Groupe d'Etude en Oncologie du Quebec

Titre	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
Type(s) de cancer	Poumon non à petites cellules
Phase	Phase III
Type étude	Clinique
Médicament	Sotorasib Platinum Doublet Combination versus Pembrolizumab Platinum Doublet Combination
Institution	CIUSSS DU NORD-DE-L'ILE-DE-MONTREAL HOPITAL DU SACRE-COEUR-DE-MONTREAL 5400 boul. Gouin Ouest, Montréal, QC, H4J1C5
Ville	Montréal
Investigateur(trice) principal(e)	Dr Kevin Jao
Coordonnateur(trice)
Statut	Actif en recrutement
Date d'activation	17-05-2024
Critètes d'éligibilité	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
Critètes d'exclusion	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