Poumon non à petites cellules

TITRE	(EN) 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
CLINICAL TRIAL.gov ID	NCT05920356
TYPE(S) DE CANCER	Poumon non à petites cellules
PHASE	Phase III
TYPE D'ÉTUDE	Clinique
INSTITUTION	INSTITUT UNIVERSITAIRE DE CARDIOLOGIE ET DE PNEUMOLOGIE 272, chemin Sainte-Foy (418) 656-8711
VILLE	Québec
INVESTIGATEUR(RICE) PRINCIPAL(E)	Catherine Labbé
COORDONATEUR(RICE)	Brigitte Fortin brigitte.fortin@criucpq.ulaval.ca 418-656-8711 poste 2639 Marie-Ève Morneau marie-eve.morneau@criucpq.ulaval.ca 418-656-8711 poste 2690
STATUT	Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ	(EN) 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
CRITÈRES D'EXCLUSION	(EN) 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