A Study of Durvalumab as Consolidation Therapy in Non-Small Cell Lung Cancer Patients (PACIFIC-5)

A Study of Durvalumab as Consolidation Therapy in Non-Small Cell Lung Cancer Patients (PACIFIC-5)

Brief 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 360 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.


Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Sponsor, excluding supply chain management personnel and unblinded monitors of site pharmacies, will remain blinded.
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date: November 27, 2018
Estimated Primary Completion Date: November 25, 2022
Estimated Study Completion Date: March 4, 2025

Arm:
- Experimental: Durvalumab Therapy
- Placebo Comparator: Placebo Therapy

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