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%.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 23, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Interventional
Locations may change over time.
Study sponsor
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
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.
- 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/
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
- Beverly Hills Cancer CenterBeverly Hills, California
- Orange Coast Memorial Medical CenterFountain Valley, California
- Cancer and Blood Specialty ClinicLos Alamitos, California
- UCLALos Angeles, California
- Pacific Cancer CareMonterey, 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: Oct 23, 2026. Always confirm current availability with the study team.