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)
NCT05920356 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 750
Last updated 2026-05-22
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.
Conditions
- Non-Small Cell Lung Cancer (NSCLC)
Interventions
- DRUG
-
Sotorasib
Oral administration
- DRUG
-
Intravenous administration
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
MD · Amgen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-16
- Primary Completion
- 2027-06-30
- Completion
- 2032-06-29
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Austria
- Belgium
- Brazil
- Bulgaria
- Canada
- Chile
- China
- Colombia
- Czechia
- Denmark
- France
- Germany
- Greece
- Hong Kong
- Hungary
- Italy
- Japan
- Latvia
- Malaysia
- Mexico
- Netherlands
- Peru
- Poland
- Portugal
- Puerto Rico
- Romania
- Singapore
- South Korea
- Spain
- Sweden
- Switzerland
- Taiwan
- Thailand
- Turkey (Türkiye)
- United Kingdom
Study Locations
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