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)

Trial status:Will Be Recruiting
Trial ID:
CA266-0002
NCT ID:
NCT07361510
EudraCT ID:
N/A
EU Trial (CTIS) Number:
2025-523586-18
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
Bristol-Myers Squibb
Collaborator:
BioNTech SE
Will Be Recruiting

Trial Details

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%.

Medical Condition
  • Lung Cancer
    • Study Drug
  • Pumitamig
    • See more
  • Pembrolizumab
    • Phase
    Phase 3
    Type
    Interventional
    Estimated Enrolment
    750
    Estimated Trial Date
    Apr 2026 - Oct 2031

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Female & Male
    Healthy Volunteers
    No
    Inclusion and Exclusion Criteria
    Inclusion criteria

      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.

    Trial Locations

    Location
    Status
    Location
    Local Institution - 0348
    Mobile, Alabama, United States, 36607
    Status
    Location
    Local Institution - 0352
    Beverly Hills, California, United States, 90211
    Status
    Location
    Local Institution - 0027
    Los Alamitos, California, United States, 90720
    Status
    Location
    Local Institution - 0208
    Pleasant Hill, California, United States, 94523
    Status
    Location
    Local Institution - 0340
    Lakewood, Colorado, United States, 80401
    Status
    Location
    Local Institution - 0192
    Clermont, Florida, United States, 34711
    Status
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