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
| Parameter | Options |
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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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Southern Cancer Center Pc | 36526 | Daphne | Alabama |
| Local Institution - 0424 | 86442 | Bullhead City | Arizona |
| Local Institution - 0391 | 85304 | Glendale | Arizona |
| Local Institution - 0407 | 92801 | Anaheim | California |
| Local Institution - 0352 | 90211 | Beverly Hills | California |
| Orange Coast Memorial Medical Center | 92708 | Fountain Valley | California |
| Local Institution - 0027 | 90720 | Los Alamitos | California |
| Local Institution - 0422 | 90095 | Los Angeles | California |
| Local Institution - 0403 | 94611 | Oakland | California |
| Local Institution - 0208 | 94523 | Pleasant Hill | California |
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