NCT06561386

A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 Expression ≥ 1%

A Phase 3, Randomized, Open-label Study of Nivolumab + Relatlimab Fixed-dose Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy as First-line Treatment for Participants With Non-squamous (NSQ), Stage IV or Recurrent Non-small Cell Lung Cancer and With Tumor Cell PD-L1 Expression ≥ 1%

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy of Nivolumab and Relatlimab in combination with chemotherapy to Pembrolizumab with Chemotherapy in participants with stage IV or recurrent Non-squamous Non-small Cell Lung Cancer with PD-L1 expression ≥ 1%

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab	Specified dose on specified days
DRUG	Relatlimab	Specified dose on specified days
DRUG	Pembrolizumab	Specified dose on specified days
DRUG	Carboplatin	Specified dose on specified days
DRUG	Pemetrexed	Specified dose on specified days
DRUG	Cisplatin	Specified dose on specified days

Timeline

• Start date: 2024-10-07
• Primary completion: 2030-07-30
• Completion: 2032-08-04
• First posted: 2024-08-20
• Last updated: 2026-03-31

Locations

282 sites across 30 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Denmark, France, Germany, India, Ireland, Italy, Japan, Mexico, Netherlands, New Zealand, Poland, Portugal, Romania, Saudi Arabia, South Africa, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study