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%

Phase 3

Recruiting

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Pembrolizumab; Drug: Nivolumab; Drug: Relatlimab; Drug: Carboplatin; Drug: Pemetrexed; Drug: Cisplatin

• Registration Number: NCT06561386
• Lead Sponsor: Bristol-Myers Squibb

Brief 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%

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-16
• Study First Submitted QC: 2024-08-16
• Study First Posted: 2024-08-20
• Study Start: 2024-10-07
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-15
• Primary Completion: 2030-07-30
• Study Completion: 2033-11-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B	Pembrolizumab	-
Arm A	Pemetrexed	-
Arm A	Nivolumab	-
Arm A	Carboplatin	-
Arm B	Pemetrexed	-
Arm A	Cisplatin	-
Arm B	Carboplatin	-
Arm B	Cisplatin	-
Arm A	Relatlimab	-

Primary Outcome Measures

Name	Time	Method
Overall survival (OS) in randomized participants with PD-L1 1% to 49%	Up to 5 years

Secondary Outcome Measures

Name	Time	Method
Duration of response (DoR)	Up to 5 years
Number of participants with adverse events (AEs)	Up to 2.5 years
Number of participants with serious adverse events (SAEs)	Up to 2.5 years
OS in randomized participants with PD-L1 ≥ 1%	Up to 5 years
Progression-free survival (PFS) as assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR)	Up to 5 years
Overall response rate (ORR)	Up to 5 years
Number of participants with immune-mediated adverse events (IMAEs)	Up to 2.5 years
The time until definitive deterioration based on non-small cell lung cancer - symptom assessment questionnaire (NSCLC-SAQ) total score	Up to 2 years

Trial Locations

Locations (272)

Southern Arizona VA Health Care System; 🇺🇸 Tucson, Arizona, United States

Local Institution - 0112; 🇺🇸 Los Angeles, California, United States

University of California Davis (UC Davis) Comprehensive Cancer Center; 🇺🇸 Sacramento, California, United States

San Francisco Oncology Associates; 🇺🇸 San Francisco, California, United States

UCLA Hematology/Oncology - Santa Monica; 🇺🇸 Santa Monica, California, United States

University of Miami Hospital and Clinics, Sylvester Cancer Center; 🇺🇸 Miami, Florida, United States

Memorial Hospital West; 🇺🇸 Pembroke Pines, Florida, United States

Florida Cancer Specialists - North; 🇺🇸 Saint Petersburg, Florida, United States

Florida Cancer Specialists - East; 🇺🇸 West Palm Beach, Florida, United States

Affiliated Oncologists, LLC; 🇺🇸 Chicago Ridge, Illinois, United States

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