Spots Global Cancer Trial Database for Phase III Study to Determine Efficacy of Durvalumab in Stage II-III Non-small Cell Lung Cancer (NSCLC) After Curative Intent Therapy.
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Trial Identification
Brief Title: Phase III Study to Determine Efficacy of Durvalumab in Stage II-III Non-small Cell Lung Cancer (NSCLC) After Curative Intent Therapy.
Official Title: A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Study of Durvalumab for the Treatment of Stage II-III NSCLC Patients With Minimal Residual Disease Following Surgery and Curative Intent Therapy.
Study ID: NCT04642469
Conditions
Study Description
Brief 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.
Detailed 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 surveillance period.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Long Beach, California, United States
Research Site, Los Angeles, California, United States
Research Site, Daytona Beach, Florida, United States
Research Site, Gainesville, Florida, United States
Research Site, Punta Gorda, Florida, United States
Research Site, Louisville, Kentucky, United States
Research Site, Minneapolis, Minnesota, United States
Research Site, Spartanburg, South Carolina, United States
Research Site, Nashville, Tennessee, United States
Research Site, Salt Lake City, Utah, United States
Research Site, Buenos Aires, , Argentina
Research Site, Camperdown, , Australia
Research Site, Melbourne, , Australia
Research Site, St Leonards, , Australia
Research Site, Hasselt, , Belgium
Research Site, Roeselare, , Belgium
Research Site, Barretos, , Brazil
Research Site, Florianópolis, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, São José do Rio Preto, , Brazil
Research Site, Vitoria, , Brazil
Research Site, Victoria, British Columbia, Canada
Research Site, Saint John, New Brunswick, Canada
Research Site, Kingston, Ontario, Canada
Research Site, Ottawa, Ontario, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Olomouc, , Czechia
Research Site, Ostrava, , Czechia
Research Site, Praha 2, , Czechia
Research Site, Marseille, , France
Research Site, Pessac, , France
Research Site, St Herblain, , France
Research Site, Strasbourg Cedex, , France
Research Site, Athens, , Greece
Research Site, Athens, , Greece
Research Site, Heraklion, , Greece
Research Site, Holargos, Athens, , Greece
Research Site, Larissa, , Greece
Research Site, Thessaloniki, , Greece
Research Site, Hong Kong, , Hong Kong
Research Site, Jordan, , Hong Kong
Research Site, Budapest, , Hungary
Research Site, Budapest, , Hungary
Research Site, Gyöngyös - Mátraháza, , Hungary
Research Site, Győr, , Hungary
Research Site, Szolnok, , Hungary
Research Site, Székesfehérvár, , Hungary
Research Site, Törökbálint, , Hungary
Research Site, Bengaluru, , India
Research Site, New Delhi, , India
Research Site, Haifa, , Israel
Research Site, Jerusalem, , Israel
Research Site, Kfar Saba, , Israel
Research Site, Petah Tikva, , Israel
Research Site, Ramat-Gan, , Israel
Research Site, Meldola, , Italy
Research Site, Milano, , Italy
Research Site, Monza, , Italy
Research Site, Orbassano, , Italy
Research Site, Roma, , Italy
Research Site, Rozzano, , Italy
Research Site, Bunkyo-ku, , Japan
Research Site, Hiroshima-shi, , Japan
Research Site, Kashiwa, , Japan
Research Site, Koto-ku, , Japan
Research Site, Osaka-shi, , Japan
Research Site, Osaka-shi, , Japan
Research Site, Sakai-shi, , Japan
Research Site, Sendai-shi, , Japan
Research Site, Sunto-gun, , Japan
Research Site, Yokohama-shi, , Japan
Research Site, Cheongju-si, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Suwon, , Korea, Republic of
Research Site, Breda, , Netherlands
Research Site, Maastricht, , Netherlands
Research Site, Zwolle, , Netherlands
Research Site, Lima, , Peru
Research Site, Lima, , Peru
Research Site, Bydgoszcz, , Poland
Research Site, Gdańsk, , Poland
Research Site, Tomaszów Mazowiecki, , Poland
Research Site, Warszawa, , Poland
Research Site, Moscow, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Novosibirsk, , Russian Federation
Research Site, Saint Petersburg, , Russian Federation
Research Site, Saint Petersburg, , Russian Federation
Research Site, Singapore, , Singapore
Research Site, Singapore, , Singapore
Research Site, Singapore, , Singapore
Research Site, Barcelona, , Spain
Research Site, Barcelona, , Spain
Research Site, Madrid, , Spain
Research Site, Málaga, , Spain
Research Site, Oviedo, , Spain
Research Site, Pamplona, , Spain
Research Site, Santiago de Compostela, , Spain
Research Site, Chiayi, , Taiwan
Research Site, Kaohsiung, , Taiwan
Research Site, Taichung, , Taiwan
Research Site, Tainan, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Tao-Yuan, , Taiwan
Research Site, Adana, , Turkey
Research Site, Ankara, , Turkey
Research Site, Istanbul, , Turkey
Research Site, Istanbul, , Turkey
Research Site, Malatya, , Turkey
Research Site, Hanoi, , Vietnam
Research Site, Ho Chi Minh, , Vietnam
Research Site, Hochiminh, , Vietnam
Contact Details
Name: David Spigel
Affiliation: SCRI Development Innovations, LLC
Role: PRINCIPAL_INVESTIGATOR
Name: Charles Swanton
Affiliation: Francis Crick Institute
Role: PRINCIPAL_INVESTIGATOR
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