QUILT -2.023: A phase 2, open-label, randomized study of ALT-803 in combination with pembrolizumab vs pembrolizumab alone as first-line treatment for patients with metastatic NSCLC

Updated on 31 March 2021


This is a phase 2, open-label, randomized study to compare the safety and efficacy of combination therapy with ALT-803 and pembrolizumab (experimental arm) versus pembrolizumab alone (control arm), as first-line treatment for subjects with metastatic NSCLC in which pembrolizumab is indicated for first-line treatment.


The primary objective is to compare the efficacy of treatment with N-803 in combination with pembrolizumab vs pembrolizumab monotherapy as assessed by progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on Blinded Independent Central Review (BICR). 

Secondary objectives are to compare key secondary measures of efficacy (by overall survival [OS] and overall response rate [ORR] using RECIST 1.1 based on BICR) and safety.

Condition Non-Small Cell Lung Cancer
Clinical Study IdentifierTX270118
Last Modified on31 March 2021


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Inclusion Criteria

Age ≥ 18 years old
Able to understand and provide a signed informed consent that fulfills the relevant IRB or Independent Ethics Committee (IEC) guidelines
Histologically-confirmed stage 3 or 4 NSCLC disease. Subjects with stage 3 disease must not be candidates for treatment with surgical resection or chemoradiation
Subjects must not have received prior systemic chemotherapy for advanced or metastatic NSCLC. Previous neoadjuvant/adjuvant chemotherapy is allowed if completed ≥ 6 months before diagnosis of metastatic disease. Subject's with newly-diagnosed stage 4 NSCLC may have previously received systemic chemotherapy for stage 3 NSCLC
For Cohort A only: NSCLC tumors must have PD-L1 expression (i.e. a TPS ≥1%) as determined by an FDA-approved test
The subject's tumor must not harbor an EGFR sensitizing (activating) mutation or ALK translocation or targetable genomic aberration in BRAF, ROS1 or NTRK. EGFR sensitizing mutations are those mutations that are amenable to treatment with tyrosine kinase inhibitors including erlotinib, gefitinib, or afatinib. Investigators must be able to produce the source documentation of the EGFR mutation, ALK translocation, and BRAF, ROS1, and NTRK status. If any of the genomic changes described above are detected, additional information regarding the mutation status of other molecules is not required. If unable to test for these molecular changes, formalin fixed paraffin embedded tumor tissue of any age should be submitted to a central laboratory designated by the Sponsor for such testing. Subjects will not be randomized until the EGFR , BRAFT, ROS1, and NTRK mutation status and ALK translocation status is available in source documentation at the site
ECOG performance status of 0 or 1
Measurable tumor lesions according to RECIST 1.1
Must be willing to release tumor biopsy specimen used for diagnosis of advanced or metastatic NSCLC (if available) for exploratory tumor molecular profiling. If tumor biopsy specimen is not available, subjects can still be enrolled
Must be willing to provide blood samples prior to the start of treatment on this study for exploratory tumor molecular profiling analysis
Must be willing to provide a tumor biopsy specimen 9 weeks after the start of treatment for exploratory analyses, if considered safe by the Investigator
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), hormonal therapy, and abstinence

Exclusion Criteria

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
A history of prior malignancy with the following exceptions: cancer treated with curative therapy with no disease recurrence for >3 years, non-metastatic prostate cancer controlled with hormonal therapy, or under observation; non-metastatic thyroid cancer; basal or squamous cell carcinoma of the skin, superficial bladder cancer, or in situ cervical cancer that has undergone successful definitive resection
Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, or autoimmune disease associated with lymphoma)
History of organ transplant requiring immunosuppression; or history of pneumonitis or interstitial lung disease requiring treatment with systemic steroids; or a history of receiving systemic steroid therapy or any other immunosuppressive medication ≤ 3 days prior to study initiation. Daily steroid replacement therapy (eg, prednisone or hydrocortisone) and corticosteroid use to manage AEs are permitted
Prior systemic chemotherapy, major surgery, or thoracic radiation within 3 weeks of study initiation
Requirement for other forms of anticancer treatment while on trial, including maintenance therapy, other radiation therapy, and/or surgery. Palliative radiation is permitted
Known CNS metastases or carcinomatous meningitis. Subjects with previously treated, stable CNS metastases (no evidence of progression for ≥ 4 weeks, and resolution of neurologic symptoms to baseline state) are permitted in this study
History of receiving a live vaccine 30 days prior to study treatment
History of human immunodeficiency virus (HIV), or known active hepatitis B or C infection
An active infection requiring systemic IV therapy
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 < 1,500 cells/mm3
Platelet count < 100,000 cells/mm3
Total bilirubin greater the upper limit of normal (ULN; unless the subject has documented Gilbert's syndrome)
Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase (ALT [SGPT]) > 1.5 × ULN
Alkaline phosphatase (ALP) levels > 2.5 × ULN
Serum creatinine > 2.0 mg/dL or 177 μmol/L or creatinine clearance < 40 mL/min (using the Cockcroft-Gault formula)
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
Dyspnea at rest due to complications of advanced malignancy or other disease requiring continuous oxygen therapy
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
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
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