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%
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%
This is a phase 3 study of pumitamig compared to pembrolizumab in participants with locally advanced or metastatic non-small cell lung cancer with PD-L1 biomarker expression >= 50%.
Inclusion Criteria:
1. Patients with histologically confirmed diagnosis of NSCLC (squamous and non-squamous) with stage IIIB/IIIC or stage IV disease and PD-L1 expression >= 50%.
2. Patients 18 years of age or older.
3. Patients with an ECOG performance status of 0-1.
Exclusion Criteria:
1. Patients with tumors that exhibit mixed histologies including small cell components and sarcomatoid components or with symptomatic untreated CNS metastases or letomeningeal metastases.