RecruitingPhase 3NCT07361510

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

StatusRecruiting
PhasePhase 3
U.S. locations278
SponsorBristol-Myers Squibb
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Bristol-Myers Squibb
Interventions being studied
Drug: Pumitamig; Drug: Pembrolizumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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