Studieoverzicht

Study name: ROSETTA Lung-202: A Randomized, Double-Blind, Phase 3 Study of Pumitamig Monotherapy Compared to Pembrolizumab as First-line Treatment in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With PD-L1 ≥ 50%.

Histology	NSCLC, all subtypes
Tumor stage	Stage III - IV
NCT Id	NCT07361510
Host / recruiting site 1	Jeroen Bosch Ziekenhuis	Enrollment	Planned
Host / recruiting site 2	Meander Medisch Centrum	Enrollment	Recruiting
Host / recruiting site 3	Radboud UMC	Enrollment	Recruiting
Host / recruiting site 4	ETZ Elisabeth	Enrollment	Recruiting
Therapy line	First line (1L)
PD-L1 expression	High: ≥50%
Design	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%.
Intervention	DRUG: Pumitamig Specified dose on specified days DRUG: Pembrolizumab Specified dose on specified days
Key inclusion 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.
Key exclusion criteria	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.
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