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%

未提供0 个研究点目标入组 50 人开始时间: 待定

试验速览

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•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.
•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 an active autoimmune disease.
•Other protocol-defined Inclusion/Exclusion criteria apply.

发起方

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