A Study of Durvalumab as Consolidation Therapy in Non-Small Cell Lung Cancer Patients
NCT03706690 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 407
Last updated 2026-05-13
Summary
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.
Conditions
- Carcinoma, Non-Small-Cell Lung
Interventions
- DRUG
-
Durvalumab 1500 mg every 4 weeks \[q4w\] intravenously \[iv\] 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
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Yilong Wu, MD · Guangdong General Hospital, Guangdong Lung Cancer Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 130 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-11-27
- Primary Completion
- 2024-06-23
- Completion
- 2027-02-26
- FDA Drug
- Yes
Countries
- China
- Hong Kong
- India
- Mexico
- Philippines
- Poland
- Russia
- South Korea
- Taiwan
- Turkey (Türkiye)
Study Locations
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