Trial details
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
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Trial short name: Codebreak 202
Official 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
Principal Investigator: Dr. Susanna Cheng
Cancer type: Lung
Cancer location: Lung
Disease stage: Early Cancer
Trial phase: Phase 3
Intervention: Drug: Sotorasib, Drug: Pembrolizumab
Registration #:
NCT05920356 
Contact e-mail: cancerclinicaltrials@sunnybrook.ca
Trial description:
The primary objective of this study is to compare progression-free survival (PFS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.
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 • 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
