Informations générales (source: ClinicalTrials.gov)
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 (PACIFIC-9)
Interventional
Phase 3
AstraZeneca (Voir sur ClinicalTrials)
février 2022
mai 2030
10 décembre 2024
This is a Phase III, randomised, double-blind, multicentre, international study assessing
the efficacy and safety of durvalumab (MEDI4736) in combination with oleclumab (MEDI9447)
or durvalumab (MEDI4736) with monalizumab (IPH2201) in adults with locally advanced
(Stage III), unresectable NSCLC, who have not progressed following platinum-based cCRT.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Christos CHOUAID | 29/03/2024 01:30:03 | Contacter | ||
| CLCC INSTITUT GUSTAVE ROUSSY | Fabrice BARLESI | 18/03/2024 11:06:17 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Research Site - 13015 - Marseille Cedex 20 - France | Contact (sur clinicalTrials) | ||||
| Research Site - 25030 - Besançon Cedex - France | Contact (sur clinicalTrials) | ||||
| Research Site - 31059 - Toulouse CEDEX 09 - France | Contact (sur clinicalTrials) | ||||
| Research Site - 33075 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Research Site - 34298 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Research Site - 35033 - Rennes - France | Contact (sur clinicalTrials) | ||||
| Research Site - 56322 - Lorient cedex - France | Contact (sur clinicalTrials) | ||||
| Research Site - 63000 - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
| Research Site - 75005 - Paris Cedex 5 - France | Contact (sur clinicalTrials) | ||||
| Research Site - 76031 - Rouen - France | Contact (sur clinicalTrials) | ||||
| Research Site - 84918 - Avignon Cedex 9 - France | Contact (sur clinicalTrials) | ||||
| Research Site - 94010 - Creteil Cedex - France | Contact (sur clinicalTrials) | ||||
| Research Site - 94805 - Villejuif Cedex - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
INCLUSION CRITERIA:
- 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
- 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
- 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.