Study Comparing Nivolumab and Relatlimab with Chemotherapy to Pembrolizumab with Chemotherapy for Advanced Non-squamous Non-small Cell Lung Cancer

Sponsor: Bristol-Myers Squibb

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06561386

Provider View

This clinical trial is testing two different combinations of immunotherapy and chemotherapy to see which is more effective for treating patients with advanced or returning non-squamous non-small cell lung cancer that has a specific PD-L1 level.

Patient Parameters

Program Overview

The goal of this study is to find out which treatment works better for patients with stage IV or recurrent non-squamous non-small cell lung cancer. Researchers are comparing two combinations: one uses the drugs Nivolumab and Relatlimab with chemotherapy, and the other uses Pembrolizumab with chemotherapy. The study focuses on patients whose cancer cells have a PD-L1 level between 1% and 49%.

Eligibility Criteria

Inclusion Criteria

  • Participants must have histologically confirmed Stage IV or recurrent Non-small Cell Lung Cancer (NSCLC) of non-squamous (NSQ) histology with no prior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease.
  • Participants must have measurable PD-L1 ≥ 1% Tumor Cell (TC) score by the investigational PD-L1 immunohistochemistry (IHC) assay VENTANA PD-L1 (SP263) CDx Assay conducted by central laboratory during the screening period prior to randomization.
  • Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria.
  • Participants must have an Easter Cooperative Oncology Group (ECOG) performance status of ≤ 1 at screening.
  • Participants must have a life expectancy of at least 3 months at the time of randomization.

Exclusion Criteria

  • Participants must not be pregnant and/or breastfeeding.
  • Participants with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS-1 mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown EGFR, ALK, or ROS-1 status are excluded.
  • Participants with known BRAFV600E mutations, that are sensitive to available targeted inhibitor therapy; participants with known activating rearranged during transfection (RET) mutations or neurotrophic tyrosine receptor kinase (NTRK) fusion gene alterations are excluded. Participants with unknown or indeterminate BRAF mutation, activating RET mutations or NTRK fusion gene alterations are eligible.
  • Participants must not have untreated central nervous system (CNS) metastases.
  • Participants must not have leptomeningeal metastases (carcinomatous meningitis).
  • Participants must not have concurrent malignancy requiring treatment.
  • Participants must not have an active autoimmune disease.
  • Participants must not have history of interstitial lung disease or pneumonitis that required oral or intravenous (IV) glucocorticoids to assist with management.
  • Participants must not have a history of myocarditis.
  • Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or other antibody or drug targeting T-cell co-stimulation or checkpoint pathways.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

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