Status:
RECRUITING
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)
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
BioNTech SE
Conditions:
Non-Small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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%.
Eligibility 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.
Key Trial Info
Start Date :
March 12 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 14 2031
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT07361510
Start Date
March 12 2026
End Date
October 14 2031
Last Update
April 15 2026
Active Locations (271)
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1
Local Institution - 0348
Daphne, Alabama, United States, 36526
2
Local Institution - 0424
Bullhead City, Arizona, United States, 86442
3
Local Institution - 0391
Glendale, Arizona, United States, 85304
4
Local Institution - 0407
Anaheim, California, United States, 92801