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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Page 1 of 68 (271 locations)

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