Clinical Trial

A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)

Recruiting Phase 3
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Summary
The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.
Protocol Amendment History 4 changes
notable Trial sites expanded: 383 -> 401 locations 2026-07-17
notable Trial sites expanded: 380 -> 383 locations 2026-05-15
notable Primary completion pushed: 2026-06-30 -> 2027-06-30 2026-04-21
minor Completion pushed: 2031-06-30 -> 2032-06-29 2026-04-21
Trial Details
NCT Number NCT05920356
Lead Sponsor Amgen
Conditions Non-Small Cell Lung Cancer (NSCLC)
Enrollment 750 participants
Start Date 2023-11-16
Primary Completion 2027-06-30 (estimated)
Study Completion 2032-06-29 (estimated)
Updated on ClinicalTrials.gov 2026-07-16