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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)
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)

NCT07361510

RecruitingPhase 3

Sponsor: Bristol-Myers Squibb

Conditions: Non-Small Cell Lung Cancer (NSCLC)

Interventions: Pumitamig, Pembrolizumab

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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 (278)
  • Daphne, Alabama, United States
  • Bullhead City, Arizona, United States
  • Glendale, Arizona, United States
  • Anaheim, California, United States
  • Beverly Hills, California, United States
  • Fountain Valley, California, United States
  • Los Alamitos, California, United States
  • Los Angeles, California, United States
  • Oakland, California, United States
  • Pleasant Hill, California, United States
  • Walnut Creek, California, United States
  • Lakewood, Colorado, United States
  • Clermont, Florida, United States
  • Coral Springs, Florida, United States
  • Hialeah, Florida, United States
  • Tamarac, Florida, United States
  • Athens, Georgia, United States
  • Augusta, Georgia, United States
  • Marietta, Georgia, United States
  • Urbana, Illinois, United States
  • Dyer, Indiana, United States
  • Columbia, Missouri, United States
  • Laurelton, New York, United States
  • New York, New York, United States
  • Westbury, New York, United States
  • Winston-Salem, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Oklahoma City, Oklahoma, United States
  • Lancaster, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • + 248 more on CT.gov