Groupe d'Etude en Oncologie du Quebec

Title	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
Protocole ID	CodeBreaK 202
ClinicalTrials.gov ID	NCT05920356
Cancer Type(s)	Non Small Cells - Lung
Phase	Phase III
Stage
Study Type	Clinical
Drug	Sotorasib Platinum Doublet Combination versus Pembrolizumab Platinum Doublet Combination
Institution	CENTRE UNIVERSITAIRE DE SANTE MCGILL SITE GLEN 1001 boul. Décarie , Montréal, QC, H4A 3J1
City
Principal Investigator	Dr. Benjamin Shieh
Coordinator	Nicola Raby 514-934-1934 poste 34095
Status	Recruiting
Activation Date	02-05-2024
Eligibility 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

Groupe d'étude en oncologie du Québec