Last updated 12 days ago
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)
750 patients around the world
Available in Chile, Peru, Argentina, United States, Mexico, Brazil, Colombia
Bristol-Myers Squibb
750Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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 have an active autoimmune disease.Other protocol-defined Inclusion/Exclusion criteria apply.
StudyROSETTA Lung-202
SponsorBristol-Myers Squibb
Study typeInterventional
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07361510
