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

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

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

Sponsors & Collaborators

• ImmunityBio, Inc.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-06-30

Primary Completion

2018-08-31

Completion

2018-08-22

FDA Drug

Yes

Countries

• United States

Study Locations