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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

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ClinicalTrials.gov Identifier: NCT03574649
Recruitment Status : Not yet recruiting
First Posted : July 2, 2018
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
NantKwest, Inc.

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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer 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 Drug: Docetaxel Drug: carboplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 558 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: NANT NSCLC Combination Immunotherapy regimen 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)

Active Comparator: Standard of Care 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: Docetaxel
Docetaxel

Drug: carboplatin
carboplatin




Primary Outcome Measures :
  1. Relapse-free survival ( RFS) [ Time Frame: 18 months ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Able to understand and provide a signed informed consent that fulfills the relevant IRB or IEC guidelines.
  3. Histologically-confirmed stage II-IIIa NSCLC.
  4. ECOG performance status of 0 to 2.
  5. Have at least 1 measurable lesion of > 1.0 cm.
  6. 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.
  7. Must be willing to provide blood samples prior to the start of treatment on this study for prospective tumor molecular profiling and exploratory analyses.
  8. Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
  9. 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.

Exclusion Criteria:

  1. 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.
  2. Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, or autoimmune disease associated with lymphoma).
  3. History of organ transplant requiring immunosuppression.
  4. History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
  5. Inadequate organ function, evidenced by the following laboratory results:

    1. Absolute neutrophil count < 1,000 cells/mm3.
    2. Uncorrectable grade 3 anemia (hemoglobin < 8 g/dL).
    3. Platelet count < 75,000 cells/mm3.
    4. Total bilirubin greater than the ULN; unless the subject has documented Gilbert's syndrome).
    5. AST (SGOT) or ALT (SGPT) > 2.5 × ULN (> 5 × ULN in subjects with liver metastases).
    6. ALP levels > 2.5 × ULN (> 5 × ULN in subjects with liver metastases, or >10 × ULN in subjects with bone metastases).
    7. Serum creatinine > 2.0 mg/dL or 177 μmol/L.
    8. Serum anion gap > 16 mEq/L or arterial blood with pH < 7.3.
  6. 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.
  7. Serious myocardial dysfunction defined by ECHO as absolute LVEF 10% below the institution's lower limit of predicted normal.
  8. Dyspnea at rest due to complications of advanced malignancy or other disease requiring continuous oxygen therapy.
  9. Positive results of screening test for HIV.
  10. 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.
  11. Known hypersensitivity to any component of the study medication(s).
  12. Subjects taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.
  13. 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.
  14. Concurrent or prior use of a strong CYP2C8 inhibitor (gemfibrozil) or moderate CYP2C8 inducer (rifampin) within 14 days before study day 1.
  15. 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.
  16. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
  17. Concurrent participation in any interventional clinical trial.
  18. Pregnant and nursing women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03574649


Locations
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United States, California
Chan Soon-Shiong Institute for Medicine
El Segundo, California, United States, 90245
Sponsors and Collaborators
NantKwest, Inc.

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Responsible Party: NantKwest, Inc.
ClinicalTrials.gov Identifier: NCT03574649     History of Changes
Other Study ID Numbers: QUILT-2.024
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Bronchial Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Cyclophosphamide
Fluorouracil
Carboplatin
Docetaxel
Albumin-Bound Paclitaxel
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antimetabolites
Antimetabolites, Antineoplastic