Spots Global Cancer Trial Database for Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations
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Trial Identification
Brief Title: Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations
Official Title: A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-naïve Subjects With Advanced or Metastatic PD-L1 High (TPS ≥50%) Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung08)
Study ID: NCT05215340
Conditions
Study Description
Brief Summary: This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab alone in participants with advanced or metastatic non-small cell lung cancer (NSCLC).
Detailed Description: The primary objective of the study is to compare the efficacy of Dato-DXd and pembrolizumab with pembrolizumab alone in terms of either Progression Free Survival (PFS) or Overall Survival (OS) for participants with advanced or metastatic NSCLC without actionable genomic alterations whose tumor has high programmed death-ligand 1 (PD-L1) expression (tumor proportion score; TPS ≥50%) and who have not previously received systemic therapy for advanced or metastatic NSCLC. Eligible participants will be randomized in a 1:1 ratio to the control arm (pembrolizumab alone) or the experimental arm (Dato-DXd and pembrolizumab). The study will be divided into 4 periods: Tissue Screening Period, Screening Period, Treatment Period, and Follow-up Period.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Ironwood Cancer and Research Center, Chandler, Arizona, United States
UCLA HemOnc - Clinical Research Unit, Los Angeles, California, United States
Compassionate Cancer Care Medical Group, Riverside, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
Ridley-Tree Cancer Center, Santa Barbara, California, United States
PIH Health Whittier Hospital, Whittier, California, United States
The Oncology Institute of Hope and Innovation, Whittier, California, United States
Uch-Mhs D/B/A Memorial Health System, Colorado Springs, Colorado, United States
Johns Hopkins University, Baltimore, Maryland, United States
American Oncology Partners of Maryland, Bethesda, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
DFCI - Steward St. Elizabeth's Medical Center, Boston, Massachusetts, United States
Dana Farber Cancer Institute - Foxborough, Foxboro, Massachusetts, United States
Dana Farber Cancer Institute - Milford Medical Center, Milford, Massachusetts, United States
DFCI - South Shore Hospital, South Weymouth, Massachusetts, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
Astera Cancer Care, East Brunswick, New Jersey, United States
Regional Cancer Care Associates LLC, Freehold, New Jersey, United States
Cooperman Barnabas Medical Center, New Brunswick, New Jersey, United States
The Valley Hospital, Paramus, New Jersey, United States
Montefiore Medical Center, Bronx, New York, United States
Arizona Oncology NAHOA, Irving, Texas, United States
Cancer Care Center of Brevard, Irving, Texas, United States
Illinois Cancer Specialists, Irving, Texas, United States
Maryland Oncology Hematology, Irving, Texas, United States
Southern Cancer Center, Irving, Texas, United States
Texas Oncology - Northeast Texas, Irving, Texas, United States
Texas Oncology Gulf Coast, Irving, Texas, United States
Texas Oncology McAllen, Irving, Texas, United States
Woodlands Medical, Irving, Texas, United States
University of Texas Health Science Center San Antonio, San Antonio, Texas, United States
Utah Cancer Specialists, Salt Lake City, Utah, United States
Providence Regional Cancer System, Lacey, Washington, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Fundacion CENIT para la investigación en Neurociencias, Ciudad Autonoma de Buenos Aire, , Argentina
Hospital Privado de la Comunidad, Mar del Plata, , Argentina
Centro de Investigación Pergamino S. A., Pergamino, , Argentina
Instituto de Oncología de Rosario, Rosario, , Argentina
Sanatorio Parque, Rosario, , Argentina
Sanatorio Británico de Rosario, Rosario, , Argentina
CER SAN JUAN - Centro Polivalente de Asistencia e Investigación Clínica, San Juan, , Argentina
Clinica Viedma SA, Viedma, , Argentina
Austin Hospital, Heidelberg, Victoria, Australia
Peninsula and South Eastern Haematology and Oncology Group, Mount Waverley, Victoria, Australia
Chris Obrien Lifehouse, Camperdown, , Australia
The Queen Elizabeth Hospital, Woodville South, , Australia
Klinikum Klagenfurt am Wörthersee Abteilung für Lungenkrankheiten, Klagenfurt, , Austria
Karl-Landsteiner Institute for Lung Research and Pulmonary Oncology c/o Klinik Floridsdorf, Vienna, , Austria
Onze-Lieve-Vrouwziekenhuis Olvz - Campus Aalst, Aalst, , Belgium
Grand Hopital de Charleroi - Hopital Saint Joseph, Charleroi, , Belgium
Az Maria Middelares - Campus Maria Middelares, Gent, , Belgium
AZ Nikolaas, Sint-Niklaas, , Belgium
Instituto de Pesquisas em Saúde - IPS, Caxias Do Sul, , Brazil
Hospital Erasto Gaertner, Curitiba, , Brazil
Oncosite - Centro de Pesquisa Clinica Oncologia, Ijui, , Brazil
Clínica de Neoplasias Litoral, Itajaí, , Brazil
UPCO - Unidade de Pesquisas Clínicas em Oncologia - Clinica Lacks, Pelotas, , Brazil
Santa Casa de Misericordia de Porto Alegre, Porto Alegre, , Brazil
Instituto Nacional de Câncer - INCA, Rio De Janeiro, , Brazil
Centro de Estudos e Pesquisa de Hematologia e Oncologia - CEPHO, Santo Andre, , Brazil
Instituto de Ensino e Pesquisas Sao Lucas, Sao Paulo, , Brazil
McGill University Health Centre, Montreal, , Canada
Santa Cabrini Hospital, Montréal, , Canada
Centro de Estudios Clínicos SAGA, Santiago de Chile, Metropolitana, Chile
Oncovida, Santiago, , Chile
Fundación Arturo Pérez López, Santiago, , Chile
Orlandi Oncología, Santiago, , Chile
Centro de Investigaciones Clinicas Vina Del Mar, Vina Del Mar, , Chile
Guangxi Medical University Affiliated Tumor Hospital, Nanning, Guangxi, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Jilin Cancer Hospital, Changchun, Jilin, China
Sichuan Cancer Hospital, Chengdu, Sichuan, China
Peking University Peoples Hospital, Beijing, , China
Peking University Cancer Hospital, Beijing, , China
Cangzhou People's Hospital, Cangzhou, , China
Hunan Cancer Hospital, Changsha, , China
Army Medical Center of PLA, Chongqing, , China
Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, , China
Haikou People's Hospital, Haikou, , China
The First Affiliated Hospital of College of Medicine Zhejiang University, Hanghzou, , China
Zhejiang Cancer Hospital, Hangzhou, , China
Harbin Medical University Cancer Hospital, Harbin, , China
Inner Mongolia Medical University- the Affiliated Hospital, Hohhot, , China
Jiamusi Tumor and Tuberculosis Hospital, Jiamusi, , China
Yunnan Cancer Hospital, Kunming, , China
Linyi Cancer Hospital, Linyi, , China
The First Affiliated Hospital of Nanchang University, Nanchang, , China
Jiangsu Province Hospital, Nanjing, , China
The Second People's Hospital of Neijiang, Neijiang, , China
Fudan University Shanghai Cancer Center, Shanghai Shi, , China
Shanghai Pulmonary Hospital, Shanghai, , China
Liaoning Cancer Hospital& Institute, Shenyang City, , China
The First Hospital of China Medical University, Shenyang, , China
Tianjin Medical University General Hospital, Tianjin, , China
Union Hospital Affiliated With Tongji Medical College Huazhong University of Science and Technology, Wuhan, , China
Hubei Cancer Hospital, Wuhan, , China
The First Affiliate Hospitalof Xi'An Jiaotong University, Xi'an, , China
The First Affiliated Hospital Xiamen University, Xiamen, , China
Xiangyang Central Hospital- 5 Lumen Avenue, Xiangyang, , China
Xinjiang Tumor Hospital, Ürümqi, , China
Bordeaux University Hospital - Hopital Saint Andre, Bordeaux, , France
Institut Bergonie, Bordeaux, , France
Centre Hospitalier Universitaire de Lille, Lille, , France
Centre Leon Berard, Lyon, , France
APHM - Hopital Nord, Marseille, , France
Centre Hospitalier Universitaire de Montpellier, Montpellier, , France
Hopital prive du Confluent, Nantes Cedex 2, , France
CHU de Nantes, Nantes, , France
AP-HP - Hopital Tenon, Paris, , France
CHU de Poitier Pole Regional de Cancerologie, Poitiers, , France
Hopital FOCH, Suresnes, , France
Evangelische Lungenklinik Berlin, Berlin, , Germany
Klinikum Esslingen GmbH, Esslingen, , Germany
LungenClinic Grosshansdorf, Grosshansdorf, , Germany
Klinikum der Universitaet Muenchen, Muenchen, , Germany
Metropolitan Hospital, Neo Faliro, Athens, Greece
Sotiria General Hosptial of Chest Diseases, Athens, , Greece
University Hospital of Ioannina Uhi, Ioannina, , Greece
Metropolitan Hospital, Neo Faliro, , Greece
Bioclinic Thessaloniki, Thessaloniki, , Greece
Prince of Wales Hospital / The Chinese University of Hong Kong 99999, Hong Kong, , Hong Kong
Queen Elizabeth Hospital, Hong Kong, , Hong Kong
Queen Mary Hospital, Pok Fu Lam, , Hong Kong
Semmelweis University Department of Pulmonology, Budapest, , Hungary
Veszprem Megyei Tudogyogyintezet Farkasgyepu, Farkasgyepű, , Hungary
Bkmk Hospital, KecskemĂŠt, , Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz, Szekesfehervar, , Hungary
Pulmonology Hospital Torokbalint, Torokbalint, , Hungary
IRCCS Istituto Oncologico Giovanni Paolo II, Bari, , Italy
UOC Oncologia, Chieti, , Italy
IRCCS Ospedale San Raffaele, Milano, , Italy
Irccs Istituto Europeo Di Oncologia, Milano, , Italy
Azienda Ospedaliera dei Colli, Naples, , Italy
A.O. Perugia Santa Maria della Misericordia, Perugia, , Italy
Policlinico Tor Vergata, Rome, , Italy
Ifo Regina Elena, Rome, , Italy
Asst Sette Laghi Ospedale di Circolo e Fondazione Macchi, Varese, , Italy
Aomori Prefectural Central Hospital, Aomori-shi, Aomori, Japan
National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan
NHO Shikoku Cancer Center, Matsuyama-shi, Ehime, Japan
National Hospital Organization Kyushu Cancer Center, Fukuoka-shi, Fukuoka, Japan
Kyushu University Hospital, Fukuoka-shi, Fukuoka, Japan
Kurume University Hospital, Kurume-shi, Fukuoka, Japan
Kanazawa University Hospital, Kanazawa-shi, Ishikawa, Japan
Kanagawa Cancer Center, Yokohama-shi, Kanagawa, Japan
Saiseikai Kumamoto Hospital, Kumamoto-shi, Kumamoto, Japan
Matsusaka Municipal Hospital, Matsusaka-shi, Mie, Japan
Sendai Kousei Hospital, Sendai-shi, Miyagi, Japan
Niigata Cancer Center Hospital, Niigata-shi, Niigata, Japan
Kansai Medical University Hospital, Hirakata-shi, Osaka, Japan
Osaka International Cancer Institute, Osaka-shi, Osaka, Japan
NHO Kinki-Chuo Chest Medical Center, Sakai-shi, Osaka, Japan
Saitama Cancer Center, Ina-machi, Saitama, Japan
Dokkyo Medical University Hospital, Shimotsuga-gun, Tochigi, Japan
Juntendo University Hospital, Bunkyo-ku, Tokyo, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Bunkyō-Ku, Tokyo, Japan
The Cancer Institute Hospital of JFCR, Koto-ku, Toyko, Japan
Toho University Omori Medical Center, Ota-ku, Toyko, Japan
NHO Iwakuni Clinical Center, Iwakuni-shi, Yamaguchi, Japan
Yamaguchi-Ube Medical Center, Ube-shi, Yamaguchi, Japan
Yamanashi Prefectural Central Hospital, Kofu-shi, , Japan
University Hospital Kyoto Prefectural University of Medicine, Kyoto-shi, , Japan
Osaka Toneyama Medical Center, Osaka, , Japan
Teine Keijinkai Hospital, Sapporo, , Japan
Chungbuk National University Hospital, Cheongju-si, Chungbuk, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do, Korea, Republic of
Gyeongsang National University Hospital, Jinju-si, Gyeongsangnam-do, Korea, Republic of
Kyungpook National University Chilgok Hospital, Daegu, , Korea, Republic of
National Cancer Center, Goyang-si, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic Univ. of Korea, Seoul St. Mary'S Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Songpa-gu, , Korea, Republic of
Cryptex Investigacion Clinica Sa de Cv, Cuauhtémoc, , Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara, , Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez, Monterrey, , Mexico
Centro de Investigacion Clinica de Oaxaca (CICLO), Oaxaca de Juarez, , Mexico
Oncologico Potosino, San Luis Potosí, , Mexico
Rijnstate Ziekenhuis, Arnhem, Gelderland, Netherlands
Amsterdam Umc, Location Vumc, Amsterdam, , Netherlands
Leiden University Medical Center, Leiden, , Netherlands
Jeroen Bosch Ziekenhuis J BZ Hieronymus Bosch Hospital, s-Hertogenbosch, , Netherlands
Instytut Centrum Zdrowia Matki Polki, Lodz, Iodzkie, Poland
Szpitale Pomorskie Sp. z o.o., Gdynia, Pomorskie, Poland
Dom Lekarski SA, Szczecin, Zachodniopomorskie, Poland
II Klinika Chorob Pluc I Gruzlicy, Bialystok, , Poland
MS Pneumed Janusz Milanowski, Katarzyna Szmygin-Milanowska Sp. Jawna, Lublin, , Poland
Centro Clinico Champalimau, Lisboa, , Portugal
Centro Hospitalar e Universitário do Porto, Porto, , Portugal
Hospital CUF Porto, Porto, , Portugal
Instituto Portuguas de Oncologia do Porto Francisco Gentil, Porto, , Portugal
Centro Hospitalar Universitário de São João, Porto, , Portugal
Onco Clinic Consult SA, Craiova, , Romania
Sc Sigmedical Services Srl, Suceava, , Romania
Oncocenter-Oncologie Clinica SRL, Timisoara, , Romania
SC Oncomed SRL, Timisoara, , Romania
Hospital Clinic i Provincial de Barcelona, Barcelona, , Spain
Hospital Universitari Vall D'Hebron, Barcelona, , Spain
Hospital Universitario Arnau de Vilanova - Lleida, Lleida, , Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Regional Universitario Malaga, Malaga, , Spain
CHUO, Ourense, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Hospital Universitario de Valme, Sevilla, , Spain
Hospital Universitari i Politècnic La Fe, Valencia, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Kantonsspital Baden, Baden, , Switzerland
University Hospital Basel, Basel, , Switzerland
Kantonsspital Baselland, Liestal, , Switzerland
E-Da Hospital, Kaohsiung City, , Taiwan
Chang Gung Memorial Hospital Cgmh - Kaohsiung Branch, Kaohsiung, , Taiwan
Chung Shan Medical University Hospital, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital Nckuh, Tainan, , Taiwan
Taipei Veterans General Hospital, Taipei City, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center, Taipei, , Taiwan
Chang Gung Memorial Hospital LinKou, Taoyuan, , Taiwan
Srinagarind Hospital, Muaeng, Khon Kaen, Thailand
Prince of Songkla University PSU - Faculty of Medicine, Hat Yai, Songkhla, Thailand
Faculty of Medicine Chulalongkorn University, Bangkok, , Thailand
Siriraj Hospital, Bangkok, , Thailand
Adana Acibadem Hospital, Adana, , Turkey
Ege University, Bornova-İzmir, , Turkey
Goztepe Prof. Dr. Suleyman Yalcin City Hospital, İstanbul, , Turkey
Medical Park Seyhan Hospital, Seyhan /Adana, , Turkey
Birmingham Heartlands Hospital, Birmingham, , United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Nottingham University Hospitals, Nottingham, , United Kingdom
Contact Details
Name: Global Clinical Leader
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR
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