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
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 IV (Intravenous infusion)
- DRUG
-
Domvanalimab
Domvanalimab IV (Intravenous infusion)
- OTHER
-
Placebo
Placebo IV (Intravenous infusion)
Sponsors & Collaborators
-
Arcus Biosciences, Inc.
collaborator INDUSTRY - 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
-
Chemoradiation Plus Durvalumab Followed by Surgery Followed by Adjuvant Durvalumab in Patients With Surgically Resectable Stage III (N2) Non-Small Cell Lung Cancer
NCT03871153 ·Status: TERMINATED ·Phase: PHASE2
-
Phase III Study to Determine Efficacy of Durvalumab in Stage II-III Non-small Cell Lung Cancer (NSCLC) After Curative Intent Therapy.
NCT04642469 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Durvalumab Following Radiation Therapy in Patients With Stage 3 Unresectable NSCLC Ineligible for Chemotherapy
NCT04249362 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Determine Safety of Durvalumab After Sequential Chemo Radiation in Patients With Unresectable Stage III Non-Small Cell Lung Cancer
NCT03693300 ·Status: COMPLETED ·Phase: PHASE2
-
Study Evaluating Effectiveness and Safety of Zimberelimab and Domvanalimab in Lung Cancer
NCT04736173 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Real World Evidence of Long-term Safety and Efficacy in Patients Treated With Durvalumab After Concurrent Chemoradiation for Unresectable Stage III NSCLC
NCT03995875 ·Status: COMPLETED
-
A Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer
NCT02352948 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE)
NCT02542293 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer
NCT02125461 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Participants With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC)
NCT04513925 ·Status: COMPLETED ·Phase: PHASE3
-
Survival Study of Docetaxel and Carboplatin as Neo-Adjuvant Vs Adjuvant Chemotherapy in Early Stage NSLC
NCT00321334 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Assess Neoadjuvant Durvalumab (D) and Platinum-Based Chemotherapy (CT), Followed by Either Surgery and Adjuvant D or CRT and Consolidation D, in Resectable or Borderline Resectable Stage IIB-IIIB NSCLC (MDT-BRIDGE)
NCT05925530 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Randomized Trial Comparing Standard of Care Versus Immune- Based Combination in Relapsed Stage III Non-small-cell Lung Cancer (NSCLC) Pretreated With Chemoradiotherapy and Durvalumab
NCT05568212 ·Status: RECRUITING ·Phase: PHASE2
-
Intensified Chemo-immuno-radiotherapy With Durvalumab for Stage III Non-Small Cell Lung Cancers
NCT04230408 ·Status: COMPLETED ·Phase: PHASE2
-
Phase III Study to Determine the Efficacy of Durvalumab in Combination With Chemotherapy in Completely Resected Stage II-III Non-small Cell Lung Cancer (NSCLC)
NCT04385368 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer
NCT03800134 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Study of Durvalumab Alone or Chemotherapy for Patients With Advanced Non Small-Cell Lung Cancer (PEARL)
NCT03003962 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC
NCT03822351 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase III Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Non Small Cell Lung Cancer (NSCLC) Whose Disease Progressed On or After Prior Anti PD (L)1 Therapy And Platinum Based Chemotherapy
NCT05450692 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Durvalumab (MEDI4736) With or Without SBRT in Clinical Stage I, II and IIIA Non-small Cell Lung Cancer
NCT02904954 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Compare Ociperlimab Plus Tislelizumab Versus Durvalumab Following Concurrent Chemoradiotherapy (cCRT) in Participants With Stage III Unresectable Non-Small Cell Lung Cancer
NCT04866017 ·Status: TERMINATED ·Phase: PHASE3
-
Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy
NCT03703297 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study of Onartuzumab (MetMAb) Versus Placebo in Combination With Paclitaxel Plus Platinum in Patients With Squamous Non-Small Cell Lung Cancer
NCT01519804 ·Status: COMPLETED ·Phase: PHASE2
-
A Trial With Chemotherapy, Immunotherapy, and Radiotherapy for Patients With Newly Diagnosed Stage IV Small Cell Lung Cancer
NCT04951115 ·Status: TERMINATED ·Phase: PHASE2
-
A Study to Investigate Efficacy and Safety of Ceralasertib Plus Durvalumab in Participants Aged ≥ 18 Years With Advanced or Metastatic Non-small Cell Lung Cancer Whose Disease Progressed on or After Prior Anti-PD-(L)1 Therapy and Platinum-based Chemotherapy
NCT05941897 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2