A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC

NCT05211895 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 860

Last updated 2026-05-18

No results posted yet for this study

Summary

This is a Phase III, randomised, double-blind, placebo-controlled, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) and domvanalimab (AB154) compared with durvalumab plus placebo in adults with locally advanced (Stage III), unresectable NSCLC whose disease has not progressed following definitive platinum-based cCRT.

Conditions

Interventions

DRUG

Durvalumab

Durvalumab IV (Intravenous infusion)

DRUG

Domvanalimab

Domvanalimab IV (Intravenous infusion)

OTHER

Placebo

Placebo IV (Intravenous infusion)

Sponsors & Collaborators

  • Arcus Biosciences, Inc.

    collaborator INDUSTRY
  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Hidehito Horinouchi, MD, PhD · National Cancer Center Hospital

  • Alexander Spira, MD, PhD · Virginia Cancer Specialists Research Institute

  • Jinming Yu, MD, PhD · Shandong Cancer Hospital and Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-18
Primary Completion
2028-07-12
Completion
2030-10-01
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Brazil
  • Canada
  • Chile
  • France
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • India
  • Italy
  • Japan
  • Malaysia
  • Mexico
  • Norway
  • Philippines
  • Poland
  • Romania
  • South Africa
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom
  • Vietnam

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05211895 on ClinicalTrials.gov