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Clinical Trials in the UK / NCT07361510
Recruiting Phase 3

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 · tracked via the Priya Life Science UK tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 3
Started
2026-03-12
Last updated
2026-09-08

Condition(s) studied

Non-Small Cell Lung Cancer (NSCLC)

Investigational drug(s) / intervention(s)

PumitamigPembrolizumab

Pumitamig: Specified dose on specified days

Pembrolizumab: Specified dose on specified days

Study 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%.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria * Participants must have a histologically or cytologically confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC) (squamous and nonsquamous) with Stage IIIB/IIIC or Stage IV disease. * Participants must have a programmed death ligand-1 (PD-L1) expression ≥ 50%. * Participants must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * Participants must have no prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC. * Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. Exclusion Criteria * Participants must not have any documented actionable genomic alteration (AGA) for which first-line (1L) approved therapies are indicated. * Participants must not have any symptomatic untreated central nervous system (CNS) metastases, leptomeningeal metastases (carcinomatous meningitis) or spinal cord compression. * Participants must not have any significant cardiovascular impairment as evidenced by uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias, or major thrombotic or embolic events or major hemorrhagic events (within 6 months prior to randomization), or significant risk of pulmonary hemorrhage. * Participants must not an active autoimmune disease. * Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcome measure(s)

Trial sites (279)

FacilityCityRegionStatus
Southern Cancer Center Pc Daphne Alabama Recruiting
Mohtaseb Cancer Center & Blood Disorders Bullhead City Arizona Recruiting
Palo Verde Hematology Oncology Glendale Arizona Recruiting
Beverly Hills Cancer Center Beverly Hills California Recruiting
Orange Coast Memorial Medical Center Fountain Valley California Recruiting
Local Institution - 0027 Los Alamitos California Not Yet Recruiting
Local Institution - 0422 Los Angeles California Not Yet Recruiting
Pacific Cancer Care Monterey California Recruiting
Local Institution - 0403 Oakland California Not Yet Recruiting
Local Institution - 0208 Pleasant Hill California Not Yet Recruiting
BASS Cancer Center Walnut Creek California Recruiting
Local Institution - 0340 Lakewood Colorado Not Yet Recruiting
Clermont Oncology Center Clermont Florida Recruiting
Advanced Research Coral Springs Florida Recruiting
BRP- Hialeah Hospital Hialeah Florida Recruiting
Florida Clinical Trials Group Tamarac Florida Recruiting
University Cancer & Blood Center, LLC Athens Georgia Recruiting
Local Institution - 0412 Augusta Georgia Not Yet Recruiting
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital Marietta Georgia Recruiting
Local Institution - 0423 Urbana Illinois Not Yet Recruiting
Northwest Cancer Centers, P.C. Dyer Indiana Recruiting
Missouri Cancer Associates Columbia Missouri Recruiting
Local Institution - 0224 Laurelton New York Not Yet Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Optum Medical Care, PC Westbury New York Recruiting
Novant Health Pharmacy Oncology Specialists Winston-Salem North Carolina Recruiting
Local Institution - 0383 Cincinnati Ohio Not Yet Recruiting
Local Institution - 0418 Oklahoma City Oklahoma Not Yet Recruiting
Lancaster General Hospital Lancaster Pennsylvania Recruiting
Local Institution - 0028 Pittsburgh Pennsylvania Not Yet Recruiting
WellSpan Oncology Research York Pennsylvania Recruiting
University Of Texas Medical Branch At Galveston Galveston Texas Recruiting
Kelsey-Seybold Clinic Main Campus Houston Texas Recruiting
Texas Oncology - San Antonio San Antonio Texas Recruiting
Local Institution - 0381 San Antonio Texas Not Yet Recruiting
Local Institution - 0337 Richmond Virginia Not Yet Recruiting
Shenandoah Oncology, P.C. Winchester Virginia Recruiting
Local Institution - 0384 Spokane Washington Not Yet Recruiting
Charleston Area Medical Center (CAMC) Charleston West Virginia Recruiting
HSHS St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin Recruiting

+ 239 more sites — see the full list on the official registry below.

On this site

📄 Keytruda (pembrolizumab) drug profile →

More Bristol-Myers Squibb trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07361510 on ClinicalTrials.gov ↗ ← All trials in the UK