Groupe d'Etude en Oncologie du Quebec

Titre	A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Canakinumab in Combination With Docetaxel Versus Placebo in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancer (NSCLC) Previously Treated With PD-(L)1 Inhibitors and Platinum-based Chemotherapy
Protocole ID	CANOPY 2
ClinicalTrials.gov ID	NCT03626545
Type(s) de cancer	Poumon non à petites cellules
Phase	Phase III
Stade	Maladie avancée ou métastatique
Type étude	Traitement
Médicament	Canakinumab avec Docetaxel
Institution	CENTRE UNIVERSITAIRE DE SANTE MCGILL SITE GLEN 1001 boul. Décarie , Montréal, QC, H4A 3J1
Ville	Montréal
Investigateur(trice) principal(e)	Dr Scott Owen
Coordonnateur(trice)	Corneille Bashagaluke 514-934-1934 poste 34907
Statut	Actif en recrutement
Critètes d'éligibilité	Histologically confirmed advanced (stage IIIB) or metastatic NSCLC. Subject has received one prior platinum-based chemotherapy and one prior PD-(L)1 inhibitor therapy for locally advanced or metastatic disease. Subject with ECOG performance status (PS) of 0 or 1. Subject with at least 1 evaluable (measurable or non-measurable) lesion by RECIST 1.1 in solid tumors criteria.
Critètes d'exclusion	Subject who previously received docetaxel, canakinumab (or another IL-1β inhibitor), or any systemic therapy for their locally advanced or metastatic NSCLC other than one platinum-based chemotherapy and one prior PD-(L)1 inhibitor. Subject with EGFRor ALK positive tumor. History of severe hypersensitivity reaction to monoclonal antibodies, taxanes or excipients of docetaxel or canakinumab. Other protocol-defined inclusion/exclusion may apply.

Groupe d'étude en oncologie du Québec