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)

Sponsor: Bristol-Myers Squibb

Sponsor score: 60

ClinicalTrials ID:NCT07361510

The ROSETTA Lung-202 trial assesses the efficacy of Pumitamig compared to Pembrolizumab in treating advanced NSCLC with PD-L1 ≥ 50%. Participants receive specified doses of either Pumitamig or Pembrolizumab. Eligibility includes individuals with previously untreated advanced NSCLC and high PD-L1 expression. The study aims to determine which treatment offers superior outcomes in this patient population.

Patient Parameters

Program Overview

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.

Locations

FACILITYZIPCITYSTATE
Southern Cancer Center Pc36526DaphneAlabama
Local Institution - 042486442Bullhead CityArizona
Local Institution - 039185304GlendaleArizona
Local Institution - 040792801AnaheimCalifornia
Local Institution - 035290211Beverly HillsCalifornia
Orange Coast Memorial Medical Center92708Fountain ValleyCalifornia
Local Institution - 002790720Los AlamitosCalifornia
Local Institution - 042290095Los AngelesCalifornia
Local Institution - 040394611OaklandCalifornia
Local Institution - 020894523Pleasant HillCalifornia

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