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 now · Phase 3
Conditions studied: Non-Small Cell Lung Cancer (NSCLC)
In brief
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.
Key facts
- Study ID
- NCT05920356
- Run by
- Amgen
- People needed
- 750
- Starts
- 2023-11-16
- Expected to finish
- 2032-06-29
- Last updated by the study team
- 2026-08-06
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology
- Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved as a front-line therapy
- Symptomatic (treated or untreated) brain metastases
- Gastrointestinal (GI) tract disease causing the inability to take oral medication
- Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina
- Prior therapy with a KRAS G12C inhibitor
Where it is running
- Instituto Argentino de Diagnostico y Tratamiento IADT — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina (enrolling)
- Clinica Viedma — Viedma, Río Negro Province, Argentina (enrolling)
- Sansum Clinic — Santa Barbara, California, United States (enrolling)
- Medical Oncology Hematology Consultants Helen F Graham Cancer Center — Newark, Delaware, United States (enrolling)
- Hospital Italiano de La Plata — La Plata, Buenos Aires, Argentina (enrolling)
- Fundacion Ars Medica — San Salvador de Jujuy, Jujuy Province, Argentina (enrolling)
- Illinois Cancer Specialists — Niles, Illinois, United States (enrolling)
- Messino Cancer Centers Asheville — Asheville, North Carolina, United States (enrolling)
- Duke University Medical Center — Durham, North Carolina, United States (enrolling)
- FirstHealth Cancer Center — Pinehurst, North Carolina, United States (enrolling)
- Reliant Medical Group Inc — Worcester, Massachusetts, United States (enrolling)
- Alliance Cancer Specialists - Media — Media, Pennsylvania, United States (enrolling)
- University of New Mexico Cancer Center — Albuquerque, New Mexico, United States (enrolling)
- University of Illinois Chicago — Chicago, Illinois, United States (enrolling)
- Regional One Health — Memphis, Tennessee, United States (enrolling)
- Sarah Cannon Research Institute — Nashville, Tennessee, United States (enrolling)
- United States Oncology Regulatory Affairs Corporate Office — Nashville, Tennessee, United States (enrolling)
- Oncology Consultants PA — Houston, Texas, United States (enrolling)
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- US Oncology Research Investigational Products Center — Irving, Texas, United States (enrolling)
- Vista Oncology Inc PS — Olympia, Washington, United States (enrolling)
- Mercyhealth — Janesville, Wisconsin, United States (enrolling)
- Dayton Physician's Network — Dayton, Ohio, United States (enrolling)
- Instituto Alexander Fleming — Capital Federal, Buenos Aires, Argentina (enrolling)
- Fundacion Estudios Clinicos — Rosario, Santa Fe Province, Argentina (enrolling)
Full record on ClinicalTrials.gov
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