Groupe d'Etude en Oncologie du Quebec

Titre	A Randomized, Controlled, Open Label, Phase III Study Evaluating the Efficacy and Safety of JDQ443 Versus Docetaxel in Previously Treated Subjects With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer
Protocole ID	KontRASt-02
ClinicalTrials.gov ID	NCT05132075
Type(s) de cancer	Poumon non à petites cellules
Phase	Phase III
Stade	Maladie avancée ou métastatique
Type étude	Clinique
Médicament	JDQ443 versus docétaxel
Institution	CENTRE UNIVERSITAIRE DE SANTE MCGILL SITE GLEN 1001 boul. Décarie , Montréal, QC, H4A 3J1
Ville	Montréal
Investigateur(trice) principal(e)	Dr Benjamin Shieh
Coordonnateur(trice)	Nicola Raby 514-934-1934 poste 34095 Sarah Boujan 514-934-1934 poste 34907
Statut	Actif en recrutement
Date d'activation	19-05-2023
Critètes d'éligibilité	Participant has histologically confirmed locally advanced/metastatic (stage IIIB/IIIC or IV) Participant has a KRAS G12C mutation present in tumor tissue prior to enrollment, as determined by a Novartis designated central laboratory. Participants has received one prior platinum-based chemotherapy regimen and one prior immune checkpoint inhibitor therapy for locally advanced or metastatic disease Participant has at least 1 evaluable (measurable or non-measurable) lesion by RECIST 1.1 at the screening visit.
Critètes d'exclusion	Participant has previously received docetaxel, KRAS G12C inhibitor or any other systemic therapy for their locally advanced or metastatic NSCLC other than one platinum-based chemotherapy and one prior immune check point inhibitor Participant has EGFR-sensitizing mutation and/or ALK rearrangement by local laboratory testing. Participants with other druggable alterations will be excluded if required by local guidelines. Participant has known active central nervous system (CNS) metastases and/or carcinomatous meningitis Participant has an history of interstitial lung disease or pneumonitis grade > 1. Other inclusion/exclusion criteria may apply

Groupe d'étude en oncologie du Québec