Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Conditions
Interventions
Intervention1: Arm A:Nivolumab + Relatlimab Fixed Dose Combination With Chemotherapy: Arm A: Nivolumab + Relatlimab 360 mg/360 mg (FDC [1:1]) Q3W + 4 cycles of PDCT ( Platinum Doublet Chemotherapy) Q3
Sponsors
Bristol Myers Squibb India Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Main Inclusion Criteria -Males and females >= 18 years of age or local age of majority. -Histologically confirmed Stage IV or recurrent NSCLC(as defined by the 8th International Association for the Study of Lung Cancer Classification) of NSQ histology with no prior systemic anti-cancer therapy (including targeted treatment, for epidermal growth factor receptor [EGFR], anaplastic lymphoma kinase [ALK], ROS-1 and if previously identified, B-rapidly accelerated fibrosarcoma proto-oncogene [BRAF]-1 inhibitors, rearranged during transfection [RET] inhibitors and inhibitors of neurotrophic tyrosine receptor kinase [NTRK] gene fusions)given as primary therapy for advanced or metastatic disease. -PD-L1 tumor cell expression 1% to 49%. Participants must have PD-L1 immunohistochemistry (IHC) results from a central laboratory during the screening period prior to randomization. -Measurable disease by computed tomography or magnetic resonance imaging per Response Evaluation Criteria in Solid Tumors v1.1 criteria; radiographic tumor assessment performed within 28 days before randomization. -ECOG Performance Status of -Participants must have a life expectancy of at least 3 months at the time of randomization.
Exclusion criteria
Exclusion criteria: Main Exclusion Criteria -Women who are pregnant or breastfeeding. -Participants with EGFR, ALK, or ROS-1 mutations that are sensitive to available targeted inhibitor therapy. All participants must have been tested for EGFR, ALK, or ROS-1 mutation status. Participants with unknown EGFR, ALK, or ROS-1 status are excluded. -Participants with known BRAFV600Emutations, that are sensitive to available targeted inhibitor therapy; participants with known activating RET mutations and NTRK fusion gene alterations are excluded. Participants with unknown or indeterminate BRAF mutation, activating RET mutations or NTRK fusion gene alterations are eligible. -Participants with uncontrolled and untreated central nervous system metastases. -Participants with leptomeningeal metastases (carcinomatous meningitis). -Concurrent malignancy requiring treatment. -Participants with active autoimmune disease. -Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting the T-cell co-stimulation or checkpoint pathways. -Participants with history of myocarditis -Participants who have history of interstitial lung disease (ILD) or pneumonitis that required oral or intravenous (IV)glucocorticoids to assist with management.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare OS of Arm A with Arm B in participants with previously untreated Stage IV or recurrent NSQ NSCLC withPD-L1 1% to 49%.Timepoint: Overall survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare PFS of Arm A and Arm B per BICR in participants with previously untreated Stage IV or recurrent NSQ NSCLC withPD-L1 1% to49%.Timepoint: PFS by RECIST v1.1 per BICR;To evaluate ORR and DoR per BICR, of Arm A and Arm B in participants with previously untreated Stage IV or recurrent NSQ NSCLC withPD-L1 1% to49%.Timepoint: -ORR by RECIST v1.1 per BICR -DoR by RECIST v1.1 per BICR;To evaluate ORR, DoRnd PFS per investigator, of Arm A and Arm B in participants with previously untreated Stage IV or recurrent NSQNSCLC withPD-L1 1% to 49%.Timepoint: - ORR by RECIST 1.1 per Investigator - DoR by RECIST 1.1 per Investigator - PFS by RECIST 1.1 per Investigator;To evaluate the safety and tolerability of Arm A and Arm B in participants with previously untreated Stage IV or recurrent NSQ NSCLC withPD-L1 1% to 49%Timepoint: Incidence of AEs, SAEs, IMAEs and select AEs.;To evaluate TTD in disease-related symptoms of Arm A and Arm B in participants with previously untreated Stage IV or recurrent NSQ NSCLC withPD-L1 1% to49%.Timepoint: TTD based on NSCLC-SAQ total score. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Denmark, France, Germany, India, Italy, Japan, Netherlands, Poland, Republic of Korea, Romania, Spain, Switzerland, Taiwan, United Kingdom, United States of America
Contacts
Public ContactDr Kartik Doshi
Bristol Myers Squibb India Pvt. Ltd.
Outcome results
None listed