Groupe d'Etude en Oncologie du Quebec

Title	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
ClinicalTrials.gov ID	NCT03703297
Cancer Type(s)	Small Cells - Lung
Phase	Phase III
Stage
Study Type	Treatment
Drug	Durvalumab ou Durvalumab et Tremelimumab en traitement de consolidation
Institution	CENTRE UNIVERSITAIRE DE SANTE MCGILL SITE GLEN 1001 boul. Décarie , Montréal, QC, H4A 3J1
City
Principal Investigator	Dr. Scott Owen
Coordinator	Corneille Bashagaluke 514-934-1934 poste 34907
Status	Recruiting
Activation Date
Eligibility Criteria	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.
Exclusion Criteria	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)

Groupe d'étude en oncologie du Québec