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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
Sponsor: Daiichi Sankyo
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) of non-squamous histology.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
740
Start Date
2022-03-04
Completion Date
2028-04-30
Last Updated
2026-01-07
Healthy Volunteers
No
Conditions
Interventions
Datopotamab Deruxtecan
Dato-DXd will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
Pembrolizumab
Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
Locations (243)
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
Foxborough, 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
The 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
VA Puget Sound Health Care System - VAPSHCS
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Centro de Investigaciones Medicas y Desarrollo LC S.R.L. (LC Investigacion)
Buenos Aires, Argentina
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
Ghent, 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
Ijuí, 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 André, Brazil
Instituto de Ensino e Pesquisas Sao Lucas
São Paulo, Brazil
Instituto do Cancer Brasil - Unidade Taubate
Taubaté, Brazil
Santa Cabrini Hospital
Montreal, Canada
McGill University Health Centre
Montreal, Canada
Centro de Estudios Clínicos SAGA
Santiago, Santiago Metropolitan, Chile
Oncovida
Santiago, Chile
Fundación Arturo Pérez López
Santiago, Chile
Orlandi Oncología
Santiago, Chile
Centro de Investigaciones Clinicas Vina Del Mar
Viña 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
Shanghai Pulmonary Hospital
Shanghai, China
Fudan University Shanghai Cancer Center
Shanghai Shi, China
The First Hospital of China Medical University
Shenyang, China
Liaoning Cancer Hospital& Institute
Shenyang, China
Tianjin Medical University General Hospital
Tianjin, China
Xinjiang Tumor Hospital
Ürümqi, 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
Sainte-Catherine Institut du Cancer Avignon-Provence (ICAP)
Avignon, France
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
Institut Paoli-Calmettes
Marseille, France
Centre Hospitalier Universitaire de Montpellier
Montpellier, France
CHU de Nantes
Nantes, France
Hopital prive du Confluent
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 am Neckar, Germany
LungenClinic Grosshansdorf
Großhansdorf, Germany
Klinikum der Universitaet Muenchen
München, 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
Metropolitan Hospital
Piraeus, Greece
Bioclinic Thessaloniki
Thessaloniki, Greece
St. Luke's Hospital
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
Székesfehérvár, Hungary
Pulmonology Hospital Torokbalint
Törökbálint, Hungary
IRCCS Istituto Oncologico Giovanni Paolo II
Bari, Italy
UOC Oncologia
Chieti, Italy
Ospedale San Luca
Lucca, Italy
IRCCS Ospedale San Raffaele
Milan, Italy
Irccs Istituto Europeo Di Oncologia
Milan, 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, Aomori, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
NHO Shikoku Cancer Center
Matsuyama, Ehime, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, Japan
Kurume University Hospital
Kurume-shi, Fukuoka, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Saiseikai Kumamoto Hospital
Kumamoto, Kumamoto, Japan
Matsusaka Municipal Hospital
Matsusaka-shi, Mie-ken, Japan
Sendai Kousei Hospital
Sendai, Miyagi, Japan
Niigata Cancer Center Hospital
Niigata, Niigata, Japan
Kansai Medical University Hospital
Hirakata-shi, Osaka, Japan
Osaka International Cancer Institute
Osaka, 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
Kōtoku, Toyko, Japan
Toho University Omori Medical Center
Ōta-ku, Toyko, Japan
NHO Iwakuni Clinical Center
Iwakuni-shi, Yamaguchi, Japan
Yamaguchi-Ube Medical Center
Ube-shi, Yamaguchi, Japan
Yamanashi Prefectural Central Hospital
Kofu, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Japan
Osaka Toneyama Medical Center
Osaka, Japan
Teine Keijinkai Hospital
Sapporo, Japan
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 City, Mexico
Oncologico Potosino
San Luis Potosí City, Mexico
Rijnstate Ziekenhuis
Arnhem, Gelderland, Netherlands
Jeroen Bosch Ziekenhuis J BZ Hieronymus Bosch Hospital
's-Hertogenbosch, Netherlands
Amsterdam Umc, Location Vumc
Amsterdam, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Instytut Centrum Zdrowia Matki Polki
Lodz, Iodzkie, Poland
Szpitale Pomorskie Sp. z o.o.
Gdynia, Pomeranian Voivodeship, Poland
Dom Lekarski SA
Szczecin, West Pomeranian Voivodeship, Poland
II Klinika Chorob Pluc I Gruzlicy
Bialystok, Poland
MS Pneumed Janusz Milanowski, Katarzyna Szmygin-Milanowska Sp. Jawna
Lublin, Poland
Centro Clinico Champalimau
Lisbon, 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
Centrul de Oncologie Sf Nectarie S.R.L.
Craiova, Romania
Sc Sigmedical Services Srl
Suceava, Romania
Oncocenter-Oncologie Clinica SRL
Timișoara, Romania
SC Oncomed SRL
Timișoara, Romania
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, South Korea
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
Kyungpook National University Chilgok Hospital
Daegu, South Korea
National Cancer Center
Goyang-si, South Korea
Samsung Medical Center
Seoul, South Korea
The Catholic Univ. of Korea, Seoul St. Mary'S Hospital
Seoul, South Korea
Asan Medical Center
Songpa-gu, South Korea
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
Málaga, Spain
CHUO
Ourense, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Hospital Universitario de Valme
Seville, 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
Kantonsspital St. Gallen
Sankt Gallen, Switzerland
E-Da Hospital
Kaohsiung City, Taiwan
Chang Gung Memorial Hospital Cgmh - Kaohsiung Branch
Kaohsiung City, Taiwan
Chung Shan Medical University Hospital
Taichung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Cheng Kung University Hospital Nckuh
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, Taiwan
Chang Gung Memorial Hospital LinKou
Taoyuan District, Taiwan
Srinagarind Hospital
Muaeng, Changwat Khon Kaen, Thailand
Prince of Songkla University PSU - Faculty of Medicine
Hat Yai, Changwat Songkhla, Thailand
Faculty of Medicine Chulalongkorn University
Bangkok, Thailand
Siriraj Hospital
Bangkok, Thailand
Adana Acibadem Hospital
Adana, Turkey (Türkiye)
Akdeniz University Hospital
Antalya, Turkey (Türkiye)
Ege University
Bornova-İzmir, Turkey (Türkiye)
Memorial Ankara Hospital Ankara
Çankaya, Turkey (Türkiye)
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Istanbul, Turkey (Türkiye)
Medical Park Seyhan Hospital
Seyhan /Adana, Turkey (Türkiye)
Birmingham Heartlands Hospital
Birmingham, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
Nottingham University Hospitals
Nottingham, United Kingdom