A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

Completed · Phase 2

Conditions studied: Non-small Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer, Metastatic Non-small Cell Lung Cancer

In brief

The purpose of this study is to assess the safety profile of relatlimab plus nivolumab in combination with platinum doublet chemotherapy (PDCT) and to determine if nivolumab plus relatlimab in combination with PDCT improves overall response rate (ORR) when compared to nivolumab plus PDCT in participants with previously untreated Stage IV or recurrent non-small cell lung cancer (NSCLC).

Key facts

Study ID

NCT04623775

Run by

Bristol-Myers Squibb

People needed

468

Starts

2021-02-17

Expected to finish

2026-05-06

Last updated by the study team

2026-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed metastatic non-small cell lung cancer (NSCLC) of squamous (SQ) or non-squamous (NSQ) histology with Stage IV A/B (as defined by the 8th International Association for the Study of Lung Cancer Classification) or recurrent disease following multi-modal therapy for locally advanced disease.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of less than or equal to 1 at screening and confirmed prior to randomization.
• Measurable disease by computed tomography (CT) or magnetic resonance resources (MRI) per response evaluation criteria in solid tumor version 1.1 (RECIST 1.1) criteria.
• No prior systemic anti-cancer treatment (including epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors) given as primary therapy for advanced or metastatic disease.

You may not qualify if…

• Participants with EGFR, ALK, ROS-1, or known B-rapidly accelerated fibrosarcoma proto-oncogene (BRAF V600E) mutations that are sensitive to available targeted therapy.
• Untreated CNS metastases.
• Leptomeningeal metastases (carcinomatous meningitis).
• Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to randomization (ie, participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before randomization and the participant has no evidence of disease).
• Prior treatment with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), anti-programmed death-ligand 2 (PD-L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Where it is running

• Local Institution - 0081 — Orange, California, United States
• Local Institution - 0139 — New Haven, Connecticut, United States
• Local Institution - 0153 — Jacksonville, Florida, United States
• Local Institution - 0011 — Port Saint Lucie, Florida, United States
• Local Institution - 0089 — Athens, Georgia, United States
• Local Institution - 0121 — Wichita, Kansas, United States
• Local Institution - 0159 — Lexington, Kentucky, United States
• Local Institution - 0002 — Louisville, Kentucky, United States
• Local Institution - 0082 — Scarborough, Maine, United States
• Local Institution - 0129 — Omaha, Nebraska, United States
• Local Institution - 0152 — Howell Township, New Jersey, United States
• Local Institution - 0124 — Johnson City, New York, United States
• Local Institution - 0162 — Mineola, New York, United States
• Local Institution - 0128 — New York, New York, United States
• Local Institution - 0165 — New York, New York, United States
• Local Institution - 0097 — The Bronx, New York, United States
• Local Institution - 0117 — Durham, North Carolina, United States
• Local Institution - 0156 — Cincinnati, Ohio, United States
• Local Institution - 0155 — Cleveland, Ohio, United States
• Local Institution - 0084 — Lancaster, Pennsylvania, United States
• Local Institution - 0147 — Pittsburgh, Pennsylvania, United States
• Local Institution - 0148 — Providence, Rhode Island, United States
• Local Institution - 0083 — Greenville, South Carolina, United States
• Local Institution - 0149 — Dallas, Texas, United States
• Local Institution - 0160 — Duarte, California, United States

Full record on ClinicalTrials.gov

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