Relatlimab + Nivolumab + Chemotherapy for Lung Cancer

Recruiting at318 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Bristol-Myers Squibb

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment combining two immunotherapy drugs (relatlimab and nivolumab) with standard chemotherapy. It targets patients with advanced or recurrent lung cancer. The goal is to see if this combination improves outcomes compared to using just one immunotherapy drug with chemotherapy. Nivolumab has shown improved survival in the treatment of advanced non-small-cell lung cancer (NSCLC) previously treated with chemotherapy.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for adults with Stage IV or recurrent non-small cell lung cancer (NSCLC) who haven't had systemic anti-cancer treatment for advanced disease. They should have a good performance status, meaning they're fairly active and can care for themselves. People with certain gene mutations treatable by targeted therapy, untreated brain metastases, another active cancer, or previous immunotherapy are excluded.

Inclusion Criteria

I am fully active or have some restrictions but can still care for myself.

I haven't received any systemic anti-cancer treatments for my advanced cancer.

My lung cancer is confirmed to be advanced or has come back and is either SQ or NSQ type.

Exclusion Criteria

My cancer has specific mutations (EGFR, ALK, ROS-1, BRAF V600E) treatable with targeted therapy.

I have previously been treated with specific immunotherapy drugs.

My cancer has spread to the lining of my brain and spinal cord.

Treatment Details

Interventions

• Carboplatin (Alkylating agents)
• Cisplatin (Alkylating agents)
• Nivolumab (Monoclonal Antibodies)
• Pemetrexed (Anti-metabolites)
• Relatlimab (Monoclonal Antibodies)

Trial Overview The study tests the effectiveness of Relatlimab combined with Nivolumab and chemotherapy versus just Nivolumab with chemotherapy in treating NSCLC. It aims to see if adding Relatlimab improves response rates compared to the current standard which includes Nivolumab.

Participant Groups

Group I: Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT) Experimental Treatment 6 Interventions

Group II: Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT)) Experimental Treatment 7 Interventions

Group III: Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT)) Experimental Treatment 7 Interventions

Group IV: Part 2: Arm D (Nivolumab + PDCT) Active Control 5 Interventions

Carboplatin is already approved in Canada for the following indications:

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania