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AzTrials

Non Small Cell Lung CancerPhase 2NCT03574649

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

A Phase 2 study testing Nab-paclitaxel, Cisplatin and 5Fluorouracil in people with Non Small Cell Lung Cancer, run by ImmunityBio, Inc. at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Nab-paclitaxel, Cisplatin and 5Fluorouracil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Jun 2018to 22 Aug 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Dyspnea at rest due to complications of advanced malignancy or other disease requiring continuous oxygen therapy.
  • Positive results of screening test for HIV.
  • Current chronic daily treatment (continuous for > 3 months) with systemic corticosteroids (dose equivalent to or greater than 10 mg/day methylprednisolone), excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in subjects who have known contrast allergies is allowed.
  • Known hypersensitivity to any component of the study medication(s).
  • Subjects taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.
  • Concurrent or prior use of a strong cytochrome P450 (CYP)3A4 inhibitor (including ketoconazole, itraconazole, posaconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, and grapefruit products) or strong CYP3A4 inducers (including phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, and St John's Wort) within 14 days before study day 1.
  • Concurrent or prior use of a strong CYP2C8 inhibitor (gemfibrozil) or moderate CYP2C8 inducer (rifampin) within 14 days before study day 1.
  • Participation in an investigational drug study or history of receiving any investigational treatment within 30 days prior to screening for this study, except for testosterone-lowering therapy in men with prostate cancer.
  • Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
  • Concurrent participation in any interventional clinical trial.
  • Pregnant and nursing women.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Chan Soon-Shiong Institute for Medicine

    El Segundo, California, 90245

Other trials in United States

About this study

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.

Being tested
Nab-paclitaxel, Cisplatin, 5Fluorouracil, Cyclophosphamide, ETBX-011
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nab-paclitaxelDrug

    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

  • CisplatinDrug

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

  • 5FluorouracilDrug

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

  • CyclophosphamideDrug

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

  • ETBX-011Biological

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

  • ETBX-051Biological

    Ad5 [E1-, E2b-]-Brachyury vaccine

  • ETBX-061Biological

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

  • GI-4000Biological

    RAS yeast vaccine

  • GI-6301Biological

    Brachyury yeast vaccine

  • AldoxorubicinDrug

    INNO-206

  • AvelumabDrug

    Fully human anti-PD-L1 IgG1 lambda monoclonal antibody

  • ALT-803Drug

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

  • haNKBiological

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

  • DocetaxelDrug

    Docetaxel

  • carboplatinDrug

    carboplatin

Study groups in NCT03574649
Study groupRoleWhat they receive
NANT NSCLC Combination Immunotherapy regimenExperimentalNot described
Receives: 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 CareActive comparatorNot described
Receives: Drug: Nab-paclitaxel; Drug: Cisplatin; Drug: Docetaxel; Drug: carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2018
  2. Study startJun 2018 (estimated)
  3. Primary completionAug 2018 (estimated)
  4. Study completion22 Aug 2018

Why it stopped: Trial not initiated

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03574649
Sponsor's protocol ID
QUILT-2.024
Status last verified
Jun 2018
First submitted
21 Jun 2018
Last updated
21 Feb 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nab-paclitaxel, Cisplatin and 5Fluorouracil in people with Non Small Cell Lung Cancer, run by ImmunityBio, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relapse-free survival ( RFS) (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03574649.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.

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