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Набира участници Фаза 3 NCT05211895

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

Фаза 3 – широко изпитване преди одобрение
Заболявания: Non-Small Cell Lung Cancer

Спонсор: AstraZeneca

Налично на: БГ
Обобщение
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.
Кой може да участва
INCLUSION CRITERIA: 1. Participant must be ≥ 18 years at the time of screening. 2. Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease 3. Provision of a tumour tissue sample obtained prior to CRT 4. Documented tumour PD-L1 status ≥ 1% by central lab 5. Documented EGFR and ALK wild-type status (local or central). 6. Patients must not have progressed following definitive, platinum-based, concurrent chemoradiotherapy 7. Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy 8. 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. 9. WHO performance status of 0 or 1 at randomization 10. Adequate organ and marrow function EXCLUSION CRITERIA: 1. History of another primary malignancy, except for: * Malignancies treated with curative intent and adequate follow-up with no known active disease and have not required active treatment within the past 3 years before the first dose of study intervention and of low potential risk of recurrence. * Adequately resected non melanoma skin cancer or lentigo maligna without evidence of disease . * Adequately treated carcinoma in situ, including Ta tumors without evidence of disease. 2. Mixed small cell and non-small cell lung cancer histology. 3. Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC. 4. Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT. 5. Any unresolved toxicity CTCAE \>Grade 2 from the prior chemoradiation therapy (excluding alopecia). 6. Participants with ≥ grade 2 pneumonitis from prior chemoradiation therapy. 7. History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or idiopathic pneumonitis - regardless of time of onset prior to randomisation. Evidence of active non-CRT induced pneumonitis (≥ Grade 2), active pneumonia, active ILD, active or recently treated pleural effusion, or current pulmonary fibrosis 8. Active or prior documented autoimmune or inflammatory disorders (with exceptions) 9. Active EBV infection, or known or suspected chronic active EBV infection at screening 10. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
Интервенции
Durvalumab
DRUG
Domvanalimab
DRUG
Placebo
OTHER
Места на провеждане 264
Белгия (6)
Research Site
Brussels
Research Site
Edegem
Research Site
Haine-Saint-Paul
Research Site
Leuven
Research Site
Liège
Research Site
Sint-Niklaas
Бразилия (11)
Research Site
Barretos
ACTIVE_NOT_RECRUITING
Research Site
Londrina
Research Site
Porto Alegre
Research Site
Porto Velho
ACTIVE_NOT_RECRUITING
Research Site
Rio de Janeiro
Research Site
Santo André
ACTIVE_NOT_RECRUITING
Research Site
São Paulo
Research Site
São Paulo
WITHDRAWN
Research Site
São Paulo
WITHDRAWN
Research Site
São Paulo
WITHDRAWN
Research Site
Taubaté
ACTIVE_NOT_RECRUITING
Канада (4)
Research Site
Calgary , Alberta
Research Site
Kelowna , British Columbia
Research Site
Laval , Quebec
Research Site
Montreal , Quebec
Chile (7)
Research Site
Las Condes
Research Site
Port Montt
Research Site
Santiago
Research Site
Santiago
Research Site
Santiago
Research Site
Santiago
Research Site
Temuco
Франция (12)
Research Site
Aix-en-Provence
Research Site
Angers
Research Site
Bobigny
Research Site
Clermont-Ferrand
WITHDRAWN
Research Site
Lille
Research Site
Paris
Research Site
Pau
Research Site
Quimper
Research Site
Saint-Grégoire
Research Site
Saint-Quentin
Research Site
Vantoux
Research Site
Villeurbanne
Германия (20)
Research Site
Berlin
Research Site
Berlin-Zehlendorf
Research Site
Braunschweig
Research Site
Chemnitz
Research Site
Cologne
Research Site
Erlangen
Research Site
Essen
Research Site
Georgsmarienhütte
WITHDRAWN
Research Site
Giessen
Research Site
Halle
Research Site
Hamburg
WITHDRAWN
Research Site
Homburg
WITHDRAWN
Research Site
Koblenz
Research Site
Krefeld
Research Site
Löwenstein
Research Site
Moers
TERMINATED
Research Site
München
WITHDRAWN
Research Site
Regensburg
Research Site
Regensburg
Research Site
Tübingen
Гърция (8)
Research Site
Athens
Research Site
Athens
Research Site
Athens
Research Site
Athens
Research Site
Holargos, Athens
Research Site
Thessaloniki
Research Site
Thessaloniki
Research Site
Thessaloniki
Hong Kong (1)
Research Site
Hong Kong
Унгария (7)
Research Site
Budapest
Research Site
Budapest
Research Site
Deszk
Research Site
Győr
Research Site
Salgótarján
Research Site
Székesfehérvár
Research Site
Törökbálint
Индия (16)
Research Site
Ahmedabad
COMPLETED
Research Site
Bangalore
Research Site
Bangalore
Research Site
Delhi
Research Site
Gurgaon
WITHDRAWN
Research Site
Howrah
Research Site
Hyderabad
Research Site
Jaipur
Research Site
Jaipur
Research Site
Kolkata
Research Site
Marg Jaipur
Research Site
Mohali
COMPLETED
Research Site
Namakkal
Research Site
New Delhi
COMPLETED
Research Site
New Delhi
Research Site
Varanasi
Италия (4)
Research Site
Bergamo
Research Site
Roma
Research Site
Rozzano
Research Site
Udine
WITHDRAWN
Япония (20)
Research Site
Bunkyō City
Research Site
Bunkyō City
Research Site
Bunkyō City
Research Site
Chiba
Research Site
Fukuoka
Research Site
Hidaka-shi
Research Site
Hirosaki-shi
Research Site
Itabashi-ku
Research Site
Kashihara-shi
Research Site
Kōtoku
Research Site
Kumamoto
Research Site
Matsuyama
Research Site
Nagoya
Research Site
Osaka
Research Site
Osakasayama-shi
Research Site
Sapporo
Research Site
Sunto-gun
Research Site
Tokyo
Research Site
Yokohama
Research Site
Yokohama
Malaysia (4)
Research Site
Johor Bahru
Research Site
Kuala Lumpur
Research Site
Kuala Selangor
Research Site
Kuching
Mexico (10)
Research Site
Aguascalientes
WITHDRAWN
Research Site
Chihuahua City
Research Site
Guadalajara
WITHDRAWN
Research Site
Guadalajara
Research Site
Mexico City
Research Site
Monterrey
WITHDRAWN
Research Site
Oaxaca City
Research Site
San Pedro Garza García
WITHDRAWN
Research Site
Sonora
WITHDRAWN
Research Site
Veracruz
WITHDRAWN
Норвегия (4)
Research Site
Bodø
Research Site
Gjøvik
Research Site
Oslo
Research Site
Trondheim
Philippines (7)
Research Site
Bacolod
WITHDRAWN
Research Site
City of Muntinlupa
Research Site
Iloilo City
Research Site
Manila
NOT_YET_RECRUITING
Research Site
Pasig
WITHDRAWN
Research Site
Quezon City
Research Site
Quezon City
Полша (8)
Research Site
Bialystok
Research Site
Gliwice
WITHDRAWN
Research Site
Gliwice
Research Site
Katowice
COMPLETED
Research Site
Lodz
Research Site
Warsaw
Research Site
Wroclaw
Research Site
Zielona Góra
WITHDRAWN
Румъния (9)
Research Site
Bucharest
COMPLETED
Research Site
Bucharest
COMPLETED
Research Site
Craiova
Research Site
Floreşti
Research Site
Iași
Research Site
Oradea
Research Site
Sibiu
Research Site
Suceava
COMPLETED
Research Site
Timișoara
WITHDRAWN
South Africa (6)
Research Site
Cape Town
WITHDRAWN
Research Site
eManzimtoti
WITHDRAWN
Research Site
eManzimtoti
COMPLETED
Research Site
Johannesburg
WITHDRAWN
Research Site
Parktown
TERMINATED
Research Site
Pretoria
ACTIVE_NOT_RECRUITING
Южна Корея (11)
Research Site
Daegu
Research Site
Goyang-si
Research Site
Incheon
Research Site
Incheon
Research Site
Jinju
Research Site
Seoul
WITHDRAWN
Research Site
Seoul
Research Site
Seoul
Research Site
Seoul
Research Site
Seoul
Research Site
Suwon
Испания (6)
Research Site
Bilbao (Vizcaya)
Research Site
Castellon
Research Site
Córdoba
Research Site
El Palmar
Research Site
Palma de Mallorca
Research Site
Sabadell (Barcelona)
Швейцария (3)
Research Site
Basel
Research Site
Bern
Research Site
Lausanne
Taiwan (9)
Research Site
Hsinchu
Research Site
New Taipei City
Research Site
Taichung
Research Site
Taichung
Research Site
Tainan
Research Site
Taipei
Research Site
Taipei
Research Site
Taipei
Research Site
Taoyuan District
Тайланд (4)
Research Site
Bangkok
Research Site
Bangkok
Research Site
Bangkok
Research Site
Hat Yai
Турция (10)
Research Site
Adapazarı
Research Site
Ankara
Research Site
Ankara
Research Site
Antalya
Research Site
Çankaya
Research Site
Edirne
Research Site
Istanbul
Research Site
Istanbul
Research Site
Izmir
Research Site
Konya
Великобритания (11)
Research Site
Birmingham
Research Site
Brighton
Research Site
Cambridge
WITHDRAWN
Research Site
Cardiff
Research Site
Cheltenham
Research Site
Edinburgh
Research Site
High Heaton/Newcastle Upon Tyn
Research Site
Leeds
Research Site
London
Research Site
Nottingham
Research Site
Truro
САЩ (43)
Research Site
Ann Arbor , Michigan
Research Site
Appleton , Wisconsin
Research Site
Arlington , Virginia
Research Site
Asheville , North Carolina
WITHDRAWN
Research Site
Asheville , North Carolina
WITHDRAWN
Research Site
Baltimore , Maryland
Research Site
Buffalo , New York
WITHDRAWN
Research Site
Chandler , Arizona
Research Site
Charleston , South Carolina
SUSPENDED
Research Site
Charlotte , North Carolina
WITHDRAWN
Research Site
Chattanooga , Tennessee
Research Site
Columbus , Ohio
Research Site
Columbus , Ohio
WITHDRAWN
Research Site
Detroit , Michigan
COMPLETED
Research Site
East Brunswick , New Jersey
Research Site
Elmhurst , Illinois
SUSPENDED
Research Site
Florham Park , New Jersey
WITHDRAWN
Research Site
Fort Belvoir , Virginia
Research Site
Fort Sam Houston , Texas
Research Site
Fountain Valley , California
Research Site
Jacksonville , Florida
SUSPENDED
Research Site
Johnson City , New York
WITHDRAWN
Research Site
Kingwood , Texas
WITHDRAWN
Research Site
Louisville , Kentucky
SUSPENDED
Research Site
Macon , Georgia
SUSPENDED
Research Site
Maumee , Ohio
Research Site
Maywood , Illinois
WITHDRAWN
Research Site
Minneapolis , Minnesota
Research Site
Naperville , Illinois
WITHDRAWN
Research Site
Nashville , Tennessee
Research Site
Nashville , Tennessee
SUSPENDED
Research Site
Oklahoma City , Oklahoma
Research Site
Orlando , Florida
Research Site
Phoenix , Arizona
SUSPENDED
Research Site
Pittsburgh , Pennsylvania
Research Site
Reno , Nevada
Research Site
Rochester , Minnesota
SUSPENDED
Research Site
Saint Augustine , Florida
Research Site
Santa Rosa , California
Research Site
Silver Spring , Maryland
SUSPENDED
Research Site
Spokane Valley , Washington
Research Site
Washington D.C. , District of Columbia
Research Site
Winston-Salem , North Carolina
WITHDRAWN
Vietnam (3)
Research Site
Hanoi
Research Site
Hanoi
Research Site
Ho Chi Minh City
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
18.02.2022
Крайна дата
01.10.2030
Регистрационен номер
NCT05211895
Източник
clinicaltrials.gov
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