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: 2025-10
• Last Update Submitted: 2025-10-10
• Last Update Posted: 2025-10-14
• Primary Completion: 2030-07-30
• Study Completion: 2032-08-04

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 (276)

The First affiliated hospital of Nanchang University (Xianghu campus); 🇨🇳 Nanchang, Jiangxi, China

Shanxi Cancer Hospital; 🇨🇳 Taiyuan, Shanxi, China

CHU Lille - Institut Coeur Poumon; 🇫🇷 Lille, Nord, France

Klinikum Esslingen; 🇩🇪 Esslingen am Neckar, Baden-Wurttemberg, Germany

Klinikum der Ludwig-Maximilians-Universitaet Muenchen; 🇩🇪 München, Bavaria, Germany

Klinikum Chemnitz; 🇩🇪 Chemnitz, Saxony, Germany

LungenClinic Grosshansdorf; 🇩🇪 Großhansdorf, Schleswig-Holstein, Germany

Charité Campus Virchow-Klinikum; 🇩🇪 Berlin, Germany

Universitätsklinikum Bonn; 🇩🇪 Bonn, Germany

Universitaetsklinikum Essen; 🇩🇪 Essen, Germany

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