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)

Bristol-Myers Squibb (BMS)

Status and phase: Begins enrollment in 2 months; Phase 3

Conditions: Non-Small Cell Lung Cancer (NSCLC)

Treatments: Drug: Pumitamig; Drug: Pembrolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07361510

U1111-1326-9286 (Other Identifier)

2025-523586-18 (Other Identifier)

CA266-0002

Details and patient eligibility

About

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%.

Enrollment: 750 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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750 participants in 2 patient groups

Arm A: Pumitamig

Experimental group

Treatment:

Drug: Pumitamig

Arm B: Pembrolizumab

Active Comparator group

Treatment:

Drug: Pembrolizumab