Therapy Detail

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Therapy Name	Aldoxorubicin + Avelumab + Cisplatin + Cyclophosphamide + ETBX-011 + ETBX-051 + ETBX-061 + Fluorouracil + GI-4000 + GI-6301 + haNK cells + Nogapendekin alfa inbakicept + Paclitaxel
Synonyms	NANT non-small cell lung cancer vaccine combination
Therapy Description

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Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description
Aldoxorubicin		INNO-206\|Doxorubicin-EMCH	Chemotherapy - Anthracycline 13	Aldoxorubicin (Doxorubicin-EMCH) is a derivative prodrug of doxorubicin that is converted to free doxorubicin within the acidic environment within tumors, and once converted, doxorubicin intercalates DNA, inhibits DNA synthesis and induces apoptosis (PMID: 30936721).
Avelumab	Bavencio	MSB0010718C	Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 124	Bavencio (avelumab) is a monoclonal antibody binds to human immunosuppressive ligand programmed death-ligand 1 (PD-L1, CD274) and blocks protein signaling, resulting in immune regulation and antitumor immunity (PMID: 26014098). Bavencio (avelumab) is FDA-approved for use in adult and pediatric patients of 12 years or older with metastatic Merkel cell carcinoma, as maintenance therapy in locally advanced or metastatic urothelial carcinoma (UC), in locally advanced or metastatic UC that progressed following chemotherapy, and in combination with axitinib as first-line therapy in advanced renal cell carcinoma (FDA.gov).
Cisplatin	Platinol	CDDP	Chemotherapy - Platinum 7	Platinol (cisplatin) is a platinum based chemotherapeutic, which is FDA approved for bladder, ovarian, and testicular cancers (NCI Drug Dictionary).
Cyclophosphamide	Cytoxan	CPM	Chemotherapy - Alkylating 18	Cytoxan (cyclophosphamide) is an alkylating agent, which inhibits DNA replication (NCI Drug Dictionary). Cytoxan (cyclophosphamide) is FDA approved in multiple hematological malignancies, breast cancer, neuroblastoma, ovarian cancer, and retinoblastoma (NCI Drug Dictionary).
ETBX-011		ETBX 011\|ETBX011		ETBX-011 is an engineered adenoviral vaccine encoding human carcinoembryonic antigen that may stimulate anti-tumor immunity (Journal of Clinical Oncology 32, no. 15_suppl (May 2014) 3093-3093, PMID: 31594913).
ETBX-051		ETBX051\|ETBX 051		ETBX-051 is a virally based vaccine that infects cells and induces expression of the brachyury protein protein, which may activate the immune system to elicit a cytotoxic T-lymphocyte (CTL) response against brachyury expressing tumor cells (PMID: 31594913).
ETBX-061		ETBX061\|ETBX 061		ETBX-061 is a virally based vaccine that infects cells and causes expression of the Muc1 protein, which may activate the immune system to elicit a cytotoxic T-lymphocyte (CTL) response against Muc1 expressing tumor cells (PMID: 31594913).
Fluorouracil	Adrucil	5-FU\|5-Fluorouracil	Chemotherapy - Antimetabolite 14	Adrucil (fluorouracil) is an antimetabolite chemotherapeutic agent, which interferes with DNA and RNA synthesis thereby preventing cancer cell growth and is FDA approved for colorectal, breast, stomach, and pancreatic cancer (FDA.gov).
GI-4000		GI 4000\|GI4000	RAS Inhibitor (Pan) 12	GI-4000 vaccine elicits an immune response by stimulating a specific cytotoxic T-cell response against the mutated forms of Ras (PMID: 29528991).
GI-6301				GI-6301 is a cancer vaccine that activates immune response against tumor cells (PMID: 26130065).
haNK cells		CD16.158V ER IL-2\|NK-92 cells		haNK cells are natural killer cells, specifically from the NK-92 cell line, that have been engineered to express IL-2 and the CD16 allele, and when combined with other therapies such as an immunotherapy can synergistically enhance antibody-dependent cell-mediated cytotoxicity (PMID: 28477372).
Nogapendekin alfa inbakicept	Anktiva	N-803\|N803\|N 803\|nogapendekin alfa\|ALT803\|ALT 803\|ALT-803		Anktiva (nogapendekin alfa inbakicept) is a fusion protein comprising a mutant version of IL-15 with increased activity and IL-15Ra fused to the Fc region of IgG1, which activates CD8+ T-cells and promotes effector activity, potentially resulting in increased antitumor immune response (PMID: 24404427, PMID: 31338557). Anktiva (nogapendekin alfa inbakicept) in combination with BCG is FDA approved for use in patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors (FDA.gov).
Paclitaxel	Taxol	7-Epipaclitaxel	Antimicrotubule Agent 14 BCL2 Family Inhibitor 6	Taxol (paclitaxel) binds to tubulin to inhibit microtubule disassembly, which results in decreased cell division, and also binds to the anti-apoptotic factor Bcl-2, promoting apoptosis (NCI Drug Dictionary).

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Clinical Trial	Phase	Therapies	Title	Recruitment Status	Covered Countries	Other Countries
NCT03574649	Phase II	Carboplatin + Cisplatin + Docetaxel + Paclitaxel Aldoxorubicin + Avelumab + Cisplatin + Cyclophosphamide + ETBX-011 + ETBX-051 + ETBX-061 + Fluorouracil + GI-4000 + GI-6301 + haNK cells + Nogapendekin alfa inbakicept + Paclitaxel	QUILT-2.024: Phase 2 Neoadjuvant, Consolidation, and Adjuvant Combination NANT Immunotherapy Versus Standard of Care in Subjects With Resectable Non-small Cell Lung Cancer	Withdrawn	USA	0

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