Poumon à petites cellules

TITRE	(EN) A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients With Limited Stage Small Cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy
PROTOCOLE ID	ADRIATIC
CLINICAL TRIAL.gov ID	NCT03703297
TYPE(S) DE CANCER	Poumon 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
CRITÈRES D'ÉLIGIBILITÉ	(EN) Histologically or cytologically documented limited-stage small cell lung cancer (stage I-III). Received 4 cycles of chemotherapy concurrent with radiotherapy, which must be completed within 1 to 42 days prior to randomization and the first dose of IP. Chemotherapy must contain platinum and IV etoposide. Radiotherapy must be either total 60-66 Gy over 6 weeks for the standard QD regimen or total 45 Gy over 3 weeks for hyperfractionated BD schedules. PCI may be delivered at the discretion of investigator and local standard of care, and must be conducted after the end of cCRT and completed between 1 to 42 days to first dose of IP. Have not progressed following definitive concurrent chemoradiation 5 .Life expectancy ≥ 12 weeks at Day 1. 6. ECOG 0 or 1 at enrolment.
CRITÈRES D'EXCLUSION	(EN) Extensive-stage SCLC Active or prior documented autoimmune or inflammatory disorders Uncontrolled intercurrent illness, including but not limited to interstitial lung disease. Active infection including tuberculosis, HIV, hepatitis B and C Patients who received sequential chemotherapy and radiotherapy (no overlap of RT with chemotherapy)