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

NCT03574649 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: QUILT-2.024
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Relapse-free survival ( RFS)

  time from the date of randomization to the date of first radiographically determined new lesion by RECIST Version 1.1 based on BICR or date of death (by any cause), whichever occurs first

  18 months

Study Arms (2)

NANT NSCLC Combination Immunotherapy regimen

EXPERIMENTAL

Drug: Nab-paclitaxel; Drug: Cisplatin; Drug: 5Fluorouracil; Drug: Cyclophosphamide; Biological: ETBX-011; Biological: ETBX-051; Biological: ETBX-061; Biological: GI-4000; Biological: GI-6301; Drug: Aldoxorubicin; Drug: Avelumab; Drug: ALT-803; Biological: haNK

Standard of Care

ACTIVE COMPARATOR

Drug: Nab-paclitaxel; Drug: Cisplatin; Drug: Docetaxel; Drug: carboplatin

Interventions

Nab-paclitaxel DRUG

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

NANT NSCLC Combination Immunotherapy regimen; Standard of Care

Cisplatin DRUG

(SP-4-2)-diamminedichloroplatinum(II)

NANT NSCLC Combination Immunotherapy regimen; Standard of Care

5Fluorouracil DRUG

5-fluoro-2,4 (1H,3H)-pyrimidinedione

NANT NSCLC Combination Immunotherapy regimen

Cyclophosphamide DRUG

2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate

NANT NSCLC Combination Immunotherapy regimen

ETBX-011 BIOLOGICAL

adenovirus serotype-5 \[Ad5\] \[E1-, E2b-\]-carcinoembryonic antigen \[CEA\] vaccine

NANT NSCLC Combination Immunotherapy regimen

ETBX-051 BIOLOGICAL

Ad5 \[E1-, E2b-\]-Brachyury vaccine

NANT NSCLC Combination Immunotherapy regimen

ETBX-061 BIOLOGICAL

Ad5 \[E1-, E2b-\]-mucin 1 \[MUC1\] vaccine

NANT NSCLC Combination Immunotherapy regimen

GI-4000 BIOLOGICAL

RAS yeast vaccine

NANT NSCLC Combination Immunotherapy regimen

GI-6301 BIOLOGICAL

Brachyury yeast vaccine

NANT NSCLC Combination Immunotherapy regimen

Aldoxorubicin DRUG

INNO-206

NANT NSCLC Combination Immunotherapy regimen

Avelumab DRUG

Fully human anti-PD-L1 IgG1 lambda monoclonal antibody

NANT NSCLC Combination Immunotherapy regimen

ALT-803 DRUG

recombinant human super agonist interleukin-15 (IL-15) complex \[also known as IL-15N72D:IL-15RαSu/IgG1 Fc complex\]

NANT NSCLC Combination Immunotherapy regimen

haNK BIOLOGICAL

NK-92 \[CD16.158V, ER IL-2\], Suspension for Intravenous \[IV\] Infusion (haNK™ for Infusion)

NANT NSCLC Combination Immunotherapy regimen

Docetaxel DRUG

Docetaxel

Standard of Care

carboplatin DRUG

carboplatin

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Able to understand and provide a signed informed consent that fulfills the relevant IRB or IEC guidelines.
• Histologically-confirmed stage II-IIIa NSCLC.
• ECOG performance status of 0 to 2.
• Have at least 1 measurable lesion of \> 1.0 cm.
• Must have a recent FFPE tumor biopsy specimen following the conclusion of the most recent anticancer treatment and be willing to release the specimen for prospective and exploratory tumor molecular profiling. If an historic specimen is not available, the subject must be willing to undergo a biopsy during the screening period, if considered safe by the Investigator. If safety concerns preclude collection of a biopsy during the screening period, a tumor biopsy specimen collected prior to the conclusion of the most recent anticancer treatment may be used.
• Must be willing to provide blood samples prior to the start of treatment on this study for prospective tumor molecular profiling and exploratory analyses.
• Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
• Agreement to practice effective contraception for female subjects of child-bearing potential and non-sterile males. Female subjects of child-bearing potential must agree to use effective contraception for up to 1 year after completion of therapy, and non-sterile male subjects must agree to use a condom for up to 4 months after treatment. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), and abstinence.

You may not qualify if:

• Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the subject at high risk for treatment-related complications.
• Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, or autoimmune disease associated with lymphoma).
• History of organ transplant requiring immunosuppression.
• History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
• Inadequate organ function, evidenced by the following laboratory results:
• Absolute neutrophil count \< 1,000 cells/mm3.
• Uncorrectable grade 3 anemia (hemoglobin \< 8 g/dL).
• Platelet count \< 75,000 cells/mm3.
• Total bilirubin greater than the ULN; unless the subject has documented Gilbert's syndrome).
• AST (SGOT) or ALT (SGPT) \> 2.5 × ULN (\> 5 × ULN in subjects with liver metastases).
• ALP levels \> 2.5 × ULN (\> 5 × ULN in subjects with liver metastases, or \>10 × ULN in subjects with bone metastases).
• Serum creatinine \> 2.0 mg/dL or 177 μmol/L.
• Serum anion gap \> 16 mEq/L or arterial blood with pH \< 7.3.
• Uncontrolled hypertension (systolic \> 160 mm Hg and/or diastolic \> 110 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia requiring medication. Subjects with uncontrolled hypertension should be medically managed on a stable regimen to control hypertension prior to study entry.
• Serious myocardial dysfunction defined by ECHO as absolute LVEF 10% below the institution's lower limit of predicted normal.

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

Study Sites (1)

Chan Soon-Shiong Institute for Medicine

El Segundo, California, 90245, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

130-nm albumin-bound paclitaxel; Cisplatin; Fluorouracil; Cyclophosphamide; DOXO-EMCH; avelumab; ALT-803; Docetaxel; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Coordination Complexes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: July 2, 2018
• Study Start: June 1, 2018
• Primary Completion: August 1, 2018
• Study Completion: August 22, 2018
• Last Updated: February 21, 2025

Record last verified: 2018-06

Locations

US (1)