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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)

StatusRecruiting
PhasePhase 3
SponsorAmgen
Started2023-11-16
View on ClinicalTrials.gov ↗
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.

Amendment history 6 changes detected by DataLookout

2026-08-14
minor
Trial sites expanded: 407 → 412 locations
2026-08-07
minor
Trial sites expanded: 404 → 407 locations
2026-07-17
minor
Trial sites expanded: 383 → 401 locations
2026-05-15
minor
Trial sites expanded: 380 → 383 locations
2026-04-21
critical
Primary completion pushed: 2026-06-30 → 2027-06-30
2026-04-21
minor
Completion pushed: 2031-06-30 → 2032-06-29
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 2026-08-27