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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)

RecruitingPhase 3Ages 18 Years - 100 YearsAllAmgen
NCT05920356 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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
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What it tests

  • Sotorasib
  • Pembrolizumab
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Where

424 sites
Sansum Clinic
Santa Barbara, United States
Medical Oncology Hematology Consultants Helen F Graham Cancer Center
Newark, United States
Boca Raton Clinical Research Coral Springs
Coral Springs, United States
Regis Clinical Research LLC
Miami, United States
Florida Clinical Trials Group Plantation
Plantation, United States
Florida Clinical Trials Group Tamarac
Tamarac, United States
University of Illinois Chicago
Chicago, United States
Illinois Cancer Specialists
Niles, United States

…and 416 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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