Poumon non à petites cellules

TITRE	(EN) A Phase III, Double-blind, Placebo-controlled, Randomised, Multicentre, International Study of Durvalumab Plus Oleclumab and Durvalumab Plus Monalizumab in Patients With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Definitive, Platinum-Based Concurrent Chemoradiation Therapy
PROTOCOLE ID	PACIFIC-9
CLINICAL TRIAL.gov ID	NCT05221840
TYPE(S) DE CANCER	Poumon non à petites cellules
PHASE	Phase III
TYPE D'ÉTUDE	Clinique
INSTITUTION	CSSS DE RIMOUSKI-NEIGETTE 150 av. Rouleau (418) 724-3000
VILLE	Rimouski
INVESTIGATEUR(RICE) PRINCIPAL(E)	Arnaud Blanchet-St-Pierre
COORDONATEUR(RICE)	Isabelle Gagnon isabelle.gagnon0109.cisssbsl@ssss.gouv.qc.ca 418-724-3000 poste 8029
STATUT	Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ	(EN) Participant must be ≥ 18 years at the time of screening. Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease Provision of a tumour tissue sample obtained prior to CRT Documented tumour PD-L1 status by central lab Documented EGFR and ALK wild-type status (local or central). Patients must not have progressed following definitive, platinum based, concurrent chemoradiotherapy Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy Participants must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66 Gy) as part of the chemoradiation therapy, to be randomised. Radiation therapy should be administered by intensity modulated RT (preferred) or 3D-conforming technique. WHO performance status of 0 or 1 at randomization Adequate organ and marrow function
CRITÈRES D'EXCLUSION	(EN) History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥5 years before the first dose of study intervention and of low potential risk for recurrence, adequately resected non-melanoma skin cancer and curatively treated in situ disease, or adequately treated carcinoma in situ or Ta tumours without evidence of disease. Mixed small cell and non-small cell lung cancer histology. Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC. Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT. Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy (excluding alopecia). Participants with ≥grade 2 pneumonitis from prior chemoradiation therapy. History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or idiopathic pneumonitis - regardless of time of onset prior to randomisation. Evidence of active non-CRT induced pneumonitis (≥ Grade 2), active pneumonia, active ILD, active or recently treated pleural effusion, or current pulmonary fibrosis - diagnosed in the past 6 months prior to randomization. Active or prior documented autoimmune or inflammatory disorders (with exceptions) Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.