Comparing two treatments for advanced non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of Nivolumab and Relatlimab combined with chemotherapy against Pembrolizumab combined with chemotherapy in patients with stage IV or recurrent non-squamous non-small cell lung cancer that has a PD-L1 expression of 1% or higher. Participants will be randomly assigned to receive one of the two treatment regimens. The study will measure the efficacy based on tumor response and progression-free survival. It is a Phase 3 interventional trial, indicating a focus on confirming the effectiveness of these treatment combinations.

Why it matters

Who can join: the full rules

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.
* 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 T-cell co-stimulation or checkpoint pathways. Note: Anti-PD-1, anti-PD-L1 or anti-CTLA-4 therapy given in an adjuvant, neoadjuvant or perioperative setting with at least 6 months between the last dose and date of recurrence are allowed.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Where it's running

• Southern Arizona VA Health Care System
  Tucson, Arizona, United States Recruiting
• University of California Davis (UC Davis) Comprehensive Cancer Center
  Sacramento, California, United States Recruiting
• UCLA Hematology/Oncology - Santa Monica
  Santa Monica, California, United States Recruiting
• Florida Cancer Specialists - North
  St. Petersburg, Florida, United States Recruiting
• Florida Clinical Trials Group.
  Tamarac, Florida, United States Recruiting
• Florida Cancer Specialists - East
  West Palm Beach, Florida, United States Recruiting

+280 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.