NCT03706690

A Study of Durvalumab as Consolidation Therapy in Non-Small Cell Lung Cancer Patients

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 407 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Durvalumab	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

Timeline

• Start date: 2018-11-27
• Primary completion: 2024-06-23
• Completion: 2027-02-26
• First posted: 2018-10-16
• Last updated: 2026-03-02
• Results posted: 2025-02-12

Locations

87 sites across 10 countries: China, Hong Kong, India, Mexico, Philippines, Poland, Russia, South Korea, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study