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)
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%.
Checked against the public recordLast updated Aug 10, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Bristol-Myers Squibb
- Interventions being studied
- Drug: Pumitamig; Drug: Pembrolizumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Southern Cancer Center PcDaphne, Alabama
- Mohtaseb Cancer Center & Blood DisordersBullhead City, Arizona
- Palo Verde Hematology OncologyGlendale, Arizona
- Local Institution - 0407Anaheim, California
- Local Institution - 0352Beverly Hills, California
- Orange Coast Memorial Medical CenterFountain Valley, California
- Local Institution - 0027Los Alamitos, California
- Local Institution - 0422Los Angeles, California
- Local Institution - 0403Oakland, California
- Local Institution - 0208Pleasant Hill, California
- BASS Cancer CenterWalnut Creek, California
- Local Institution - 0340Lakewood, Colorado
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 10, 2026. Always confirm current availability with the study team.