Study Comparing Pumitamig and Pembrolizumab for Untreated Advanced Non-Small Cell Lung Cancer with High PD-L1 Levels

Sponsor: Bristol-Myers Squibb

Sponsor score: 60

ClinicalTrials ID:NCT07361510

This clinical trial is testing two different treatments, Pumitamig and Pembrolizumab, to see which is more effective for patients with advanced Non-Small Cell Lung Cancer who have not received any prior treatment and have high levels of PD-L1.

Patient Parameters

Program Overview

The goal of this study is to compare the effectiveness of two treatments, Pumitamig and Pembrolizumab, in patients with advanced Non-Small Cell Lung Cancer (NSCLC) who have not been treated before and have a PD-L1 level of 50% or higher. PD-L1 is a protein that can affect how the immune system responds to cancer, and higher levels may influence treatment options.

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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