CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 860 target
Drug / intervention
Durvalumab +2 moredrug
Likely dose
Not stated in record
Key inclusion· 10
  • ✓≥18 years old at screening
  • ✓Histologically or cytologically documented NSCLC treated with concurrent CRT for locally advanced unresectable Stage III disease
  • ✓Tumor tissue sample provided prior to CRT
  • ✓PD-L1 status ≥1% by central lab
Key exclusion· 10
  • ✕History of another primary malignancy (with exceptions for low-risk malignancies treated with curative intent, resected non-melanoma skin cancer, or treated carcinoma in situ)
  • ✕Mixed small cell and non-small cell lung cancer histology
  • ✕Sequential (not concurrent) chemoradiation therapy for stage III unresectable NSCLC
  • ✕Progression during platinum-based concurrent chemoradiotherapy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05211895
NCT05211895Phase 3RecruitingHigh Momentum
Long Recruiting
CompareCT.gov

A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre, International Study of Durvalumab Plus Domvanalimab(AB154) in Participants With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer Whose Disease Has Not Progressed Following Definitive Platinum-based Concurrent Chemoradiation Therapy

AstraZeneca·interventional·Posted Jan 27, 2022·Updated Jun 10, 2026

In Brief

A Phase 3 clinical trial evaluating Durvalumab, Domvanalimab, and 1 other intervention for Non-Small Cell Lung Cancer. Currently recruiting, targeting 860 participants across 264 sites in 28 countries.

Signals

Enrolling ahead of pace

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Cancer
CountriesBelgium, 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, United States, Vietnam
CollaboratorsArcus Biosciences, Inc.

Timeline

Phase 3Recruiting
202220232024202520262027202820292030
First PostedJan 27, 2022
Enrollment StartFeb 18, 2022
Primary CompletionJul 12, 2028
Study CompletionOct 1, 2030
TodayJul 1, 2026
Enrollment to primary: 6.4 yearsPosted 4.4 years agoPrimary completion in 2.0 years

Arms & Interventions

Arm A: Durvalumab + Domvanalimabexperimental

Durvalumab and domvanalimab as an IV infusion q4w, starting on Day 1 for up to a maximum of 12 months

Drug: DurvalumabDrug: Domvanalimab
Arm B: Durvalumab + Placeboactive_comparator

Durvalumab + placebo as an IV infusion q4w starting on Day 1 for up to a maximum of 12 months

Drug: DurvalumabOther: Placebo

Interventions

Durvalumabdrug

Durvalumab IV (Intravenous infusion)

Domvanalimabdrug

Domvanalimab IV (Intravenous infusion)

Placeboother

Placebo IV (Intravenous infusion)