A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%. (ROSETTA Lung-202)
NCT07361510 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 750
Last updated 2026-05-13
Summary
The purpose of this study is to evaluate the efficacy of Pumitamig versus Pembrolizumab in participants with previously untreated advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%.
Conditions
- Non-Small Cell Lung Cancer (NSCLC)
Interventions
- DRUG
-
Pumitamig
Specified dose on specified days
- DRUG
-
Specified dose on specified days
Sponsors & Collaborators
- collaborator INDUSTRY
- lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-12
- Primary Completion
- 2031-10-14
- Completion
- 2031-10-14
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Austria
- Belgium
- Brazil
- Bulgaria
- Canada
- Chile
- China
- Colombia
- Czechia
- Finland
- France
- Germany
- Hungary
- India
- Italy
- Japan
- Malaysia
- Mexico
- Netherlands
- Norway
- Peru
- Poland
- Portugal
- Romania
- Singapore
- South Korea
- Spain
- Sweden
- Switzerland
- Taiwan
- Thailand
- Turkey (Türkiye)
- United Kingdom
Study Locations
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