Tests sotorasib with chemotherapy against pembrolizumab with chemotherapy in lung cancer
Tests sotorasib with chemotherapy in adults with advanced KRAS G12C lung cancer.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Albuquerque, Asheville, Chicago, Coral Springs, Dayton, Durham, Houston, Janesville, Knoxville, Lancaster, Louisville, Media, Memphis, Miami, Nashville, New York, Newark, Niles, Olympia, Pinehurst, Pittsburgh, Santa Barbara, Sayre, Tamarac, Waterloo, and Worcester, United StatesSee the 27 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
- Which best describes your lung cancer?
- Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
- What was the PD-L1 result of your tumour test?
- Has your cancer spread to the brain?
Source: NCT05920356, who can take part
Where in United States
- University of New Mexico Cancer CenterAlbuquerque, United StatesTaking people
- Messino Cancer Centers AshevilleAsheville, United StatesTaking people
- University of Illinois ChicagoChicago, United StatesTaking people
- Boca Raton Clinical Research Coral SpringsCoral Springs, United StatesTaking people
- Dayton Physician's NetworkDayton, United StatesTaking people
- Duke University Medical Center - Duke Cancer CenterDurham, United StatesTaking people
- Oncology Consultants, PAHouston, United StatesTaking people
- University of Texas - MD Anderson Cancer CenterHouston, United StatesTaking people
- MercyhealthJanesville, United StatesTaking people
- University of Tennessee Medical Center KnoxvilleKnoxville, United StatesNo longer taking part
- Medical University of South Carolina Health Lancaster Medical CenterLancaster, United StatesTaking people
- Norton Cancer Institute - BrownsboroLouisville, United StatesNo longer taking part
- Alliance Cancer Specialists - MediaMedia, United StatesTaking people
- Regional One HealthMemphis, United StatesTaking people
- Regis Clinical Research LLCMiami, United StatesTaking people
- Sarah Cannon Research InstituteNashville, United StatesTaking people
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesNo longer taking part
- Medical Oncology Hematology Consultants Helen F Graham Cancer CenterNewark, United StatesTaking people
- Illinois Cancer SpecialistsNiles, United StatesTaking people
- Vista Oncology Inc PSOlympia, United StatesTaking people
- FirstHealth Cancer CenterPinehurst, United StatesTaking people
- University of Pittsburgh Medical Center - Hillman Cancer CenterPittsburgh, United StatesNo longer taking part
- Sansum ClinicSanta Barbara, United StatesTaking people
- Guthrie Medical GroupSayre, United StatesTaking people
- Florida Clinical Trials Group - TamaracTamarac, United StatesTaking people
- Medical University of South CarolinaWaterloo, United StatesTaking people
- Reliant Medical Group IncWorcester, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Amgen
- Trial code
- NCT05920356EU 2022-501863-41-00
- Record updated
- 6 November 2026
- Original description
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.Read full original descriptionShow less
A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)
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.
Inclusion: Histologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing; No history of systemic anticancer therapy in metastatic/non-curable settings; Eastern Cooperative Oncology Group (ECOG) ≤ 1.
Exclusion: Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved as a front-line therapy; Prior therapy with a KRAS G12C inhibitor; Gastrointestinal (GI) tract disease causing the inability to take oral medication; Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina; Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology; Symptomatic (treated or untreated) brain metastases.