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NCT06561386Phase 3RECRUITING

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%

Study 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 / Drugs
NivolumabRelatlimabPembrolizumabCarboplatinPemetrexedCisplatin
View on ClinicalTrials.gov ↗
Sponsor
BMY
Bristol-Myers Squibb
Oncology
F27/100
Study Details
Enrollment1000 participants
Primary Completion—
Lead SponsorBristol-Myers Squibb
Data Retrieved2026-04-11 04:08:14.746370+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.

Enrolled: 1,000 participants
Sponsor Catalyst Profile

Bristol-Myers Squibb (BMY) is the sponsoring company for this trial. BiotechSign currently grades this company F (27/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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