Spots Global Cancer Trial Database for Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations
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Trial Identification
Brief Title: Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations
Official Title: A Phase III, Randomised, Open-label, Multicentre, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Durvalumab and Carboplatin Versus Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Locally Advanced or Metastatic NSCLC Without Actionable Genomic Alterations (D926NC00001; AVANZAR)
Study ID: NCT05687266
Conditions
Study Description
Brief Summary: This is a Phase III, randomized, open-label, multicenter, global study to compare the efficacy and safety of Datopotamab Deruxtecan (Dato-DXd) in combination with durvalumab and carboplatin compared with pembrolizumab in combination with histology-specific platinum-based chemotherapy as first-line treatment of adults with stage IIIB, IIIC, or IV NSCLC without actionable genomic alterations (including sensitizing EGFR mutations, and ALK and ROS1 rearrangements).
Detailed Description: Participants with locally advanced or metastatic NSCLC without actionable tumor tissue genomic alterations and confirmed to meet all eligibility criteria will be randomized in a 1:1 ratio to Dato-DXd in combination with durvalumab and carboplatin versus pembrolizumab in combination with histology-specific platinum-based chemotherapy as first-line treatment. The primary objectives of the study are to demonstrate superiority of Dato-DXd in combination with durvalumab and carboplatin relative to pembrolizumab in combination with platinum-based chemotherapy by assessment of Progression Free Survival (PFS) by BICR and Overall Survival (OS) in first-line treatment of TROP2 biomarker positive participants.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Phoenix, Arizona, United States
Research Site, Tucson, Arizona, United States
Research Site, Hot Springs National Park, Arkansas, United States
Research Site, Little Rock, Arkansas, United States
Research Site, Springdale, Arkansas, United States
Research Site, Fountain Valley, California, United States
Research Site, Lakewood, California, United States
Research Site, Los Angeles, California, United States
Research Site, Orange, California, United States
Research Site, Boulder, Colorado, United States
Research Site, Fort Lauderdale, Florida, United States
Research Site, Fort Myers, Florida, United States
Research Site, Jacksonville, Florida, United States
Research Site, Lakeland, Florida, United States
Research Site, Saint Petersburg, Florida, United States
Research Site, West Palm Beach, Florida, United States
Research Site, Evergreen Park, Illinois, United States
Research Site, Quincy, Illinois, United States
Research Site, Fort Wayne, Indiana, United States
Research Site, Muncie, Indiana, United States
Research Site, Bettendorf, Iowa, United States
Research Site, Des Moines, Iowa, United States
Research Site, Iowa City, Iowa, United States
Research Site, Baton Rouge, Louisiana, United States
Research Site, Baton Rouge, Louisiana, United States
Research Site, Covington, Louisiana, United States
Research Site, Duluth, Minnesota, United States
Research Site, Minneapolis, Minnesota, United States
Research Site, Rochester, Minnesota, United States
Research Site, Hannibal, Missouri, United States
Research Site, Lincoln, Nebraska, United States
Research Site, Lincoln, Nebraska, United States
Research Site, Las Vegas, Nevada, United States
Research Site, Clifton Park, New York, United States
Research Site, East Hills, New York, United States
Research Site, East Syracuse, New York, United States
Research Site, West Islip, New York, United States
Research Site, Asheville, North Carolina, United States
Research Site, Winston-Salem, North Carolina, United States
Research Site, Fargo, North Dakota, United States
Research Site, Canton, Ohio, United States
Research Site, Columbus, Ohio, United States
Research Site, Toledo, Ohio, United States
Research Site, Tulsa, Oklahoma, United States
Research Site, Portland, Oregon, United States
Research Site, Salem, Oregon, United States
Research Site, Philadelphia, Pennsylvania, United States
Research Site, Philadelphia, Pennsylvania, United States
Research Site, Philadelphia, Pennsylvania, United States
Research Site, Pittsburgh, Pennsylvania, United States
Research Site, York, Pennsylvania, United States
Research Site, Watertown, South Dakota, United States
Research Site, Knoxville, Tennessee, United States
Research Site, Memphis, Tennessee, United States
Research Site, Nashville, Tennessee, United States
Research Site, Dallas, Texas, United States
Research Site, Dallas, Texas, United States
Research Site, Denton, Texas, United States
Research Site, Fort Worth, Texas, United States
Research Site, Houston, Texas, United States
Research Site, Houston, Texas, United States
Research Site, Irving, Texas, United States
Research Site, San Antonio, Texas, United States
Research Site, Sugar Land, Texas, United States
Research Site, Fairfax, Virginia, United States
Research Site, Fort Belvoir, Virginia, United States
Research Site, Henrico, Virginia, United States
Research Site, Norfolk, Virginia, United States
Research Site, Auburn, Washington, United States
Research Site, Renton, Washington, United States
Research Site, Spokane, Washington, United States
Research Site, Tacoma, Washington, United States
Research Site, Appleton, Wisconsin, United States
Research Site, La Crosse, Wisconsin, United States
Research Site, Graz, , Austria
Research Site, Rankweil, , Austria
Research Site, Wien, , Austria
Research Site, Wien, , Austria
Research Site, Blumenau, , Brazil
Research Site, Florianópolis, , Brazil
Research Site, Fortaleza, , Brazil
Research Site, Londrina, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Sao Paulo, , Brazil
Research Site, Sao Paulo, , Brazil
Research Site, Sao Paulo, , Brazil
Research Site, São Paulo, , Brazil
Research Site, Taubaté, , Brazil
Research Site, Vitoria, , Brazil
Research Site, Panagyurishte, , Bulgaria
Research Site, Plovdiv, , Bulgaria
Research Site, Plovdiv, , Bulgaria
Research Site, Sofia, , Bulgaria
Research Site, Sofia, , Bulgaria
Research Site, Sofia, , Bulgaria
Research Site, Sofia, , Bulgaria
Research Site, Varna, , Bulgaria
Research Site, Saint John, New Brunswick, Canada
Research Site, Brampton, Ontario, Canada
Research Site, Kitchener, Ontario, Canada
Research Site, Newmarket, Ontario, Canada
Research Site, Sudbury, Ontario, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Montreal, Quebec, Canada
Research Site, St-Jerome, Quebec, Canada
Research Site, Saskatoon, Saskatchewan, Canada
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Changsha, , China
Research Site, Changsha, , China
Research Site, Chengdu, , China
Research Site, Chengdu, , China
Research Site, Chongqing, , China
Research Site, Guangzhou, , China
Research Site, Guangzhou, , China
Research Site, Hefei, , China
Research Site, Jinan, , China
Research Site, Kunming, , China
Research Site, Kunming, , China
Research Site, Lanzhou, , China
Research Site, Liuzhou, , China
Research Site, Shandong, , China
Research Site, Shanghai, , China
Research Site, Shanghai, , China
Research Site, Shanghai, , China
Research Site, Shantou, , China
Research Site, Shenyang, , China
Research Site, Shenzhen, , China
Research Site, Shijiazhuang, , China
Research Site, Taiyuan, , China
Research Site, Tianjin, , China
Research Site, Wenzhou, , China
Research Site, Wuhan, , China
Research Site, Wuhan, , China
Research Site, Xiamen, , China
Research Site, Yangzhou, , China
Research Site, Zhengzhou, , China
Research Site, Herning, , Denmark
Research Site, Næstved, , Denmark
Research Site, Sønderborg, , Denmark
Research Site, Brest, , France
Research Site, Clermont-Ferrand, , France
Research Site, Creteil, , France
Research Site, Gleize, , France
Research Site, Montpellier, , France
Research Site, Nimes, , France
Research Site, Paris CEDEX 14, , France
Research Site, Paris, , France
Research Site, Rouen, , France
Research Site, Saint-Quentin cedex, , France
Research Site, Strasbourg Cedex, , France
Research Site, Toulon Cedex 9, , France
Research Site, Toulouse, , France
Research Site, Tours, , France
Research Site, Bad Berka, , Germany
Research Site, Berlin, , Germany
Research Site, Berlin, , Germany
Research Site, Frankfurt A. Main, , Germany
Research Site, Gauting, , Germany
Research Site, Gütersloh, , Germany
Research Site, Hamburg, , Germany
Research Site, Kassel, , Germany
Research Site, Kiel, , Germany
Research Site, Koblenz, , Germany
Research Site, Minden, , Germany
Research Site, Mönchengladbach, , Germany
Research Site, Paderborn, , Germany
Research Site, Rosenheim, , Germany
Research Site, Velbert, , Germany
Research Site, Würzburg, , Germany
Research Site, Athens, , Greece
Research Site, Athens, , Greece
Research Site, Athens, , Greece
Research Site, Peiraias, , Greece
Research Site, Thessaloniki, , Greece
Research Site, Thessaloniki, , Greece
Research Site, Budapest, , Hungary
Research Site, Budapest, , Hungary
Research Site, Gyöngyös - Mátraháza, , Hungary
Research Site, Kaposvár, , Hungary
Research Site, Pécs, , Hungary
Research Site, Szekszárd, , Hungary
Research Site, Szolnok, , Hungary
Research Site, Törökbálint, , Hungary
Research Site, Calicut, , India
Research Site, Delhi, , India
Research Site, Delhi, , India
Research Site, Jaipur, , India
Research Site, Kolkata, , India
Research Site, Madurai, , India
Research Site, New Delhi, , India
Research Site, Puducherry, , India
Research Site, Firenze, , Italy
Research Site, Lecco, , Italy
Research Site, Messina, , Italy
Research Site, Napoli, , Italy
Research Site, Orbassano, , Italy
Research Site, Padova, , Italy
Research Site, Parma, , Italy
Research Site, Peschiera Del Garda, , Italy
Research Site, Rozzano, , Italy
Research Site, Bunkyo-ku, , Japan
Research Site, Chuo-ku, , Japan
Research Site, Hamamatsu-shi, , Japan
Research Site, Hamamatsu-shi, , Japan
Research Site, Hidaka-shi, , Japan
Research Site, Himeji-shi, , Japan
Research Site, Hirosaki-shi, , Japan
Research Site, Hiroshima-shi, , Japan
Research Site, Kumamoto-shi, , Japan
Research Site, Morioka-shi, , Japan
Research Site, Nagoya-shi, , Japan
Research Site, Nagoya-shi, , Japan
Research Site, Natori-shi, , Japan
Research Site, Okayama-shi, , Japan
Research Site, Osaka-shi, , Japan
Research Site, Osakasayama-shi, , Japan
Research Site, Sapporo-shi, , Japan
Research Site, Sunto-gun, , Japan
Research Site, Wakayama-shi, , Japan
Research Site, Yokohama-shi, , Japan
Research Site, Yokohama-shi, , Japan
Research Site, Busan, , Korea, Republic of
Research Site, Cheongju-si, , Korea, Republic of
Research Site, Jinju-si, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Suwon-si, , Korea, Republic of
Research Site, Suwon, , Korea, Republic of
Research Site, Cdmx, , Mexico
Research Site, Del. Cuauhtemoc, , Mexico
Research Site, Merida, , Mexico
Research Site, Mexico, , Mexico
Research Site, Mexico, , Mexico
Research Site, San Luis Potosí, , Mexico
Research Site, Arequipa, , Peru
Research Site, Concepción, , Peru
Research Site, Lima, , Peru
Research Site, Lima, , Peru
Research Site, Lima, , Peru
Research Site, Lima, , Peru
Research Site, Bydgoszcz, , Poland
Research Site, Bystra, , Poland
Research Site, Grudziądz, , Poland
Research Site, Kielce, , Poland
Research Site, Koszalin, , Poland
Research Site, Olsztyn, , Poland
Research Site, Piła, , Poland
Research Site, Poznań, , Poland
Research Site, Przemysl, , Poland
Research Site, Racibórz, , Poland
Research Site, Radom, , Poland
Research Site, Siedlce, , Poland
Research Site, Tomaszów Mazowiecki, , Poland
Research Site, Wroclaw, , Poland
Research Site, Girona, , Spain
Research Site, Las Palmas de Gran Canaria, , Spain
Research Site, Lugo, , Spain
Research Site, Madrid, , Spain
Research Site, Santander, , Spain
Research Site, Sevilla, , Spain
Research Site, Valencia, , Spain
Research Site, Zaragoza, , Spain
Research Site, Gävle, , Sweden
Research Site, Linköping, , Sweden
Research Site, Lund, , Sweden
Research Site, Stockholm, , Sweden
Research Site, Uppsala, , Sweden
Research Site, Hsinchu, , Taiwan
Research Site, Taichung, , Taiwan
Research Site, Taipei City, , Taiwan
Research Site, Taipei City, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taoyuan City, , Taiwan
Research Site, Yung Kang City, , Taiwan
Research Site, Adana, , Turkey
Research Site, Ankara, , Turkey
Research Site, Edirne, , Turkey
Research Site, Istanbul, , Turkey
Research Site, Izmir, , Turkey
Research Site, Aberdeen, , United Kingdom
Research Site, Cambridge, , United Kingdom
Research Site, Cardiff, , United Kingdom
Research Site, Cheltenham, , United Kingdom
Research Site, Edinburgh, , United Kingdom
Research Site, Leicester, , United Kingdom
Research Site, London, , United Kingdom
Research Site, London, , United Kingdom
Research Site, Manchester, , United Kingdom
Research Site, Middlesborough, , United Kingdom
Research Site, Newcastle-Upon-Tyne, , United Kingdom
Research Site, Taunton, , United Kingdom
Research Site, Torquay, , United Kingdom
Research Site, Hanoi, , Vietnam
Research Site, Ho Chi Minh city, , Vietnam
Research Site, Ho Chi Minh, , Vietnam
Contact Details
Name: Charu Aggarwal
Affiliation: Perelman Center for Advanced Medicine
Role: STUDY_CHAIR
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