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: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
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
Mar 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
Southern Cancer Center Pc
Daphne, Alabama, United States, 36526
Status
Recruiting
Location
Local Institution - 0424
Bullhead City, Arizona, United States, 86442
Status
Not yet recruiting
Location
Local Institution - 0391
Glendale, Arizona, United States, 85304
Status
Not yet recruiting
Location
Local Institution - 0407
Anaheim, California, United States, 92801
Status
Not yet recruiting
Location
Local Institution - 0352
Beverly Hills, California, United States, 90211
Status
Not yet recruiting
Location
Orange Coast Memorial Medical Center
Fountain Valley, California, United States, 92708
Status
Recruiting
Go to page