Lung Cancer Clinical Trial
Phase III Study to Determine Efficacy of Durvalumab in Stage II-III Non-small Cell Lung Cancer (NSCLC) After Curative Intent Therapy.
Summary
This is a Phase III double-blind, placebo-controlled study of Durvalumab versus Placebo in patients with stage II-III NSCLC who are MRD-positive following curative intent therapy.
Full Description
This is a Phase III, randomized, multicenter, double-blind, placebo-controlled, study to evaluate the efficacy and safety of durvalumab adjuvant therapy compared to placebo in patients with completely resected stage II-III NSCLC who have undergone curative intent therapy (complete resection ± neoadjuvant and/or adjuvant therapy), who have no evidence of Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1-defined disease recurrence, and who become MRD+ during a 96-week surveillance period.
Eligibility Criteria
Inclusion Criteria:
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICFs and in the protocol.
Age ≥18 years at the time of screening (ICF1);
Histologically confirmed NSCLC with resectable stage II-III disease
Complete resection of the primary NSCLC
Exclusion Criteria:
EGFR and/or ALK mutant
Mixed small cell and NSCLC histology
History of allogeneic organ or bone marrow transplantation
History of active primary immunodeficiency
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There are 113 Locations for this study
Long Beach California, 90806, United States
Los Angeles California, 90089, United States
Daytona Beach Florida, 32117, United States
Gainesville Florida, 32605, United States
Punta Gorda Florida, 33980, United States
Louisville Kentucky, 40241, United States
Minneapolis Minnesota, 55404, United States
Spartanburg South Carolina, 29303, United States
Nashville Tennessee, 37203, United States
Salt Lake City Utah, 84112, United States
Ciudad Autonoma De Buenos Aire , C1125, Argentina
Camperdown , 2050, Australia
Melbourne , 3000, Australia
St Leonards , 2065, Australia
Hasselt , 3500, Belgium
Roeselare , 8800, Belgium
Barretos , 14784, Brazil
Florianópolis , 88034, Brazil
Porto Alegre , 90610, Brazil
Vitoria , 29043, Brazil
Victoria British Columbia, V8R 6, Canada
Saint John New Brunswick, E2L 4, Canada
Kingston Ontario, K7L 2, Canada
Ottawa Ontario, K1H 8, Canada
Montreal Quebec, H4A 3, Canada
Olomouc , 77900, Czechia
Ostrava , 703 0, Czechia
Praha 2 , 128 0, Czechia
Marseille , 13915, France
Pessac , 33604, France
St Herblain , 44805, France
Strasbourg Cedex , 67091, France
Athens , 11526, Greece
Athens , 11527, Greece
Heraklion , 711 1, Greece
Holargos, Athens , 155 6, Greece
Larissa , 41110, Greece
Thessaloniki , 54645, Greece
Hong Kong , , Hong Kong
Jordan , , Hong Kong
Budapest , 1083, Hungary
Budapest , 1121, Hungary
Gyöngyös - Mátraháza , 3200, Hungary
Győr , 9024, Hungary
Szolnok , 5004, Hungary
Székesfehérvár , 8000, Hungary
Törökbálint , 2045, Hungary
Bengaluru , 56009, India
New Delhi , 11029, India
Haifa , 31096, Israel
Jerusalem , 91120, Israel
Kfar Saba , 44281, Israel
Petah Tikva , 49100, Israel
Ramat-Gan , 52621, Israel
Meldola , 47014, Italy
Milano , 20133, Italy
Monza , 20052, Italy
Orbassano , 10043, Italy
Roma , 00144, Italy
Rozzano , 20089, Italy
Akashi-shi , 673-8, Japan
Bunkyo-ku , 160-0, Japan
Hiroshima-shi , 734-8, Japan
Kashiwa , 277-8, Japan
Koto-ku , 135-8, Japan
Osaka-shi , 534-0, Japan
Osaka-shi , 541-8, Japan
Sakai-shi , 591-8, Japan
Sendai-shi , 980-0, Japan
Sunto-gun , 411-8, Japan
Yokohama-shi , 241-8, Japan
Cheongju-si , 28644, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Suwon , 16247, Korea, Republic of
Breda , 4818 , Netherlands
Maastricht , 6202 , Netherlands
Zwolle , 8025 , Netherlands
Bellavista , CALLA, Peru
Lima , 0051, Peru
Lima , Lima , Peru
Lima , LIMA , Peru
Bydgoszcz , 85-79, Poland
Gdańsk , 80-21, Poland
Tomaszów Mazowiecki , 97-20, Poland
Warszawa , 02-78, Poland
Wrocław , 53-41, Poland
Moscow , 10522, Russian Federation
Moscow , 11547, Russian Federation
Novosibirsk , 63010, Russian Federation
Saint Petersburg , 19103, Russian Federation
Saint Petersburg , 19775, Russian Federation
Singapore , 11922, Singapore
Singapore , 16961, Singapore
Singapore , 30843, Singapore
Barcelona , 08035, Spain
Barcelona , 08041, Spain
Madrid , 28041, Spain
Málaga , 29010, Spain
Oviedo , 33011, Spain
Pamplona , 31008, Spain
Santiago de Compostela , 15706, Spain
Chiayi , 613, Taiwan
Kaohsiung , , Taiwan
Taichung , 40201, Taiwan
Tainan , 70403, Taiwan
Taipei , 11217, Taiwan
Taipei , 235, Taiwan
Tao-Yuan , 333, Taiwan
Adana , 01120, Turkey
Ankara , 06010, Turkey
Istanbul , 34010, Turkey
Istanbul , 34214, Turkey
Malatya , 44280, Turkey
Hanoi , 10000, Vietnam
Ho Chi Minh , 70000, Vietnam
Hochiminh , 70000, Vietnam
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