablet taken with food or without food. In an aspect, oral administration does not comprise crushing, cutting, or chewing the capsule. In an aspect, oral administration can comprise swallowing the capsule whole. In an aspect, afatinib can be used alone (e.g., as a monotherapy). In an aspect, a disclosed dose of afatinib can comprise about 20 mg, about 30 mg, about 40 mg, about 50 mg, or about 60 mg. In an aspect, a disclosed dose of afatinib can comprise about 20 mg to about 60 mg. In an aspect, a disclosed dose of afatinib can comprise about 40 mg. In an aspect, a disclosed dose of afatinib can comprise two 20 mg tablets, three 20 mg tablets, three 20 mg tablets, one 30 mg tablet, two 30 mg tablets, one 40 mg tablet, or one 20 mg tablet and one 30 mg tablet. In an aspect, oral administration can comprise administering about 20 mg to about 60 mg afatinib once daily. In an aspect, oral administration can comprise administering about 40 mg afatinib once daily. In an aspect, a disclosed method can comprise modifying the dose of afatinib. In an aspect, modifying the dose of afatinib can comprise accelerating and / or increasing the dose of afatinib. In an aspect, modifying the dose of afatinib can comprise decreasing and / or reducing the dose of afatinib. In an aspect, modifying the dose of afatinib can be based on the subject's tolerance of one or more prior doses. In an aspect, modifying the dose of afatinib can be based on the subject's development of one or more adverse events (e.g., hepatic toxicity and / or physiologic and / or metabolic perturbations) following of one or more prior doses. In an aspect, a disclosed method can further comprise repeating the administering of afatinib. In an aspect, a disclosed method can further comprise repeating the administering of afatinib until disease progression or until the subject demonstrates unacceptable toxicity. In an aspect, a disclosed method can further comprise observing the subject for a period following one or more administering steps. In an aspect, a disclosed observation period after administering afatinib can comprise at least 15 minutes, at least 30 minutes, at least 45 minutes, at least 60 minutes, at least 75 minutes, at least 90 minutes, or more than 90 minutes. In an aspect, a disclosed observation period cancomprise about 30 minutes or about 90 minutes. In an aspect, a disclosed observation period can comprise 1 or more days, 2 or more days, 3 or more days. 4 or more days, 5 or more days, 6 or more days, 7 or more days, or more than 1 week, or more than 2 weeks, or more than 3 weeks, or more than 4 weeks, or 1 or more months.

[0248] ALECTINIB. In an aspect, a disclosed targeted therapy can comprise alectinib. As described herein, alectinib can be known to the art. In an aspect of a disclosed method, administering alectinib can comprise oral administration. In an aspect, oral administration can comprise a capsule taken with food. In an aspect, oral administration does not comprise crushing, cutting, or chewing the capsule. In an aspect, oral administration can comprise swallowing the capsule whole. In an aspect, alectinib can be used alone (e.g., as a monotherapy). In an aspect, a disclosed dose of alectinib can comprise about 550 mg to about 650 mg. In an aspect, a disclosed dose of alectinib can comprise about 600 mg. In an aspect, oral administration can comprise administering about 600 mg alectinib twice daily. In an aspect, a disclosed method can comprise modifying the dose of alectinib. In an aspect, modifying the dose of alectinib can comprise accelerating and / or increasing the dose of alectinib. In an aspect, modifying the dose of alectinib can comprise decreasing and / or reducing the dose of alectinib. In an aspect, modifying the dose of alectinib can be based on the subject's tolerance of one or more prior doses. In an aspect, modifying the dose of alectinib can be based on the subject's development of one or more adverse events (e g., hepatic toxicity and / or physiologic and / or metabolic perturbations) following of one or more prior doses. In an aspect, a disclosed method can further comprise repeating the administering of alectinib. In an aspect, a disclosed method can further comprise repeating the administering of alectinib until disease progression or until the subject demonstrates unacceptable toxicity. In an aspect, a disclosed method can further comprise observing the subject for a period following one or more administering steps. In an aspect, a disclosed observation period after administering alectinib can comprise at least 15 minutes, at least 30 minutes, at least 45 minutes, at least 60 minutes, at least 75 minutes, at least 90 minutes, or more than 90 minutes. In an aspect, a disclosed observation period can comprise about 30 minutes or about 90 minutes. In an aspect, a disclosed observation period can comprise 1 or more days, 2 or more days, 3 or more days. 4 or more days, 5 or more days, 6 or more days, 7 or more days, or more than 1 week, or more than 2 weeks, or more than 3 weeks, or more than 4 weeks, or 1 or more months.

[0249] ALEMTUZUMAB. In an aspect, a disclosed targeted therapy can comprise alemtuzumab. As described herein, alemtuzumab can be known to the art. In an aspect of a disclosed method, administering alemtuzumab can comprise intravenous administration. In anaspect, a disclosed dose of alemtuzumab can be intravenously administered during about a 3- hour period to about a 5-hour period. In an aspect, a disclosed dose of alemtuzumab can be intravenously administered during about a 4-hour period. In an aspect, a disclosed dose of alemtuzumab can be intravenously administered for 2 or more treatment courses. In an aspect, a disclosed dose of alemtuzumab can comprise about 9 mg to about 15 mg. In an aspect, a disclosed dose of alemtuzumab can comprise about 12 mg. In an aspect of a disclosed method, alemtuzumab can be intravenously administered on consecutive days. In an aspect, a disclosed targeted therapy can comprise multiple courses of treatment. In an aspect, a disclosed initial treatment of 2 courses can comprise a first course comprising 12 mg / day alemtuzumab administered on 5 consecutive days, and a second course comprising 12 mg / day alemtuzumab on 3 consecutive days, wherein the second course commences 12 months after the first course. In an aspect, a disclosed subsequent course of treatment can comprise about 12 mg alemtuzumab per day on 3 consecutive days, and wherein the subsequent course of treatment commences 12 months after the last dose of a prior course of treatment. In an aspect, a disclosed first course of treatment can comprise a total dose of about 60 mg alemtuzumab. In an aspect, a disclosed subsequent course of treatment can comprise a total dose of about 36 mg alemtuzumab. In an aspect of a disclosed method, about 12 mg alemtuzumab can be intravenously administered on 5 consecutive days. In an aspect, a disclosed method can further comprise administering a high dose of corticosteroid immediately prior to the intravenous administration of alemtuzumab. In an aspect, a disclosed method can further comprise administering a high dose of corticosteroid immediately prior to the intravenous administration of alemtuzumab on each of the first 3 days of a treatment course. In an aspect, a disclosed high dose of corticosteroids can comprise about 800 mg to about 1200 mg methylprednisolone or an equivalent thereof. In an aspect, a disclosed high dose of corticosteroids can comprise about 1000 mg methylprednisolone or an equivalent thereof. In an aspect, a disclosed method can further comprise repeating the administering of alemtuzumab. In an aspect, a disclosed each additional dose of alemtuzumab can be intravenously administered during about a 4-hour period. In an aspect, a disclosed method can further comprise repeating the administering of alemtuzumab until disease progression or until the subject demonstrates unacceptable toxicity. In an aspect, a disclosed method can further comprise observing the subject for a period following one or more administering steps. In an aspect, a disclosed observation period after administering alemtuzumab can comprise at least 15 minutes, at least 30 minutes, at least 45 minutes, at least 60 minutes, at least 75 minutes, at least 90 minutes, or more than 90 minutes. In an aspect, a disclosed observation period can comprise about 30 minutes or about 90minutes. In an aspect, a disclosed observation period can comprise 1 or more days, 2 or more days. 3 or more days, 4 or more days, 5 or more days, 6 or more days, 7 or more days, or more than 1 week, or more than 2 weeks, or more than 3 weeks, or more than 4 weeks, or 1 or more months.

[0250] ALPELISIB. In an aspect, a disclosed targeted therapy can comprise alpelisib. As described herein, alpelisib can be known to the art. In an aspect of a disclosed method, administering alpelisib can comprise oral administration. In an aspect, oral administration can comprise atablet taken with food. In an aspect, oral administration does not comprise crushing, cutting, or chewing the tablet. In an aspect, oral administration can comprise swallowing the tablet whole. In an aspect, alpelisib can be used alone (e.g., as a monotherapy). In an aspect, a disclosed dose of alpelisib can comprise about 200 mg to about 300 mg for an adult subject. In an aspect, a disclosed dose of alpelisib can comprise about 250 mg for an adult subject. In an aspect, a disclosed dose of alpelisib can comprise about 25 mg to about 75 mg for a pediatric subject. In an aspect, a disclosed dose of alpelisib can comprise about 50 mg for a pediatric subject. In an aspect, oral administration can comprise administering about 250 mg alpelisib once daily. In an aspect, a disclosed oral administration can comprise administering about 50 mg alpelisib once daily. In an aspect, a disclosed method can comprise modifying the dose of alpelisib. In an aspect, modifying the dose of alpelisib can comprise accelerating and / or increasing the dose of alpelisib. In an aspect, modifying the dose of alpelisib can comprise decreasing and / or reducing the dose of alpelisib. In an aspect, modifying the dose of alpelisib can be based on the subject's tolerance of one or more prior doses. In an aspect, modifying the dose of alpelisib can be based on the subject's development of one or more adverse events (e.g., hepatic toxicity and / or physiologic and / or metabolic perturbations) following of one or more prior doses. In an aspect, a disclosed method can further comprise repeating the administering of alpelisib. In an aspect, a disclosed method can further comprise repeating the administering of alpelisib until disease progression or until the subject demonstrates unacceptable toxicity. In an aspect, a disclosed method can further comprise observing the subject for a period following one or more administering steps. In an aspect, a disclosed observation period after administering alpelisib can comprise at least 15 minutes, at least 30 minutes, at least 45 minutes, at least 60 minutes, at least 75 minutes, at least 90 minutes, or more than 90 minutes. In an aspect, a disclosed observation period can comprise about 30 minutes or about 90 minutes. In an aspect, a disclosed observation period can comprise 1 or more days, 2 or more days. 3 or more days, 4 or more days, 5 or more days, 6 or more days, 7 or more days, or morethan 1 week, or more than 2 weeks, or more than 3 weeks, or more than 4 weeks, or 1 or more months.

[0251] ATEZOLIZUMAB. In an aspect, a disclosed targeted therapy can comprise atezolizumab. As described herein, atezolizumab can be known to the art. In an aspect of a disclosed method, administering atezolizumab can comprise intravenous administration. In an aspect, a disclosed dose of atezolizumab can be intravenously administered during about a 60- minute period. In an aspect, a disclosed dose of atezolizumab can comprise about 800 mg to about 880 mg, about 1100 mg to about 1300 mg, or about 1600 mg to about 1800 mg. In an aspect, a disclosed dose of atezolizumab can comprise about 840 mg every 2 weeks, about 1200 mg every 3 weeks, or about 1680 mg every 4 weeks for ayear. In an aspect, atezolizumab can be used in combination with chemotherapy with or without bevacizumab. In an aspect, bevacizumab can be administered at about 15 mg / kg every 3 w eeks. In an aspect, atezolizumab can be administered prior to chemotherapy when administered on the same day. In an aspect, atezolizumab can be used in combination with carboplatin and etoposide. In an aspect, atezolizumab can be used in combination with cobimetinib and vemurafenib. In an aspect, cobimetimb can be administered at about 60 mg orally once daily and wherein vemurafenib can be administered at about 720 mg orally twice daily as part of a 28-day cycle. In an aspect, each additional and / or subsequent disclosed dose of atezolizumab can be intravenously administered during about a 30-minute period. In an aspect, a disclosed method can comprise modifying the dose of atezolizumab. In an aspect, modifying the dose of atezolizumab can comprise accelerating and / or increasing the dose of atezolizumab. In an aspect, modifying the dose of atezolizumab can comprise decreasing and / or reducing the dose of atezolizumab. In an aspect, modifying the dose of atezolizumab can be based on the subject's tolerance of one or more prior doses. In an aspect, modifying the dose of atezolizumab can be based on the subject's development of one or more adverse events (e.g., hepatic toxicity and / or physiologic and / or metabolic perturbations) following of one or more prior doses. In an aspect, a disclosed method can further comprise repeating the administering of atezolizumab. In an aspect, each additional disclosed dose of atezolizumab can be intravenously administered during about a 30-minute period. In an aspect, a disclosed method can further comprise repeating the administering of atezolizumab for at least 1 year. In an aspect, a disclosed method can further comprise repeating the administering of atezolizumab until disease progression or until the subject demonstrates unacceptable toxicity. In an aspect, a disclosed method can further comprise observing the subject for a period following one or more administering steps. In an aspect, a disclosed observation period after administering atezolizumab can comprise at least15 minutes, at least 30 minutes, at least 45 minutes, at least 60 minutes, at least 75 minutes, at least 90 minutes, or more than 90 minutes. In an aspect, a disclosed observation period can comprise about 30 minutes or about 90 minutes. In an aspect, a disclosed observation period can comprise 1 or more days, 2 or more days, 3 or more days, 4 or more days, 5 or more days, 6 or more days, 7 or more days, or more than 1 week, or more than 2 weeks, or more than 3 weeks, or more than 4 weeks, or 1 or more months.

[0252] AVELUMAB. In an aspect, a disclosed targeted therapy can comprise avelumab. As described herein, avelumab can be known to the art. In an aspect of a disclosed method, administering avelumab can comprise intravenous administration. In an aspect, a disclosed dose of avelumab can be intravenously administered during about a 30-minute period to about a 90-minute period. In an aspect, a disclosed dose of avelumab can be intravenously administered during about a 60-minute period. In an aspect, a disclosed dose of avelumab can comprise about 700 mg to about 750 mg, about 750 mg to about 800 mg, about 800 mg to about 850 mg, or about 850 mg to about 900 mg. In an aspect, a disclosed dose of avelumab can comprise about 800 mg. In an aspect, a disclosed dose of about 800 mg avelumab can be intravenously administered every 2 weeks. In an aspect, avelumab can be used in combination with axitinib. In an aspect, avelumab can be administered every 2 weeks in combination with axitinib administered twice daily. In an aspect, two daily disclosed doses of axitinib are administered about 12 hours apart. In an aspect, a disclosed dose of axitinib can be escalated. In an aspect, a disclosed dose of axitinib can comprise about 5 mg. about 7.5 mg, or about 10 mg. In an aspect, a disclosed total daily dose can comprise about 10 mg, about 15 mg, or about 20 mg axitinib. wherein about 800 mg avelumab can be intravenously administered every 2 weeks in combination with about 5 mg axitinib orally administered twice daily. In an aspect, a disclosed method can further comprise administering an antihistamine and acetaminophen prior to the intravenous administration of avelumab. In an aspect, a disclosed antihistamine and a disclosed acetaminophen can be administered prior to the intravenous administration of avelumab for each of the first 4 infusions. In an aspect, a disclosed method can comprise modifying the dose of avelumab. In an aspect, modifying the dose of avelumab can comprise accelerating and / or increasing the dose of avelumab. In an aspect, modifying the dose of avelumab can comprise decreasing and / or reducing the dose of avelumab. In an aspect, modifying the dose of avelumab can be based on the subject's tolerance of one or more prior doses. In an aspect, modify ing the dose of avelumab can be based on the subject's development of one or more adverse events (e.g.. hepatic toxicity and / or physiologic and / or metabolic perturbations) following of one or more prior doses. In an aspect, a disclosed method canfurther comprise repeating the administering of avelumab. In an aspect, each disclosed additional dose of avelumab can be intravenously administered during about a 60-minute period. In an aspect, a disclosed method can further comprise repeating the administering of avelumab for at least 1 year. In an aspect, a disclosed method can further comprise repeating the administering of avelumab until disease progression or until the subject demonstrates unacceptable toxicity. In an aspect, a disclosed method can further comprise observing the subject for a period following one or more administering steps. In an aspect, a disclosed observation period after administering avelumab can comprise at least 15 minutes, at least 30 minutes, at least 45 minutes, at least 60 minutes, at least 75 minutes, at least 90 minutes, or more than 90 minutes. In an aspect, a disclosed observation period can comprise about 30 minutes or about 90 minutes. In an aspect, a disclosed observation period can comprise 1 or more days, 2 or more days, 3 or more days, 4 or more days, 5 or more days, 6 or more days, 7 or more days, or more than 1 week, or more than 2 weeks, or more than 3 weeks, or more than 4 weeks, or 1 or more months.

[0253] AXITINIB. In an aspect, a disclosed targeted therapy can comprise axitinib. As described herein, axitinib can be known to the art. In an aspect of a disclosed method, administering axitinib can comprise oral administration. In an aspect, oral administration can comprise a tablet taken with or without food. In an aspect, oral administration does not comprise crushing, cutting, or chewing the tablet. In an aspect, oral administration can comprise swallowing the tablet whole. In an aspect, oral administration can comprise swallowing axitinib with a glass of water. In an aspect, axitinib can be used alone (e.g., as a monotherapy). In an aspect, a disclosed dose of axitinib can comprise about 5 mg orally twice daily. In an aspect, a disclosed dose of axitinib can comprise about 5 mg, about 6 mg, about 7 mg, about 8 mg, about 9 mg, or about 10 mg orally twice daily. In an aspect, axitinib can be used in combination with avelumab. In an aspect, about 5 mg axitinib can be orally administered twice daily with about 800 mg avelumab administered every 2 weeks. In an aspect, about 5 mg axitinib can be orally administered twice daily with about 200 mg pembrolizumab administered every 3 weeks or with about 400 mg pembrolizumab administered every 6 weeks. In an aspect, oral administration can comprise administering about 5 mg axitinib twice daily. In an aspect, oral administration can comprise administering about 10 mg axitinib twice daily. In an aspect, a disclosed total daily dose of axitinib can comprise about 5 g to about 25 mg. In an aspect, a disclosed total daily dose of axitinib can comprise about 5 g to about 10 g, about 10 g to about 15 g, about 15 g to about 20 g, and about 20 g to about 25 mg. In an aspect, a disclosed method can comprise modifying the dose ofaxitinib. In an aspect, modifying the dose of axitinib can comprise accelerating and / or increasing the dose of axitinib. In an aspect, modifying the dose of axitinib can comprise decreasing and / or reducing the dose of axitinib. In an aspect, modifying the dose of axitinib can be based on the subject's tolerance of one or more prior doses. In an aspect, modifying the dose of axitinib can be based on the subject's development of one or more adverse events (e.g., hepatic toxicity and / or physiologic and / or metabolic perturbations) following of one or more prior doses. In an aspect, a disclosed method can further comprise repeating the administering of axitinib. In an aspect, a disclosed method can further comprise repeating the administering of axitinib until disease progression or until the subject demonstrates unacceptable toxicity. In an aspect, a disclosed method can further comprise observing the subject for a period following one or more administering steps. In an aspect, a disclosed observation period after administering axitinib can comprise at least 15 minutes, at least 30 minutes, at least 45 minutes, at least 60 minutes, at least 75 minutes, at least 90 minutes, or more than 90 minutes. In an aspect, a disclosed observation period can comprise about 30 minutes or about 90 minutes. In an aspect, a disclosed observation period can comprise 1 or more days, 2 or more days, 3 or more days. 4 or more days, 5 or more days, 6 or more days. 7 or more days, or more than 1 week, or more than 2 weeks, or more than 3 weeks, or more than 4 weeks, or 1 or more months.

[0254] BEVACIZUMAB. In an aspect, a disclosed targeted therapy can comprise bevacizumab. As described herein, bevacizumab can be known to the art. In an aspect of a disclosed method, administering bevacizumab can comprise intravenous administration. In an aspect, a disclosed first dose of bevacizumab can be intravenously administered during about a 90-minute period. In an aspect, a disclosed dose of bevacizumab can comprise about 5 mg / kg, about 10 mg / kg, about 15 mg / kg, or about 20 mg / kg administered intravenously. In an aspect, bevacizumab can be used in combination with bolus-intravenous fluorouracil-based chemotherapy. In an aspect, about 5 mg / kg bevacizumab can be administered every 2 weeks in combination with bolus-intravenous fluorouracil-based chemotherapy. In an aspect, bevacizumab can be used in combination with FOLFOX4. In an aspect, about 10 mg / kg bevacizumab can be administered every 2 weeks in combination w ith FOLFOX4. In an aspect, bevacizumab can be used in combination with fluoropyrimidine-irinotecan-based chemotherapy or fluoropyrimidine-oxaliplatin-based chemotherapy. In an aspect, about 5 mg / kg bevacizumab can be administered every' 2 weeks in combination with fluoropyrimidine- irinotecan-based chemotherapy or fluoropyrimidine-oxaliplatin-based chemotherapy. In an aspect, about 7.5 mg / kg bevacizumab can be administered every 3 weeks in combination with fluoropyrimidine-irinotecan-based chemotherapy or fluoropyrimidine-oxaliplatin-basedchemotherapy. In an aspect, bevacizumab can be used in combination with carboplatin and paclitaxel. In an aspect, about 15 mg / kg bevacizumab can be administered every 3 weeks in combination with carboplatin and paclitaxel. In an aspect, bevacizumab can be used in combination with interferon alfa. In an aspect, about 10 mg / kg bevacizumab can be administered every 2 weeks in combination with interferon alfa. In an aspect, bevacizumab can be used in combination with paclitaxel and cisplatin or with paclitaxel and topotecan. In an aspect, about 15 mg / kg bevacizumab can be administered every 3 weeks in combination with carboplatin and paclitaxel for up to 6 cycles. In an aspect, bevacizumab can be used in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan. In an aspect, about 10 mg / kg bevacizumab can be administered every 2 weeks in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan (administered every week). In an aspect, about 15 mg / kg bevacizumab can be administered every 3 weeks in combination with topotecan (administered every 3 w eeks). In an aspect, bevacizumab can be used in combination with carboplatin and paclitaxel. In an aspect, about 15 mg / kg bevacizumab can be administered every 3 weeks in combination with carboplatin and paclitaxel for 6 to 8 cycles. In an aspect, bevacizumab can be used in combination with carboplatin and gemcitabine. In an aspect, about 15 mg / kg bevacizumab can be administered every 3 weeks in combination with carboplatin and gemcitabine for 6 to 10 cycles. In an aspect, bevacizumab can be used in combination with atezolizumab. In an aspect, about 15 mg / kg bevacizumab can be administered with about 1200 mg atezolizumab on the same day for every 3 weeks. In an aspect, each additional and / or subsequent disclosed dose of bevacizumab can be intravenously administered during about a 60-minute period or about a 30-minute period. In an aspect, a disclosed method can comprise modifying the dose of bevacizumab. In an aspect, modifying the dose of bevacizumab can comprise accelerating and / or increasing the dose of bevacizumab. In an aspect, modifying the dose of bevacizumab can comprise decreasing and / or reducing the dose of bevacizumab. In an aspect, modifying the dose of bevacizumab can be based on the subject's tolerance of one or more prior doses. In an aspect, modifying the dose of bevacizumab can be based on the subject's development of one or more adverse events (e g., hepatic toxicity and / or physiologic and / or metabolic perturbations) following of one or more prior doses. In an aspect, a disclosed method can further comprise repeating the administering of bevacizumab. In an aspect, a disclosed second dose of bevacizumab can be intravenously administered during about a 60- minute period. In an aspect, each additional disclosed dose of bevacizumab can be intravenously administered during about a 30-minute period. In an aspect, a disclosed method can further comprise repeating the administering of bevacizumab for at least 1 year. In anaspect, a disclosed method can further comprise repeating the administering of bevacizumab until disease progression or until the subject demonstrates unacceptable toxicity. In an aspect, a disclosed method can further comprise observing the subject for a period following one or more administering steps. In an aspect, a disclosed observation period after administering bevacizumab can comprise at least 15 minutes, at least 30 minutes, at least 45 minutes, at least 60 minutes, at least 75 minutes, at least 90 minutes, or more than 90 minutes. In an aspect, a disclosed observation period can comprise about 30 minutes or about 90 minutes. In an aspect, a disclosed observation period can comprise 1 or more days, 2 or more days, 3 or more days, 4 or more days, 5 or more days, 6 or more days, 7 or more days, or more than 1 week, or more than 2 weeks, or more than 3 weeks, or more than 4 weeks, or 1 or more months.

[0255] BINIMETINIB. In an aspect, a disclosed targeted therapy can comprise binimetinib. As described herein, binimetinib can be known to the art. In an aspect of a disclosed method, administering binimetinib can comprise oral administration. In an aspect, oral administration can comprise a tablet taken with or without food. In an aspect, oral administration does not comprise crushing, cutting, or chewing the tablet. In an aspect, oral administration can comprise swallowing the tablet whole. In an aspect, binimetinib can be used alone (e.g., as a monotherapy). In an aspect, binimetinib can comprise about 30 mg to about 60 mg. In an aspect, binimetinib can comprise about 45 mg. In an aspect, oral administration can comprise administering about 45 mg binimetinib twice daily. In an aspect, oral administration can comprise administering about 45 mg binimetinib twice daily about 12 hours apart. In an aspect, a disclosed dose of 45 mg binimetinib can comprise three 15 mg tablets. In an aspect, binimetinib can be administered with encorafenib. In an aspect, a disclosed method can comprise modifying the dose of binimetinib. In an aspect, modifying the dose of binimetinib can comprise accelerating and / or increasing the dose of binimetinib. In an aspect, modifying the dose of binimetinib can comprise decreasing and / or reducing the dose of binimetinib. In an aspect, modifying the dose of binimetinib can be based on the subject's tolerance of one or more prior doses. In an aspect, modifying the dose of binimetinib can be based on the subject's development of one or more adverse events (e.g., hepatic toxicity and / or physiologic and / or metabolic perturbations) following of one or more prior doses. In an aspect, a disclosed method can further comprise repeating the administering of binimetinib. In an aspect, a disclosed method can further comprise repeating the administering of binimetinib until disease progression or until the subject demonstrates unacceptable toxicity. In an aspect, a disclosed method can further comprise observing the subject for a period following one or more administering steps. In an aspect, a disclosed observation period after administeringbinimetinib can comprise at least 15 minutes, at least 30 minutes, at least 45 minutes, at least 60 minutes, at least 75 minutes, at least 90 minutes, or more than 90 minutes. In an aspect, a disclosed observation period can comprise about 30 minutes or about 90 minutes. In an aspect, a disclosed observation period can comprise 1 or more days, 2 or more days, 3 or more days, 4 or more days, 5 or more days, 6 or more days, 7 or more days, or more than 1 week, or more than 2 weeks, or more than 3 weeks, or more than 4 weeks, or 1 or more months.

[0256] BLINATUMOMAB. In an aspect, a disclosed targeted therapy can comprise blinatumomab. As described herein, blinatumomab can be known to the art. In an aspect of a disclosed method, administering blinatumomab can comprise intravenous administration. In an aspect, blinatumomab can be used alone (e g., as a monotherapy). In an aspect, blinatumomab can be administered in one or more treatment cycles. In an aspect, a disclosed treatment can comprise an induction cycle. In an aspect, a disclosed treatment can comprise a consolidation cycle. In an aspect, a disclosed induction cycle can comprise 28 days of continuous intravenous infusion of blinatumomab. In an aspect, a disclosed 28-day induction cycle can be followed by 14 days of no treatment. In an aspect, a disclosed 42-day cycle can comprise 28 days of continuous intravenous infusion of blinatumomab and 14 days of no treatment. In an aspect, a disclosed dose of blinatumomab can comprise about 25 mcg / day to about 30 mcg for a subject weighing at least 45 kg. In an aspect, a disclosed dose of blinatumomab can comprise about 28 mcg / day for a subject weighing at least 45 kg. In an aspect, a disclosed dose of blinatumomab can comprise about 25 mcg / day to about 30 mcg for a subject weighing at least 45 kg for 28 days in the induction cycle. In an aspect, a disclosed dose of blinatumomab can comprise about 28 mcg / day for a subject weighing at least 45 kg for 28 days in the induction cycle. In an aspect, a disclosed dose of blinatumomab can comprise about 12 mcg / m2 / day to about 18 mcg / m2 / day for a subject weighing less than 45 kg. In an aspect, a disclosed dose of blinatumomab can comprise about 15 mcg / m2 / day for a subject weighing less than 45 kg. In an aspect, a disclosed dose of blinatumomab can comprise about 12 mcg / m2 / day to about 18 mcg / m2 / day for a subject weighing less than 45 kg for 28 days in the induction cycle. In an aspect, a disclosed dose of blinatumomab can comprise about 15 mcg / m2 / day for a subject weighing less than 45 kg for 28 days in the induction cycle. In an aspect, a disclosed dose of blinatumomab can comprise about 25 mcg / day to about 30 mcg for a subject weighing at least 45 kg for 28 days in each consolidation cycle. In an aspect, a disclosed dose of blinatumomab can comprise about 28 mcg / day for a subject weighing at least 45 kg for 28 days in each consolidation cycle. In an aspect, a disclosed dose of blinatumomab can comprise about 12 mcg / m2 / day to about 18 mcg / m2 / day for a subject weighing less than45 kg for 28 days in each consolidation cycle. In an aspect, a disclosed dose of blinatumomab can comprise about 15 mcg / m2 / day for a subject weighing less than 45 kg for 28 days in each consolidation cycle. In an aspect, days 29-42 of a disclosed induction cycle are treatment-free. In an aspect, a disclosed dose of blinatumomab does not exceed 28 mcg per day. In an aspect, a disclosed method can further comprise intravenously administering to an adult subject about 100 mg prednisone or about 16 mg dexamethasone about 60 minutes prior to the first dose of blinatumomab in each cycle. In an aspect, a disclosed method can further comprise intravenously administering to a pediatric subject about 5 mg / m2dexamethasone prior to the first dose of blinatumomab in each cycle. In an aspect, a disclosed method can further comprise intravenously administering to a pediatric subject about 5 mg / m2dexamethasone prior to restarting an infusion after an interruption of 4 or more hours in the first cycle. In an aspect, a disclosed dose of dexamethasone administered to a pediatric subject does not exceed 20 mg. In an aspect, a disclosed treatment course of blinatumomab can comprise 1 induction cycle and up to 3 consolidation cycles. In an aspect, a disclosed method can further comprise hospitalizing the subject for the first 3 days of the induction c cle and the first 2 days of the first consolidation cycle. In an aspect, a disclosed dose of blinatumomab can comprise about6 mcg / day to about 12 mcg for a subject weighing at least 45 kg. In an aspect, a disclosed dose of blinatumomab can comprise about 9 mcg / day for a subject weighing at least 45 kg. In an aspect, a disclosed dose of blinatumomab can comprise about 6 mcg / day to about 12 mcg for a subject weighing at least 45 kg for 7 days in the first induction cycle. In an aspect, a disclosed dose of blinatumomab can comprise about 9 mcg / day for a subject weighing at least 45 kg for7 days in the first induction cycle. In an aspect, a disclosed dose of blinatumomab can comprise about 25 mcg / day to about 30 mcg for a subject weighing at least 45 kg. In an aspect, a disclosed dose of blinatumomab can comprise about 28 mcg / day for a subject weighing at least 45 kg. In an aspect, a disclosed dose of blinatumomab can comprise about 25 mcg / day to about 30 mcg for a subject weighing at least 45 kg for day 8 through day 28 in the first induction cycle. In an aspect, a disclosed dose of blinatumomab can comprise about 28 mcg / day for a subject weighing at least 45 kg for day 8 through day 28 in the first induction cycle. In an aspect, a disclosed dose of blinatumomab can comprise about 25 mcg / day to about 30 mcg for a subject weighing at least 45 kg for day 1 through day 28 in the second induction cycle. In an aspect, a disclosed dose of blinatumomab can comprise about 28 mcg / day for a subject weighing at least 45 kg for day 1 through day 28 in the second induction cycle. In an aspect, a disclosed dose of blinatumomab can comprise about 25 mcg / day to about 30 mcg for a subject weighing at least 45 kg for day 1 through day 28 in each of consolidation cycle 3 throughconsolidation cycle 5. In an aspect, a disclosed dose of blinatumomab can comprise about 28 mcg / day for a subject weighing at least 45 kg for day 1 through day 28 in each of consolidation cycle 3 through consolidation cycle 5. In an aspect, a disclosed dose of blinatumomab can comprise about 25 mcg / day to about 30 mcg for a subject weighing at least 45 kg for day 1 through day 28 in each of continued therapy cycle 6 through continued therapy cycle 9. In an aspect, a disclosed dose of blinatumomab can comprise about 28 mcg / day for a subject weighing at least 45 kg for day 1 through day 28 in each of continued therapy cycle 6 through continued therapy cycle 9. In an aspect, a disclosed dose of blinatumomab can comprise about 3 mcg / m2 / day to about 7 mcg / m2 / day for a subject weighing less than 45 kg. In an aspect, a disclosed dose of blinatumomab can comprise about 5 mcg / m2 / day for a subject weighing less than 45 kg. In an aspect, a disclosed dose of blinatumomab can comprise about 3 mcg / m2 / day to about 7 mcg / m2 / day for a subject weighing less than 45 kg for 7 days in the first induction cycle. In an aspect, a disclosed dose of blinatumomab can comprise about 5 mcg / m2 / day for a subject weighing less than 45 kg for 7 days in the first induction cycle. In an aspect, a disclosed dose of blinatumomab can comprise about 12 mcg / m2 / day to about 18 mcg / m2 / day for a subject weighing less than 45 kg. In an aspect, a disclosed dose of blinatumomab can comprise about 15 mcg / m2 / day for a subject weighing less than 45 kg. In an aspect, a disclosed dose of blinatumomab can comprise about 12 mcg / m2 / day to about 18 mcg / m2 / day for a subject weighing less than 45 kg for day 8 through day 28 in the first induction cycle. In an aspect, a disclosed dose of blinatumomab can comprise about 15 mcg / m2 / day for a subject weighing less than 45 kg for day 8 through day 28 in the first induction cycle. In an aspect, a disclosed dose of blinatumomab can comprise about 12 mcg / m2 / day to about 18 mcg / m2 / day for a subject weighing less than 45 kg for day 1 through day 28 in the second induction cycle. In an aspect, a disclosed dose of blinatumomab can comprise about 15 mcg / m2 / day for a subject weighing less than 45 kg for day 1 through day 28 in the second induction cycle. In an aspect, a disclosed dose of blinatumomab can comprise about 12 mcg / m2 / day to about 18 mcg / m2 / day for asubject weighing less than 45 kg for day 1 through day 28 in each of consolidation cycle 3 through consolidation cycle 5. In an aspect, a disclosed dose of blinatumomab can comprise about 15 mcg / m2 / day for a subject weighing less than 45 kg for day I through day 28 in each of consolidation cycle 3 through consolidation cycle 5. In an aspect, a disclosed dose of blinatumomab can comprise about 12 mcg / m2 / day to about 18 mcg / m2 / day for a subject weighing less than 45 kg for day 1 through day 28 in each of continued therapy cycle 6 through continued therapy cycle 9. In an aspect, a disclosed dose of blinatumomab can comprise about 15 mcg / m2 / day for a subject weighing less than 45 kg for day 1 through day 28 in each ofcontinued therapy cycle 6 through continued therapy cycle 9. In an aspect, day 29 through day 42 in the first induction cycle are treatment free. In an aspect, day 29 through day 42 in the second induction cycle are treatment free. In an aspect, day 29 through day 42 in each of consolidation cycle 3 through consolidation cycle 5 are treatment free. In an aspect, day 29 through day 84 in each of continued therapy cycle 6 through continued therapy cycle 9 are treatment free. In an aspect, a disclosed method can further comprise intravenously administering to an adult subject about 20 mg dexamethasone about 60 minutes prior to the first dose of blinatumomab in each cycle, prior to a step dose, and when restarting an infusion after an interruption of 4 or more hours. In an aspect, a disclosed method can further comprise intravenously administering to a pediatric subject about 5 mg / m2dexamethasone prior to the first dose of blinatumomab prior to the first dose of blinatumomab in each cycle, prior to a step dose, and when restarting an infusion after an interruption of 4 or more hours. In an aspect, a disclosed dose of dexamethasone administered to a pediatric subject does not exceed 20 mg. In an aspect, a disclosed method can further comprise hospitalizing the subject for the first 3 days of the induction cycle and the first 2 days of the first consolidation cycle. In an aspect, a disclosed method can further comprise hospitalizing the subject for the first 9 days of the induction cycle and the first 2 days of the second induction cycle. In an aspect, a disclosed method can comprise modifying the dose of blinatumomab. In an aspect, modifying the dose of blinatumomab can comprise accelerating and / or increasing the dose of blinatumomab. In an aspect, modifying the dose of blinatumomab can comprise decreasing and / or reducing the dose of blinatumomab. In an aspect, modifying the dose of blinatumomab can be based on the subject's tolerance of one or more prior doses. In an aspect, modifying the dose of blinatumomab can be based on the subject's development of one or more adverse events (e.g., hepatic toxicity and / or physiologic and / or metabolic perturbations) following of one or more prior doses. In an aspect, a disclosed method can further comprise repeating the administering of blinatumomab until disease progression or until the subject demonstrates unacceptable toxicity. In an aspect, a disclosed method can further comprise observing the subject for a period following one or more administering steps. In an aspect, a disclosed observation period after administering blinatumomab can comprise at least 15 minutes, at least 30 minutes, at least 45 minutes, at least 60 minutes, at least 75 minutes, at least 90 minutes, or more than 90 minutes. In an aspect, a disclosed observation period can comprise about 30 minutes or about 90 minutes. In an aspect, a disclosed observation period can comprise 1 or more days, 2 or more days. 3 or more days, 4 or more days, 5 or more days, 6 or more days. 7 or more days, ormore than 1 week, or more than 2 weeks, or more than 3 weeks, or more than 4 weeks, or 1 or more months.

[0257] BOSUTINIB. In an aspect, a disclosed targeted therapy can comprise bosutinib. As described herein, bosutinib can be known to the art. In an aspect of a disclosed method, administering bosutinib can comprise oral administration. In an aspect, oral administration can comprise a tablet taken with or without food. In an aspect, oral administration does not comprise crushing, cutting, or chewing the tablet. In an aspect, oral administration can comprise swallowing the tablet whole. In an aspect, bosutinib can be used alone (e.g., as a monotherapy). In an aspect, a disclosed dose of bosutinib can comprise about 300 mg to about 600 mg. In an aspect, a disclosed dose of bosutinib can comprise about 400 mg or about 500 mg. In an aspect, oral administration can comprise administering about 400 mg bosutinib once daily with food. In an aspect, oral administration can comprise administering about 500 mg bosutinib once daily w ith food. In an aspect, a disclosed dose of bosutinib can be escalated but does not exceed 600 mg bosutinib daily. In an aspect, a disclosed 400 mg dose of bosutinib can comprise four 100 mg tablets or one 400 mg tablet. In an aspect, a disclosed 500 mg dose of bosutinib can comprise five 100 mg tablets or one 500 mg tablet. In an aspect, a disclosed 600 mg dose of bosutinib can comprise six 100 mg tablets or one 400 mg tablet and two 200 mg tablets. In an aspect, a disclosed method can comprise modifying the dose of bosutinib. In an aspect, modifying the dose of bosutinib can comprise accelerating and / or increasing the dose of bosutinib. In an aspect, modifying the dose of bosutinib can comprise decreasing and / or reducing the dose of bosutinib. In an aspect, modifying the dose of bosutinib can be based on the subject's tolerance of one or more prior doses. In an aspect, modifying the dose of bosutinib can be based on the subject's development of one or more adverse events (e g., hepatic toxicity and / or physiologic and / or metabolic perturbations) following of one or more prior doses. In an aspect, a disclosed method can further comprise repeating the administering of bosutinib until disease progression or until the subject demonstrates unacceptable toxicity. In an aspect, a disclosed method can further comprise observing the subject for a period following one or more administering steps. In an aspect, a disclosed observation period after administering bosutinib can comprise at least 15 minutes, at least 30 minutes, at least 45 minutes, at least 60 minutes, at least 75 minutes, at least 90 minutes, or more than 90 minutes. In an aspect, a disclosed observation period can comprise about 30 minutes or about 90 minutes. In an aspect, a disclosed observation period can comprise 1 or more days, 2 or more days, 3 or more days, 4 or more days, 5 or more days. 6 or more days, 7 or more days, or more than 1 week, or more than 2 weeks, or more than 3 weeks, or more than 4 weeks, or 1 or more months.

[0258] BRENTUXIMAB VEDOTIN. In an aspect, a disclosed targeted therapy can comprise brentuximab vedotin. As described herein, brentuximab vedotin can be known to the art. In an aspect of a disclosed method, administering brentuximab vedotin can comprise intravenous administration. In an aspect, a disclosed dose of brentuximab vedotin can be intravenously administered during about a 20-minute period to about a 40-minute period. In an aspect, a disclosed dose of brentuximab vedotin can be intravenously administered during about a 30- minute period. In an aspect, a disclosed dose of brentuximab vedotin can comprise 1.2 mg / kg intravenously administered in combination with chemotherapy. In an aspect, a disclosed dose of brentuximab vedotin can comprise 1.2 mg / kg intravenously administered every7two weeks in combination with chemotherapy. In an aspect, a disclosed maximum dose of brentuximab vedotin can comprise up to 120 mg. In an aspect, brentuximab vedotin can be intravenously administered every two weeks for upto 12 doses. In an aspect, a disclosed dose of brentuximab vedotin can comprise 1.2 mg / kg intravenously administered in combination with chemotherapy. In an aspect, a disclosed dose of brentuximab vedotin can comprise 1.2 mg / kg intravenously administered every two weeks in combination with chemotherapy. In an aspect, a disclosed maximum dose of brentuximab vedotin can comprise up to 120 mg. In an aspect, brentuximab vedotin can be intravenously administered every two weeks for up to 12 doses. In an aspect, brentuximab vedotin can be used in combination with chemotherapy. In an aspect, a disclosed dose of brentuximab vedotin can comprise 1.8 mg / kg intravenously administered in combination with chemotherapy. In an aspect, a disclosed dose of brentuximab vedotin can comprise 1.8 mg / kg intravenously administered every three weeks in combination with each cycle of chemotherapy. In an aspect, a disclosed maximum dose of brentuximab vedotin can comprise up to 180 mg. In an aspect, brentuximab vedotin can be intravenously administered every three weeks with each cycle of chemotherapy for up to 5 doses. In an aspect, a disclosed dose of brentuximab vedotin can comprise 1.8 mg / kg intravenously administered. In an aspect, a disclosed dose of brentuximab vedotin can comprise 1.8 mg / kg intravenously administered every three weeks. In an aspect, a disclosed dose of brentuximab vedotin can comprise 1.8 mg / kg intravenously administered every three weeks for up to 16 cycles. In an aspect, a disclosed maximum dose of brentuximab vedotin can comprise up to 180 mg. In an aspect, brentuximab vedotin can be intravenously administered every three weeks with each cycle of chemotherapy for up to 6 to 8 doses. In an aspect, a disclosed method can comprise modifying the dose of brentuximab vedotin. In an aspect, modifying the dose of brentuximab vedotin can comprise accelerating and / or increasing the dose of brentuximab vedotin. In an aspect, modifying the dose of brentuximab vedotin can comprise decreasing and / or reducing the doseof brentuximab vedotin. In an aspect, modifying the dose of brentuximab vedotin can be based on the subject's tolerance of one or more prior doses. In an aspect, modifying the dose of brentuximab vedotin can be based on the subject's development of one or more adverse events (e.g., hepatic toxicity and / or physiologic and / or metabolic perturbations) following of one or more prior doses. In an aspect, brentuximab vedotin can be administered until disease progression or until the subject demonstrates unacceptable toxicity. In an aspect, a disclosed method can further comprise the administenng of brentuximab vedotin until disease progression or until the subject demonstrates unacceptable toxicity. In an aspect, a disclosed method can further comprise observing the subject for a period following one or more administering steps. In an aspect, a disclosed observation period after administering brentuximab vedotin can comprise at least 15 minutes, at least 30 minutes, at least 45 minutes, at least 60 minutes, at least 75 minutes, at least 90 minutes, or more than 90 minutes. In an aspect, a disclosed observation period can comprise about 30 minutes or about 90 minutes. In an aspect, a disclosed observation period can comprise 1 or more days, 2 or more days, 3 or more days. 4 or more days, 5 or more days, 6 or more days, 7 or more days, or more than 1 week, or more than 2 weeks, or more than 3 weeks, or more than 4 weeks, or 1 or more months.

[0259] BRIGATINIB. In an aspect, a disclosed targeted therapy can comprise brigatinib. As described herein, brigatinib can be known to the art. In an aspect of a disclosed method, administering brigatinib can comprise oral administration. In an aspect, oral administration can comprise a tablet taken with or without food. In an aspect, oral administration does not comprise crushing, cutting, or chewing the tablet. In an aspect, oral administration can comprise swallowing the tablet whole. In an aspect, brigatinib can be used alone (e.g., as a monotherapy). In an aspect, a disclosed dose of brigatinib can comprise about 80 mg to about 100 mg. In an aspect, a disclosed dose of brigatinib can comprise about 90 mg. In an aspect, a disclosed dose of brigatinib can comprise about 160 mg to about 200 mg. In an aspect, a disclosed dose of brigatinib can comprise about 180 mg. In an aspect, oral administration can comprise administering about 90 mg brigatinib once daily. In an aspect, oral administration can comprise administering about 90 mg brigatinib once daily for the first 7 days of administration, and then increased to about 180 mg once daily. In an aspect, a disclosed dose of brigatinib can be escalated after 7 days but does not exceed 180 mg brigatinib daily. In an aspect, a disclosed 90 mg dose of brigatinib can comprise one 90 mg tablet or 30 mg tablets. In an aspect, a disclosed 180 mg dose of brigatinib can comprise one 180 mg tablet, two 90 mg tablets, or six 30 mg tablets. In an aspect, a disclosed method can comprise modifying the dose of brigatinib. In an aspect, modifying the dose of brigatinib can comprise accelerating and / orincreasing the dose of brigatinib. In an aspect, modifying the dose of brigatinib can comprise decreasing and / or reducing the dose of brigatinib. In an aspect, modifying the dose of brigatinib can be based on the subject's tolerance of one or more prior doses. In an aspect, modifying the dose of brigatinib can be based on the subject's development of one or more adverse events (e.g., hepatic toxicity and / or physiologic and / or metabolic perturbations) following of one or more prior doses. In an aspect, a disclosed method can further comprise repeating the administering of brigatinib until disease progression or until the subject demonstrates unacceptable toxicity. In an aspect, a disclosed method can further comprise observing the subject for a period following one or more administering steps. In an aspect, a disclosed observation period after administering brigatinib can comprise at least 15 minutes, at least 30 minutes, at least 45 minutes, at least 60 minutes, at least 75 minutes, at least 90 minutes, or more than 90 minutes. In an aspect, a disclosed observation period can comprise about 30 minutes or about 90 minutes. In an aspect, a disclosed observation period can comprise 1 or more days, 2 or more days, 3 or more days, 4 or more days, 5 or more days, 6 or more days, 7 or more days, or more than 1 week, or more than 2 weeks, or more than 3 weeks, or more than 4 weeks, or 1 or more months.

[0260] CABOZANTINIB. In an aspect, a disclosed targeted therapy can comprise cabozantinib. As described herein, cabozantinib can be known to the art. In an aspect of a disclosed method, administering cabozantinib can comprise oral administration. In an aspect, oral administration can comprise a capsule taken with or without food. In an aspect, oral administration does not comprise crushing, cutting, or chewing the tablet. In an aspect, oral administration can comprise swallowing the tablet whole. In an aspect, cabozantinib can be used alone (e.g., as a monotherapy). In an aspect, the subject does not consume food for at least 2 hours prior to oral administration of cabozantinib. In an aspect, the subject does not consume food for at least 1 hour after oral administration of cabozantinib. In an aspect, a disclosed dose of cabozantinib can comprise about 120 mg to about 160 mg. In an aspect, a disclosed dose of cabozantinib can comprise about 140 mg. In an aspect, oral administration can comprise administering about 140 mg cabozantinib once daily. In an aspect, a disclosed dose of cabozantinib can comprise seven 20 mg capsules. In an aspect, a disclosed dose of cabozantinib can comprise one 80 mg capsule and three 20 mg capsules. In an aspect, a disclosed method can comprise modifying the dose of cabozantinib. In an aspect, modifying the dose of cabozantinib can comprise accelerating and / or increasing the dose of cabozantinib. In an aspect, modifying the dose of cabozantinib can comprise decreasing and / or reducing the dose of cabozantinib. In an aspect, modifying the dose of cabozantinib can be based on thesubject's tolerance of one or more prior doses. In an aspect, modifying the dose of cabozantinib can be based on the subject's development of one or more adverse events (e.g., hepatic toxicity and / or physiologic and / or metabolic perturbations) following of one or more prior doses. In an aspect, a disclosed method can further comprise repeating the administering of cabozantinib. In an aspect, a disclosed method can further comprise repeating the administering of cabozantinib until disease progression or until the subject demonstrates unacceptable toxicity. In an aspect, a disclosed method can further comprise observing the subject for a period following one or more administering steps. In an aspect, a disclosed observation period after administering cabozantinib can comprise at least 15 minutes, at least 30 minutes, at least 45 minutes, at least 60 minutes, at least 75 minutes, at least 90 minutes, or more than 90 minutes. In an aspect, a disclosed observation period can comprise about 30 minutes or about 90 minutes. In an aspect, a disclosed observation period can comprise 1 or more days, 2 or more days, 3 or more days, 4 or more days, 5 or more days, 6 or more days, 7 or more days, or more than 1 week, or more than 2 weeks, or more than 3 weeks, or more than 4 weeks, or 1 or more months.

[0261] CARFILZOMIB. In an aspect, a disclosed targeted therapy can comprise carfilzomib. As described herein, carfilzomib can be known to the art. In an aspect of a disclosed method, administering carfilzomib can comprise intravenous administration. In an aspect, a disclosed method can further comprise administering hydration prior to the administering each dose of carfilzomib. In an aspect, hydration can comprise oral fluids and / or intravenous fluids. In an aspect, oral fluids can comprise about 30 mL per kg at least 48 hours prior to the first dose of carfilzomib. In an aspect, intravenous fluids can comprise about 250 mL to about 500 mL prior to each dose of carfilzomib. In an aspect, a disclosed method can further comprise administering intravenous fluids following the administration of carfilzomib. In an aspect, carfilzomib can be used alone (e.g., as a monotherapy). In an aspect, a disclosed method can further comprise premedicating the subject with dexamethasone. In an aspect, a disclosed dose of dexamethasone can be about 8 mg. In an aspect, dexamethasone can be administered orally and / or intravenously at least 30 minutes but not more than 4 hours prior to intravenously administering carfilzomib. In an aspect, a disclosed initial dose of carfilzomib can be intravenously administered during about a 10-minute period, about a 15-minute period, about a 20-minute period, about a 25 -minute period, or about a 30-minute period. In an aspect, a disclosed dose of carfilzomib as a monotherapy can comprise about 15 mg / m2to about 30 mg / m2intravenously administered over about a 5-minute period about 15-minute period twice weekly. In an aspect, a disclosed dose of carfilzomib as a monotherapy can comprise about 20mg / m2to about 27 mg / m2intravenously administered over about a 10-minute period twice weekly. In an aspect, carfilzomib can be intravenously administered on days 1. 8, and 15 of each 28-day cycle. In an aspect, a disclosed dose of carfilzomib as a monotherapy can comprise intravenously administering about 20 mg / m2on day 1 of cycle 1. In an aspect, a disclosed dose of carfilzomib as a monotherapy can comprise intravenously administering about 70 mg / m2on day 8 cycle 1. In an aspect, a disclosed dose of carfilzomib as a monotherapy can comprise intravenously administering about 70 mg / m2on day 15 and day. In an aspect, a disclosed dose of carfilzomib as a monotherapy can comprise intravenously administering about 70 mg / m2on day 1 of cycle 2 and subsequent cycles. In an aspect, a disclosed dose of carfilzomib as a monotherapy can comprise intravenously administering about 70 mg / m2on day 8 of cycle 2 and subsequent cycles. In an aspect, a disclosed dose of carfilzomib as a monotherapy can comprise intravenously administering about 70 mg / m2on day 15 of cycle 2 and subsequent cycles. In an aspect, carfilzomib can be intravenously administered on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. In an aspect, a disclosed dose of carfilzomib as a monotherapy can comprise intravenously administering about 20 mg / m2on day 1 and day 2 of cycle 1. In an aspect, a disclosed dose of carfilzomib as a monotherapy can comprise intravenously administering about 56 mg / m2on day 8 and day 9 of cycle 1. In an aspect, a disclosed dose of carfilzomib as a monotherapy can comprise intravenously administering about 56 mg / m2on day 15 and day 16 of cycle 1. In an aspect, a disclosed dose of carfilzomib as a monotherapy can comprise intravenously administering about 56 mg / m2on day 1 and day 2 of cycle 2 and subsequent cycles. In an aspect, a disclosed dose of carfilzomib as a monotherapy can comprise intravenously administering about 56 mg / m2on day 8 and day 9 of cycle 2 and subsequent cycles. In an aspect, a disclosed dose of carfilzomib as a monotherapy can comprise intravenously administering about 56 mg / m2on day 15 and day 16 cycle 2 and subsequent cycles. In an aspect, a disclosed dose of carfilzomib as a monotherapy can comprise intravenously administering about 20 mg / m2on day 1 and day 2 of cycle 1. In an aspect, a disclosed dose of carfilzomib as a monotherapy can comprise intravenously administering about 27 mg / m2on days 8, 9, 15, and 16 of cycle 1. In an aspect, a disclosed dose of carfilzomib as a monotherapy can comprise intravenously administering about 27 mg / m2on days I. 2, 8. 9,15, and 16 of cycles 2 through 12. In an aspect, a disclosed dose of carfilzomib as a monotherapy can comprise intravenously administering about 27 mg / m2on days 1, 2, 15, and 16 of cycle 13 and subsequent cycles. In an aspect, a disclosed cycle can comprise 28 days. In an aspect, starting at cycle 13, carfilzomib can be intravenously administered on days 1, 2, 15, and 16 of each 28-day cycle. In an aspect, a disclosed dose of carfilzomib can beadministered in combination with dexamethasone. In an aspect, a disclosed dose of carfilzomib can be administered in combination with daratumumab plus dexamethasone. In an aspect, a disclosed dose of carfilzomib can be administered in combination with daratumumab and hyaluronidase-fihj plus dexamethasone. In an aspect, a disclosed dose of carfilzomib can be administered in combination with isatuximab plus dexamethasone. In an aspect, daratumumab can be intravenously administered or subcutaneously administered. In an aspect, a disclosed dose of carfilzomib as a monotherapy can comprise about 15 mg / m2to about 30 mg / m2intravenously administered over about a 5-minute period about 15-minute period twice weekly. In an aspect, a disclosed dose of carfilzomib as a monotherapy can comprise about 20 mg / m2to about 27 mg / m2intr...

Claims

VI. CLAIMSWhat is claimed is:

1. A method for treating lung cancer, the method comprising: administering to a subject in need thereof a treatment regimen comprising a therapeutically effective amount of one or more antineoplastons or a pharmaceutical formulation thereof, and a therapeutically effective amount of one or more targeted therapies, wherein the subject demonstrates a tumor response and / or molecular response.

2. A method for treating lung cancer, the method comprising: administering to a subject in need thereof a treatment regimen comprising precision cancer treatment comprising a therapeutically effective amount of one or more antineoplastons, and a therapeutically effective amount of one or more targeted therapies, wherein the subject demonstrates a tumor response and / or molecular response to the treatment regimen.

3. The method of Claim 1 or Claim 2, wherein the one or more antineoplastons comprise phenylacetate, phenylacetylglutaminate sodium, phenylacetylisoglutaminate sodium, or a combination thereof.

4. The method of Claim 3, wherein the one or more antineoplastons comprise about a 4: 1 ratio of phenylacetylglutaminate sodium (PG) and phenylacetylisoglutaminate sodium (iso- PG).

5. The method of Claim 4, wherein the dose of phenylacetylglutaminate sodium (PG) comprises about 0.4 g / kg / day to about 20 g / kg / day, and wherein the dose of phenylacetylisoglutaminate sodium (iso-PG) comprises about 0. 1 g / kg / day to about 5 g / kg / day.

6. The method of Claim 3, wherein the one or more antineoplastons comprise about a 4: 1 ratio of phenylacetate (PN) and phenylacetylglutaminate sodium (PG).

7. The method of Claim 6, wherein the dose of phenylacetate (PN) comprises about 0.064 g / kg / day to about 0.48 g / kg / day, and wherein the dose of phenylacetylglutaminate sodium (PG) comprises about 0.016 g / kg / day to about 0.12 g / kg / day.

8. The method of Claim 1 or Claim 2, further comprising obtaining a biological sample from the subject prior to and / or after administering the treatment regimen.

9. The method of Claim 8, further comprising subjecting the biological sample to a cell-freeDNA (cfDNA) analysis.

10. The method of Claim 9, wherein the cfDNA analysis comprises next generation sequencing.

11. The method of Claim 10, wherein next generation sequencing comprises sequencing one or more cancer related genes.

12. The method of Claim 11, wherein sequencing one or more cancer related genes comprises identifying one or more genomic aberrations.

13. The method of Claim 12, wherein the one or more genomic aberrations comprise somatic genomic aberrations, and wherein the one or more somatic genomic aberrations comprise mutations, insertions, deletions, chromosomal rearrangements, copy number aberrations, or any combination thereof.

14. The method of Claim 12. wherein if the expression and / or amount of the one or more genomic aberrations in the pre-treatment biological sample is higher than the expression and / or amount of the same one or more genomic aberrations in a control sample, then diagnosing the subject as being in need of treatment regimen.

15. The method of Claim 11, wherein the cancer related gene comprises ALK, EGFR, EML4-ALK, EWSR1-FLI1, FBXW7, KRAS, NF1, RET, SMAD4, STK11, TERT, TP53, or any combination thereof.

16. The method of Claim 12, wherein if the expression and / or amount of the one or more genomic aberrations in the post-treatment biological sample is lower than the expression and / or amount of the same one or more genomic aberrations in a pretreatment sample, then continuing to administer to the subject the treatment regimen.

17. The method of Claim 12, wherein if the expression and / or amount of the one or more genomic aberrations in the post-treatment biological sample is lower than the expression and / or amount of the same one or more genomic aberrations in a prior posttreatment sample, then continuing to administer to the subject the treatment regimen.

18. The method of Claim 1 or Claim 2, further comprising measuring the subject's tumor response to the treatment regimen.

19. The method of Claim 1 or Claim 2, further comprising measuring the subject's molecular response to the treatment regimen.

20. The method of Claim 19, wherein the subject's molecular response comprises a decrease in the number of genomic aberrations in a post-treatment biological sample obtained from the subject.

21. The method of any preceding claim, further comprising administering to the subject one or more additional therapeutic agents, and wherein the one or more additional therapeuticagents comprise chemotherapeutic agents, monoclonal antibodies, small molecules, or any combination thereof.

22. The method of Claim 1 or Claim 2, wherein the one or more targeted therapies are orally administered and comprise abemaciclib, afatinib, alectinib, alpelisib, axitinib, binimetinib, bosutinib, brigatinib, cabozantinib, cobimetinib, crizotinib, dabrafenib, dacomitinib, dasatinib, duvelisib, encorafenib, entrectinib, erdafitinib, erlotinib, gefitinib. gilteritinib. ibrutinib, imatinib mesylate, ivosidenib, lapatinib, larotrectinib. lorlatinib, lenvatinb, neratinib, nilotinib, niraparib, olaparib, osimertinib palbociclib, pazopanib, ponatinib, pralsetinib, regorafenib, ribociclib, rucaparib, sorafenib, sunitinib malate, talazoparib, tivozanib, trametinib, vandetanib, vemurafenib, vismodegib, or any combination thereof.

23. The method of Claim 1 or Claim 2, wherein the one or more targeted therapies are intravenously administered and comprise ado-trastuzumab emtansine, alemtuzumab, atezolizumab, avelumab, bevacizumab, blinatumomab, brentuximab vedotin, carfilzomib, cetuximab, cemiplimab-rwlc, certinib, copanlisib. daratumumab, dinutuximab. durvalumab, elotuzumab, fam-trastuzumab deruxtecan-nxki. gemtuzumab ozogamicin, ibritumomab tiuxetan, inotuzumab ozogamicin, ipilimumab, margetuximab-cmkb, necitumumab, nivolumab, obinutuzumab, olaratumab, panitumumab, pembrolizumab, pertuzumab, ramucirumab, rituximab, tositumomab and iodine 1131 tositumomab, trastuzumab, ublituximab-xiiy, or any combination thereof.

24. The method of Claim 1 or Claim 2, wherein the one or more targeted therapies are subcutaneously administered and comprise denosumab, ofatumumab, or any combination thereof.

25. The method of any preceding claim, further comprising repeating one or more steps of the method, and wherein repeating one or more steps of the method comprises repeating the administering to the subj ect the precision cancer treatment, repeating the administering to the subject the treatment regimen, repeating the administering to the subject of one or more ANPs. repeating the administering to the subject of one or more targeted therapies, repeating the measuring of the subject's tumor response, repeating the obtaining of a biological sample from the subject, repeating the subjecting the biological sample to cfDNA analysis. repeating the administering of one or more additional therapeutic agents, orany combination thereof.

26. The method of any preceding claim, wherein prior to the administering of the treatment regimen, the subject has received surgical treatment, antibody treatment, chemotherapy treatment, radiation treatment, immunotherapy treatment, or any combination thereof.

27. The method of any preceding claim, wherein the cancer comprises lung cancer and / or metastatic lung cancer and / or terminal lung cancer.

28. The method of any preceding claim, further comprising monitoring the subject for adverse effects; and wherein in the absence of adverse effects, the method further comprises continuing to administering to the subject the treatment regimen, or wherein in the presence of adverse effects, the method further comprises modifying one or more steps of the method.

29. The method of Claim 28, further comprising treating the one or more adverse effects.

30. The method of any preceding claim, wherein treating the cancer comprises prolonging the subject's survivability, increasing the length of time before metastasis, reducing the risk of metastases, reducing the likelihood of surgical intervention, reducing the need for administration of one or more additional therapeutic agents or regiments, reducing the size of one or more tumors in the subject, eliminating one or more tumors in the subject, reducing or eliminating the prevalence of one or more genomic aberrations, restoring the normal metabolism of one or more organ systems in the subject, restoring one or more aspect of cellular homeostasis and / or cellular functionality and / or metabolic dysregulation, reducing and / or inhibiting aberrant angiogenesis and / or vasculogenesis in one or more tissues and / or organs of the subject, or any combination thereof.

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