Poumon non à petites cellules

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TITRE (EN) 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
CLINICAL TRIAL.gov ID NCT03626545
TYPE(S) DE CANCER Poumon non à petites cellules
PHASE Phase III
TYPE D'ÉTUDE Traitement
INSTITUTION CENTRE UNIVERSITAIRE DE SANTE MCGILL
1001 boul. Décarie
VILLE Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E) Scott Owen
COORDONATEUR(RICE) Corneille Bashagaluke
corneille.bashagaluke@muhc.mcgill.ca
514-934-1934 poste 34907
STATUT  Fermé
DATE D'ACTIVATION
CRITÈRES D'ÉLIGIBILITÉ (EN)
  • 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.
CRITÈRES D'EXCLUSION (EN)
  • 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.