NCT03574649

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: ImmunityBio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized phase 2 study to compare the efficacy of neoadjuvant, consolidation, and adjuvant immunotherapy (NANT NSCLC Combination Immunotherapy; experimental arm) to standard of care (surgery and adjuvant chemotherapy; control arm) in subjects with stage II-IIIa resectable NSCLC.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Nab-paclitaxel	5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine
DRUG	Cisplatin	(SP-4-2)-diamminedichloroplatinum(II)
DRUG	5Fluorouracil	5-fluoro-2,4 (1H,3H)-pyrimidinedione
DRUG	Cyclophosphamide	2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
BIOLOGICAL	ETBX-011	adenovirus serotype-5 \[Ad5\] \[E1-, E2b-\]-carcinoembryonic antigen \[CEA\] vaccine
BIOLOGICAL	ETBX-051	Ad5 \[E1-, E2b-\]-Brachyury vaccine
BIOLOGICAL	ETBX-061	Ad5 \[E1-, E2b-\]-mucin 1 \[MUC1\] vaccine
BIOLOGICAL	GI-4000	RAS yeast vaccine
BIOLOGICAL	GI-6301	Brachyury yeast vaccine
DRUG	Aldoxorubicin	INNO-206
DRUG	Avelumab	Fully human anti-PD-L1 IgG1 lambda monoclonal antibody
DRUG	ALT-803	recombinant human super agonist interleukin-15 (IL-15) complex \[also known as IL-15N72D:IL-15RαSu/IgG1 Fc complex\]
BIOLOGICAL	haNK	NK-92 \[CD16.158V, ER IL-2\], Suspension for Intravenous \[IV\] Infusion (haNK™ for Infusion)
DRUG	Docetaxel	Docetaxel
DRUG	carboplatin	carboplatin

Timeline

• Start date: 2018-06-01
• Primary completion: 2018-08-01
• Completion: 2018-08-22
• First posted: 2018-07-02
• Last updated: 2025-02-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study