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

Conditions studied: Non-Small Cell Lung Cancer (NSCLC)

In brief

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%.

Key facts

Study ID

NCT07361510

Run by

Bristol-Myers Squibb

People needed

750

Starts

2026-03-12

Expected to finish

2031-10-14

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

• Sanatorio Plaza — Rosario, Santa Fe Province, Argentina (enrolling)
• Nepean Hospital — Penrith, New South Wales, Australia (enrolling)
• Kelsey-Seybold Clinic Main Campus — Houston, Texas, United States (enrolling)
• Fundacion Estudios Clinicos — Rosario, Santa Fe Province, Argentina (enrolling)
• Gosford Hospital — Gosford, New South Wales, Australia (enrolling)
• Palo Verde Hematology Oncology — Glendale, Arizona, United States (enrolling)
• Mohtaseb Cancer Center & Blood Disorders — Bullhead City, Arizona, United States (enrolling)
• University Of Texas Medical Branch At Galveston — Galveston, Texas, United States (enrolling)
• Texas Oncology - San Antonio — San Antonio, Texas, United States (enrolling)
• HSHS St. Vincent Hospital Regional Cancer Center — Green Bay, Wisconsin, United States (enrolling)
• Orange Coast Memorial Medical Center — Fountain Valley, California, United States (enrolling)
• Clermont Oncology Center — Clermont, Florida, United States (enrolling)
• Advanced Research — Coral Springs, Florida, United States (enrolling)
• BRP- Hialeah Hospital — Hialeah, Florida, United States (enrolling)
• Florida Clinical Trials Group — Tamarac, Florida, United States (enrolling)
• University Cancer & Blood Center, LLC — Athens, Georgia, United States (enrolling)
• WellSpan Oncology Research — York, Pennsylvania, United States (enrolling)
• Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital — Marietta, Georgia, United States (enrolling)
• Southern Cancer Center Pc — Daphne, Alabama, United States (enrolling)
• Northwest Cancer Centers, P.C. — Dyer, Indiana, United States (enrolling)
• Missouri Cancer Associates — Columbia, Missouri, United States (enrolling)
• Shenandoah Oncology, P.C. — Winchester, Virginia, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Optum Medical Care, PC — Westbury, New York, United States (enrolling)
• Lyell McEwin Hospital — Elizabeth Vale, South Australia, Australia (enrolling)

Full record on ClinicalTrials.gov

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