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
Who is this study for? Patients with locally advanced, unresectable NSCLC
What treatments are being studied? Durvalumab+Domvanalimab
Status: Recruiting
Location: See all (260) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participant must be ≥ 18 years at the time of screening.
• Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease
• Provision of a tumour tissue sample obtained prior to CRT
• Documented tumour PD-L1 status ≥ 1% by central lab
• Documented EGFR and ALK wild-type status (local or central).
• Patients must not have progressed following definitive, platinum-based, concurrent chemoradiotherapy
• Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy
• Participants must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66 Gy) as part of the chemoradiation therapy, to be randomised. Radiation therapy should be administered by intensity modulated RT (preferred) or 3D-conforming technique.
• WHO performance status of 0 or 1 at randomization
⁃ Adequate organ and marrow function
Locations
United States
Arizona
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RECRUITING
Chandler
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SUSPENDED
Phoenix
California
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Fountain Valley
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Santa Rosa
Washington, D.c.
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Washington D.c.
Florida
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Jacksonville
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Orlando
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Saint Augustine
Georgia
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Macon
Illinois
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Elmhurst
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Maywood
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Naperville
Kentucky
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Louisville
Maryland
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Baltimore
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Silver Spring
Michigan
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Detroit
Minnesota
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Minneapolis
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Rochester
North Carolina
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Asheville
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Asheville
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Charlotte
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Winston-salem
New Jersey
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East Brunswick
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Florham Park
Nevada
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Reno
New York
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Buffalo
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Johnson City
Ohio
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Columbus
Oklahoma
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Oklahoma City
Pennsylvania
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Pittsburgh
South Carolina
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Charleston
Tennessee
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Chattanooga
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Nashville
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Nashville
Texas
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Fort Sam Houston
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Kingwood
Virginia
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Arlington
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Fort Belvoir
Washington
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Spokane Valley
Wisconsin
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Appleton
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Brussels
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Edegem
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Haine-saint-paul
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Leuven
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Liège
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Sint-niklaas
Brazil
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Barretos
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Londrina
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Porto Alegre
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Porto Velho
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Rio De Janeiro
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Santo André
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São Paulo
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São Paulo
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São Paulo
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São Paulo
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Taubaté
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Las Condes
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Port Montt
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Santiago
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Santiago
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Temuco
France
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Angers
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Bobigny
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Paris
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Pau
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Quimper
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Saint-quentin
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Vantoux
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Villeurbanne
Germany
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Braunschweig
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Chemnitz
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Cologne
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Erlangen
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Essen
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Georgsmarienhütte
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Giessen
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Halle
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Hamburg
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Homburg
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Koblenz
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Krefeld
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Löwenstein
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Moers
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München
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Regensburg
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Regensburg
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Tübingen
Greece
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Athens
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Athens
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Athens
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Athens
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Holargos, Athens
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Ahmedabad
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Bangalore
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Delhi
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Gūrgaon
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Howrah
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Hyderabad
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Jaipur
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Varanasi
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Udine
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Poland
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Warsaw
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Wroclaw
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Zielona Góra
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Daegu
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Jinju
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Seoul
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Seoul
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Seoul
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Seoul
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Suwon
Romania
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Bucharest
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Craiova
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Floreşti
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Iași
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Oradea
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Sibiu
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Timișoara
South Africa
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Cape Town
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Emanzimtoti
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Emanzimtoti
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Parktown
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Pretoria
Spain
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Córdoba
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Palma De Mallorca
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Sabadell (barcelona)
Switzerland
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Basel
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Bern
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Lausanne
Taiwan
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Hsinchu
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New Taipei City
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Taichung
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Taichung
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Tainan City
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Taipei
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Taipei
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Taipei
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Taoyuan District
Thailand
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Bangkok
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Bangkok
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Bangkok
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Hat Yai
Turkey
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Adapazarı
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Ankara
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Ankara
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Antalya
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Çankaya
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Edirne
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Istanbul
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Istanbul
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Izmir
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Konya
United Kingdom
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Birmingham
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Brighton
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Cambridge
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Cardiff
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Cheltenham
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High Heaton/newcastle Upon Tyn
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Leeds
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London
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Nottingham
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NOT_YET_RECRUITING
Truro
Viet Nam
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NOT_YET_RECRUITING
Hanoi
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NOT_YET_RECRUITING
Hanoi
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NOT_YET_RECRUITING
Ho Chi Minh City
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Backup
AstraZeneca Lung Cancer Study Locator Service
az-lcsl@careboxhealth.com
1-884-432-3892
Time Frame
Start Date:2022-02-18
Estimated Completion Date:2030-09-12
Participants
Target number of participants:860
Treatments
Experimental: Arm A: Durvalumab + Domvanalimab
Durvalumab and domvanalimab as an IV infusion q4w, starting on Day 1 for up to a maximum of 12 months
Active_comparator: Arm B: Durvalumab + Placebo
Durvalumab + placebo as an IV infusion q4w starting on Day 1 for up to a maximum of 12 months