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)
Recruiting now Phase 3 NCT07361510
Run by Bristol-Myers Squibb · for 18 and older · All sexes
What this study is about
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%.
Who can join (things the study team will check)
✅ You may be able to join if…
- 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.
🚫 You may not be able to join if…
- 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.
Where this trial is running
- Southern Cancer Center Pc, Daphne, Alabama, United States
- Mohtaseb Cancer Center & Blood Disorders, Bullhead City, Arizona, United States
- Palo Verde Hematology Oncology, Glendale, Arizona, United States
- Local Institution - 0407, Anaheim, California, United States
- Local Institution - 0352, Beverly Hills, California, United States
- Orange Coast Memorial Medical Center, Fountain Valley, California, United States
- Local Institution - 0027, Los Alamitos, California, United States
- Local Institution - 0422, Los Angeles, California, United States
- Local Institution - 0403, Oakland, California, United States
- Local Institution - 0208, Pleasant Hill, California, United States
- Local Institution - 0416, Walnut Creek, California, United States
- Local Institution - 0340, Lakewood, Colorado, United States
+ 260 more sites.
Who to contact
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · 855-907-3286 · Clinical.Trials@bms.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07361510.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.
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