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

Phase 3 Active not recruiting 407 enrolled AstraZeneca

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2018-11-27
Primary completion: 2024-06-23
Completion: 2027-02-26

Outcome

Met primary endpoint

registry analysis (superiority test); Durvalumab vs Placebo; p = 0.038; Hazard Ratio (HR) 0.75 (95% CI 0.578 to 0.986); Log Rank NCT03706690 ↗

paper CONCLUSIONS: PACIFIC-5 met its primary endpoint of improved PFS after either cCRT or sCRT. PMID 41354932 ↗

Publications

Wu YL, Wu L, Bi N, Cil T, Ge H, Zhu Z, Wang CL, Zhang W, Lv D, Mingyan E, Sun J, Pan Y, Krzakowski M, Dikilitas M, Sendur MAN, Kim YC, Yang Y, Mao R, Zhang B, Wang L. PACIFIC-5: a phase III clinical trial of consolidation durvalumab in patients with unresectable stage III NSCLC and no progression after concurrent or sequential chemoradiotherapy. J Hematol Oncol. 2025 Dec 7;18(1):111. doi: 10.1186/s13045-025-01768-1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Durvalumab	Monoclonal antibody	1500 mg	Intravenous