Study identifier:D933YC00001
ClinicalTrials.gov identifier:NCT03706690
EudraCT identifier:2018-002294-22
CTIS identifier:N/A
A Phase III, Randomised,Double-Blind,Placebo-Controlled,Study of Durvalumab as Consolidation Therapy in Patients with Locally Advanced,Unresectable NSCLC, Who Have Not Progressed following Definitive, Platinum-Based Chemoradiation Therapy
Carcinoma, Non-Small-Cell Lung
Phase 3
No
Durvalumab
All
407
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Nov 2024 by AstraZeneca
AstraZeneca
-
This is a Phase III, randomised, double-blind, placebo-controlled, multicentre study assessing the efficacy and safety of durvalumab compared with placebo, as consolidation therapy in patients with locally advanced, unresectable, non-small cell lung cancer (Stage III), who have not progressed following definitive, platinum-based, chemoradiation therapy.
Approximately 400 patients will be randomized in a 2:1 to receive treatment with durvalumab or placebo therapy. The primary objective of this study is to assess the efficacy of durvalumab treatment compared with placebo in terms of PFS.
Location
Location
Changchun, China, 130000
Location
Guangzhou, China, 510100
Location
Beijing, China, 100730
Location
Wuhan, China, 430030
Location
Changsha, China, 410013
Location
Yangzhou, China, 225001
Location
Hangzhou, China, 310022
Location
hangzhou, China, 310006
Arms | Assigned Interventions |
---|---|
Experimental: Durvalumab Therapy Durvalumab (PD-L1 monoclonal antibody)1500 mg every 4 weeks [q4w] intravenously [iv] until clinical progression/deterioration or confirmed radiological progression) | Drug: Durvalumab Durvalumab 1500 mg every 4 weeks [q4w] intravenously [iv] until clinical progression/ deterioration or confirmed radiological progression. Other Name: MEDI4736 |
Placebo Comparator: Placebo Therapy Placebo (matching placebo for infusion every 4 weeks iv until clinical progression/deterioration or confirmed radiological progression) | Other: Placebo Matching placebo for infusion every 4 weeks iv until clinical progression/deterioration or confirmed radiological progression Other Name: Placebo |
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