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 (TROPION-Lung08)

April 16, 2024 updated by: Daiichi Sankyo

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)

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).

Study Overview

Status

Recruiting

Conditions

Metastatic Non Small Cell Lung Cancer

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

740

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: (US Sites) Daiichi Sankyo Contact for Clinical Trial Information
Phone Number: 908-992-6400
Email: CTRinfo@dsi.com

Study Contact Backup

Name: (Asia Sites) Daiichi Sankyo Contact for Clinical Trial Informat
Phone Number: +81-3-6225-1111(M-F 9-5 JST)
Email: dsclinicaltrial@daiichisankyo.co.jp

Study Locations

Argentina
- - Ciudad Autonoma de Buenos Aire, Argentina, 1125
    - Recruiting
    - Fundación CENIT para la Investigación en Neurociencias
    - Contact:
      
      Principal Investigator
  - Pergamino, Argentina, 2700
    - Recruiting
    - Centro de Investigación Pergamino S. A.
    - Contact:
      
      Principal Investigator
  - Rosario, Argentina, S2000
    - Recruiting
    - Instituto de Oncología de Rosario
    - Contact:
      
      Principal Investigator
  - Rosario, Argentina, S2001
    - Recruiting
    - Sanatorio Parque
    - Contact:
      
      Principal Investigator
  - Rosario, Argentina, S2002
    - Recruiting
    - Sanatorio Britanico de Rosario
    - Contact:
      
      Principal Investigator
  - San Juan, Argentina, 5400
    - Recruiting
    - CER SAN JUAN - Centro Polivalente de Asistencia e Investigación Clínica
  - Viedma, Argentina, 8500
    - Recruiting
    - Clinica Viedma SA
    - Contact:
      
      Principal Investigator
Australia
- - Camperdown, Australia, 2050
    - Recruiting
    - Chris OBrien Lifehouse
    - Contact:
      
      Principal Investigator
  - Woodville South, Australia, 5011
    - Recruiting
    - The Queen Elizabeth Hospital
    - Contact:
      
      Principal Investigator
- Victoria
  - Heidelberg, Victoria, Australia, 3084
    - Recruiting
    - Austin Hospital
    - Contact:
      
      Principal Investigator
  - Mount Waverley, Victoria, Australia, 3149
    - Recruiting
    - Peninsula and South Eastern Haematology and Oncology Group
Austria
- - Klagenfurt, Austria
    - Recruiting
    - Klinikum Klagenfurt am Wörthersee Abteilung für Lungenkrankheiten
  - Vienna, Austria, 1090
    - Recruiting
    - Karl-Landsteiner Institute for Lung Research and Pulmonary Oncology c/o Klinik Floridsdorf
Belgium
- - Aalst, Belgium, 9300
    - Recruiting
    - Onze-Lieve-Vrouwziekenhuis Olvz - Campus Aalst
    - Contact:
      
      Principal Investigator
  - Charleroi, Belgium, 6000
    - Recruiting
    - Grand Hopital de Charleroi - Hopital Saint Joseph
    - Contact:
      
      Principal Investigator
  - Gent, Belgium, 9000
    - Recruiting
    - Az Maria Middelares - Campus Maria Middelares
    - Contact:
      
      Principal Investigator
  - Sint-Niklaas, Belgium, 9100
    - Recruiting
    - AZ Nikolaas
    - Contact:
      
      Principal Investigator
Brazil
- - Caxias Do Sul, Brazil, 95020-972
    - Recruiting
    - Instituto de Pesquisas em Saúde - IPS
    - Contact:
      
      Principal Investigator
  - Curitiba, Brazil, 81520-060
    - Recruiting
    - Hospital Erasto Gaertner
  - Ijui, Brazil, 98700-000
    - Recruiting
    - Oncosite - Centro de Pesquisa Clinica Oncologia
    - Contact:
      
      Principal Investigator
  - Itajaí, Brazil, 88301-220
    - Recruiting
    - Clinica de Neoplasias Litoral
  - Pelotas, Brazil, 96020-080
    - Recruiting
    - UPCO - Unidade de Pesquisas Clínicas em Oncologia - Clinica Lacks
    - Contact:
      
      Principal Investigator
  - Porto Alegre, Brazil, 90050-170
    - Recruiting
    - Santa Casa de Misericordia de Porto Alegre
    - Contact:
      
      Principal Investigator
  - Rio De Janeiro, Brazil, 20231-050
    - Recruiting
    - Instituto Nacional de Câncer - INCA
    - Contact:
      
      Principal Investigator
  - Santo Andre, Brazil, 09060-870
    - Recruiting
    - Centro de Estudos e Pesquisa de Hematologia e Oncologia - CEPHO
    - Contact:
      
      Principal Investigator
  - Sao Paulo, Brazil, 01236-030
    - Recruiting
    - Instituto de Ensino e Pesquisas Sao Lucas
    - Contact:
      
      Principal Investigator
Canada
- - Montreal, Canada, H4A 3J2
    - Recruiting
    - McGill University Health Centre
  - Montréal, Canada, H1T 2M4
    - Recruiting
    - Santa Cabrini Hospital
    - Contact:
      
      Principal Investigator
Chile
- - Santiago, Chile, 7500000
    - Recruiting
    - Oncovida
    - Contact:
      
      Principal Investigator
  - Santiago, Chile, 7500921
    - Recruiting
    - Fundación Arturo Pérez López
    - Contact:
      
      Principal Investigator
  - Santiago, Chile, 7501010
    - Recruiting
    - Orlandi Oncologia
  - Vina Del Mar, Chile, 254-0488
    - Recruiting
    - Centro de Investigaciones Clinicas Viña del Mar
    - Contact:
      
      Principal Investigator
- Metropolitana
  - Santiago de Chile, Metropolitana, Chile, 7500653
    - Recruiting
    - Centro de Estudios Clinicos SAGA
    - Contact:
      
      Principal Investigator
China
- - Beijing, China, 100142
    - Recruiting
    - Peking University Cancer Hospital
    - Contact:
      
      Principal Investigator
  - Beijing, China, 100044
    - Recruiting
    - Peking University Peoples Hospital
    - Contact:
      
      Principal Investigator
  - Cangzhou, China, 610001
    - Recruiting
    - Cangzhou People's Hospital
  - Changsha, China, 410013
    - Recruiting
    - Hunan Cancer Hospital
    - Contact:
      
      Principal Investigator
  - Chongqing, China, 400042
    - Recruiting
    - Army Medical Center of PLA
  - Guangzhou, China, 510095
    - Recruiting
    - Affiliated Cancer Hospital and Institute of Guangzhou Medical University
    - Contact:
      
      Principal Investigator
  - Haikou, China, 570208
    - Recruiting
    - Haikou People's Hospital
    - Contact:
      
      Principal Investigator
  - Hanghzou, China, 310003
    - Recruiting
    - The First Affiliated Hospital of College of Medicine Zhejiang University
    - Contact:
      
      Principal Investigator
  - Hangzhou, China, 310022
    - Withdrawn
    - Zhejiang Cancer Hospital
  - Harbin, China, 150081
    - Recruiting
    - Harbin Medical University Cancer Hospital
    - Contact:
      
      Principal Investigator
  - Hohhot, China, 10050
    - Recruiting
    - Inner Mongolia Medical University- the Affiliated Hospital
    - Contact:
      
      Principal Investigator
  - Jiamusi, China, 154007
    - Recruiting
    - Jiamusi Tumor and Tuberculosis Hospital
    - Contact:
      
      Principal Investigator
  - Kunming, China, 650118
    - Recruiting
    - Yunnan Cancer Hospital
    - Contact:
      
      Principal Investigator
  - Linyi, China, 276000
    - Recruiting
    - Linyi Cancer Hospital
    - Contact:
      
      Principal Investigator
  - Nanchang, China, 330006
    - Recruiting
    - The First Affiliated Hospital of Nanchang University
    - Contact:
      
      Principal Investigator
  - Nanjing, China, 210029
    - Recruiting
    - Jiangsu Province Hospital
    - Contact:
      
      Principal Investigator
  - Neijiang, China, 641000
    - Recruiting
    - The second people's hospital of neijiang
    - Contact:
      
      Principal Investigator
  - Shanghai, China, 200433
    - Recruiting
    - Shanghai Pulmonary Hospital
    - Contact:
      
      Principal Investigator
  - Shanghai Shi, China, 200032
    - Recruiting
    - Fudan University Shanghai Cancer Center
    - Contact:
      
      Principal Investigator
  - Shenyang, China, 110001
    - Recruiting
    - The First Hospital of China Medical University
    - Contact:
      
      Principal Investigator
  - Shenyang City, China, 110801
    - Recruiting
    - Liaoning Cancer Hospital& Institute
    - Contact:
      
      Principal Investigator
  - Tianjin, China, 300052
    - Recruiting
    - Tianjin Medical University General Hospital
  - Wuhan, China, 430079
    - Recruiting
    - Hubei Cancer Hospital
    - Contact:
      
      Principal Investigator
  - Wuhan, China, 430022
    - Recruiting
    - Union Hospital Affiliated With Tongji Medical College Huazhong University of Science and Technology
    - Contact:
      
      Principal Investigator
  - Xi'an, China, 710061
    - Recruiting
    - The First Affiliate Hospitalof Xi'An Jiaotong University
    - Contact:
      
      Principal Investigator
  - Xiamen, China, 361001
    - Recruiting
    - The First Affiliated Hospital Xiamen University
    - Contact:
      
      Principal Investigator
  - Xiangyang, China, 441000
    - Recruiting
    - Xiangyang Central Hospital- 5 Lumen Avenue
  - Ürümqi, China, 830000
    - Recruiting
    - Xinjiang Tumor Hospital
    - Contact:
      
      Principal Investigator
- Guangxi
  - Nanning, Guangxi, China, 530021
    - Recruiting
    - Guangxi Medical University Affiliated Tumor Hospital
    - Contact:
      
      Principal Investigator
- Henan
  - Zhengzhou, Henan, China, 450008
    - Recruiting
    - Henan Cancer Hospital
    - Contact:
      
      Principal Investigator
- Jilin
  - Changchun, Jilin, China, 130012
    - Recruiting
    - Jilin Cancer Hospital
    - Contact:
      
      Principal Investigator
- Sichuan
  - Chengdu, Sichuan, China, 610049
    - Recruiting
    - Sichuan Cancer Hospital
France
- - Bordeaux, France, 33076
    - Recruiting
    - Institut Bergonie
    - Contact:
      
      Principal Investigator
  - Bordeaux, France, 33075
    - Recruiting
    - Bordeaux University Hospital - Hopital Saint Andre
  - Lille, France, 59000
    - Recruiting
    - Centre Hospitalier Universitaire de Lille
    - Contact:
      
      Principal Investigator
  - Lyon, France, 69008
    - Recruiting
    - Centre Léon Bérard
  - Marseille, France, 13015
    - Recruiting
    - APHM - Hôpital Nord
    - Contact:
      
      Principal Investigator
  - Montpellier, France, 34295
    - Recruiting
    - Centre Hospitalier Universitaire de Montpellier
    - Contact:
      
      Principal Investigator
  - Nantes, France, 44093
    - Recruiting
    - CHU de Nantes
    - Contact:
      
      Principal Investigator
  - Nantes Cedex 2, France, 44277
    - Recruiting
    - Hopital Prive du Confluent
    - Contact:
      
      Principal Investigator
  - Paris, France, 75970
    - Recruiting
    - AP-HP - Hôpital Tenon
    - Contact:
      
      Principal Investigator
  - Poitiers, France, 86000
    - Recruiting
    - CHU de Poitier Pole Regional de Cancerologie
    - Contact:
      
      Principal Investigator
  - Suresnes, France, 92150
    - Recruiting
    - Hopital Foch
    - Contact:
      
      Principal Investigator
Germany
- - Berlin, Germany, 13125
    - Recruiting
    - Evangelische Lungenklinik Berlin
    - Contact:
      
      Principal Investigator
  - Esslingen, Germany, 73730
    - Recruiting
    - Klinikum Esslingen GmbH
    - Contact:
      
      Principal Investigator
  - Grosshansdorf, Germany, 22927
    - Recruiting
    - LungenClinic Grosshansdorf
    - Contact:
      
      Principal Investigator
  - Muenchen, Germany, 80336
    - Recruiting
    - Klinikum der Universitaet Muenchen
    - Contact:
      
      Principal Investigator
Greece
- - Athens, Greece, 11527
    - Recruiting
    - Sotiria General Hosptial of Chest Diseases
    - Contact:
      
      Principal Investigator
  - Ioannina, Greece, 45500
    - Recruiting
    - University Hospital of Ioannina Uhi
    - Contact:
      
      Principal Investigator
  - Neo Faliro, Greece, 18547
    - Recruiting
    - Metropolitan Hospital
    - Contact:
      
      Principal Investigator
  - Thessaloniki, Greece, 54622
    - Recruiting
    - Bioclinic Thessaloniki
- Athens
  - Neo Faliro, Athens, Greece, 14564
    - Recruiting
    - Metropolitan Hospital
    - Contact:
      
      Principal Investigator
Hong Kong
- - Hong Kong, Hong Kong
    - Recruiting
    - Queen Elizabeth Hospital
    - Contact:
      
      Principal Investigator
  - Hong Kong, Hong Kong, 99999
    - Recruiting
    - Prince of Wales Hospital / The Chinese University of Hong Kong 99999
  - Pok Fu Lam, Hong Kong, 999077
    - Recruiting
    - Queen Mary Hospital
    - Contact:
      
      Principal Investigator
Hungary
- - Budapest, Hungary, 1083
    - Recruiting
    - Semmelweis University Department of Pulmonology
    - Contact:
      
      Principal Investigator
  - Farkasgyepű, Hungary, 8582
    - Recruiting
    - Veszprem Megyei Tudogyogyintezet Farkasgyepu
    - Contact:
      
      Principal Investigator
  - KecskemĂŠt, Hungary, 6000
    - Recruiting
    - BKMK Hospital
    - Contact:
      
      Principal Investigator
  - Szekesfehervar, Hungary, 8000
    - Recruiting
    - Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
    - Contact:
      
      Principal Investigator
  - Torokbalint, Hungary, 2045
    - Recruiting
    - Pulmonology Hospital Torokbalint
    - Contact:
      
      Principal Investigator
Italy
- - Bari, Italy, 70124
    - Recruiting
    - IRCCS Istituto Oncologico Giovanni Paolo II
    - Contact:
      
      Principal Investigator
  - Chieti, Italy, 66100
    - Recruiting
    - UOC Oncologia
    - Contact:
      
      Principal Investigator
  - Milano, Italy, 20132
    - Recruiting
    - IRCCS Ospedale San Raffaele
    - Contact:
      
      Principal Investigator
  - Milano, Italy, 20141
    - Recruiting
    - IRCCS Istituto Europeo di Oncologia
    - Contact:
      
      Principal Investigator
  - Naples, Italy, 80131
    - Recruiting
    - Azienda Ospedaliera dei Colli
    - Contact:
      
      Principal Investigator
  - Perugia, Italy, 06132
    - Recruiting
    - A.O. Perugia Santa Maria della Misericordia
    - Contact:
      
      Principal Investigator
  - Rome, Italy, 144
    - Recruiting
    - IFO Regina Elena
    - Contact:
      
      Principal Investigator
  - Rome, Italy, 133
    - Recruiting
    - Policlinico Tor Vergata
    - Contact:
      
      Principal Investigator
  - Varese, Italy, 21100
    - Recruiting
    - Asst Sette Laghi Ospedale di Circolo e Fondazione Macchi
    - Contact:
      
      Principal Investigator
Japan
- - Kofu-shi, Japan
    - Recruiting
    - Yamanashi Prefectural Central Hospital
  - Kyoto-shi, Japan, 602-8566
    - Recruiting
    - University Hospital Kyoto Prefectural University of Medicine
  - Osaka, Japan, 560-8552
    - Recruiting
    - Osaka Toneyama Medical Center
  - Sapporo, Japan, 006-8555
    - Recruiting
    - Teine Keijinkai Hospital
- Aomori
  - Aomori-shi, Aomori, Japan, 030-8553
    - Recruiting
    - Aomori Prefectural Central Hospital
    - Contact:
      
      Principal Investigator
- Chiba
  - Kashiwa-shi, Chiba, Japan, 277-8577
    - Recruiting
    - National Cancer Center Hospital East
    - Contact:
      
      Principal Investigator
- Ehime
  - Matsuyama-shi, Ehime, Japan, 791-0280
    - Recruiting
    - NHO Shikoku Cancer Center
    - Contact:
      
      Principal Investigator
- Fukuoka
  - Fukuoka-shi, Fukuoka, Japan, 812-8582
    - Recruiting
    - Kyushu University Hospital
    - Contact:
      
      Principal Investigator
  - Fukuoka-shi, Fukuoka, Japan, 811-1395
    - Recruiting
    - National Hospital Organization Kyushu Cancer Center
    - Contact:
      
      Principal Investigator
  - Kurume-shi, Fukuoka, Japan, 830-0011
    - Recruiting
    - Kurume University Hospital
    - Contact:
      
      Principal Investigator
- Ishikawa
  - Kanazawa-shi, Ishikawa, Japan, 920-8641
    - Recruiting
    - Kanazawa University Hospital
    - Contact:
      
      Principal Investigator
- Kanagawa
  - Yokohama-shi, Kanagawa, Japan, 241-8515
    - Recruiting
    - Kanagawa Cancer Center
    - Contact:
      
      Principal Investigator
- Kumamoto
  - Kumamoto-shi, Kumamoto, Japan, 861- 4193
    - Recruiting
    - Saiseikai Kumamoto Hospital
    - Contact:
      
      Principal Investigator
- Mie
  - Matsusaka-shi, Mie, Japan, 515-8544
    - Recruiting
    - Matsusaka Municipal Hospital
    - Contact:
      
      Principal Investigator
- Miyagi
  - Sendai-shi, Miyagi, Japan, 980-0873
    - Recruiting
    - Sendai Kousei Hospital
    - Contact:
      
      Principal Investigator
- Niigata
  - Niigata-shi, Niigata, Japan, 961-8566
    - Recruiting
    - Niigata Cancer Center Hospital
    - Contact:
      
      Principal Investigator
- Osaka
  - Hirakata-shi, Osaka, Japan, 573-1191
    - Recruiting
    - Kansai Medical University Hospital
    - Contact:
      
      Principal Investigator
  - Osaka-shi, Osaka, Japan, 541-8567
    - Recruiting
    - Osaka International Cancer Institute
    - Contact:
      
      Principal Investigator
  - Sakai-shi, Osaka, Japan, 591-8555
    - Recruiting
    - NHO Kinki-Chuo Chest Medical Center
    - Contact:
      
      Principal Investigator
- Saitama
  - Ina-machi, Saitama, Japan, 362-0806
    - Recruiting
    - Saitama Cancer Center
    - Contact:
      
      Principal Investigator
- Tochigi
  - Shimotsuga-gun, Tochigi, Japan, 321-0293
    - Recruiting
    - Dokkyo Medical University Hospital
    - Contact:
      
      Principal Investigator
- Tokyo
  - Bunkyo-ku, Tokyo, Japan, 113-8431
    - Recruiting
    - Juntendo University Hospital
    - Contact:
      
      Principal Investigator
  - Bunkyō-Ku, Tokyo, Japan, 113-8677
    - Recruiting
    - Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
    - Contact:
      
      Principal Investigator
- Toyko
  - Koto-ku, Toyko, Japan, 135-8550
    - Recruiting
    - The Cancer Institute Hospital of JFCR
    - Contact:
      
      Principal Investigator
  - Ota-ku, Toyko, Japan, 143-8541
    - Recruiting
    - Toho University Omori Medical Center
    - Contact:
      
      Principal Investigator
- Yamaguchi
  - Iwakuni-shi, Yamaguchi, Japan, 740-8510
    - Recruiting
    - NHO Iwakuni Clinical Center
    - Contact:
      
      Principal Investigator
  - Ube-shi, Yamaguchi, Japan, 755-0241
    - Recruiting
    - Yamaguchi-Ube Medical Center
    - Contact:
      
      Principal Investigator
Korea, Republic of
- - Daegu, Korea, Republic of, 42119
    - Recruiting
    - Kyungpook National University Chilgok Hospital
    - Contact:
      
      Principal Investigator
  - Goyang-si, Korea, Republic of, 10408
    - Recruiting
    - National Cancer Center
    - Contact:
      
      Principal Investigator
  - Seoul, Korea, Republic of, 6351
    - Recruiting
    - Samsung Medical Center
    - Contact:
      
      Principal Investigator
  - Seoul, Korea, Republic of, 6591
    - Recruiting
    - The Catholic Univ. of Korea, Seoul St. Mary'S Hospital
    - Contact:
      
      Principal Investigator
  - Songpa-gu, Korea, Republic of, 5505
    - Recruiting
    - Asan Medical Center
    - Contact:
      
      Principal Investigator
- Chungbuk
  - Cheongju-si, Chungbuk, Korea, Republic of, 28644
    - Recruiting
    - Chungbuk National University Hospital
    - Contact:
      
      Principal Investigator
- Gyeonggi-do
  - Seongnam, Gyeonggi-do, Korea, Republic of, 13620
    - Recruiting
    - Seoul National University Bundang Hospital
    - Contact:
      
      Principal Investigator
- Gyeongsangnam-do
  - Jinju-si, Gyeongsangnam-do, Korea, Republic of, 52727
    - Recruiting
    - Gyeongsang National University Hospital
Mexico
- - Cuauhtémoc, Mexico, 06100
    - Recruiting
    - Cryptex Investigacion Clinica SA de CV
    - Contact:
      
      Principal Investigator
  - Guadalajara, Mexico, 44280
    - Recruiting
    - Hospital Civil de Guadalajara Fray Antonio Alcalde
    - Contact:
      
      Principal Investigator
  - Monterrey, Mexico, 64460
    - Recruiting
    - Hospital Universitario Dr. Jose Eleuterio Gonzalez
    - Contact:
      
      Principal Investigator
  - Oaxaca de Juarez, Mexico, 68020
    - Recruiting
    - Centro de Investigacion Clinica de Oaxaca (CICLO)
    - Contact:
      
      Principal Investigator
  - San Luis Potosí, Mexico, 78209
    - Recruiting
    - Oncologico Potosino
    - Contact:
      
      Principal Investigator
Netherlands
- - Amsterdam, Netherlands, 1081 HZ
    - Recruiting
    - Amsterdam UMC, location VUmc
    - Contact:
      
      Principal Investigator
  - Leiden, Netherlands, 2333 ZA
    - Recruiting
    - Leiden University Medical Center
    - Contact:
      
      Principal Investigator
  - s-Hertogenbosch, Netherlands, 5223 GZ
    - Recruiting
    - Jeroen Bosch Ziekenhuis J BZ Hieronymus Bosch Hospital
    - Contact:
      
      Principal Investigator
- Gelderland
  - Arnhem, Gelderland, Netherlands, 6815 AD
    - Recruiting
    - Rijnstate Ziekenhuis
    - Contact:
      
      Principal Investigator
Poland
- - Bialystok, Poland, 15-450
    - Recruiting
    - II Klinika Chorob Pluc i Gruzlicy
    - Contact:
      
      Principal Investigator
  - Lublin, Poland, 20-064
    - Recruiting
    - MS Pneumed Janusz Milanowski, Katarzyna Szmygin-Milanowska Sp. Jawna
- Iodzkie
  - Lodz, Iodzkie, Poland, 93-338
    - Recruiting
    - Instytut Centrum Zdrowia Matki Polki
    - Contact:
      
      Principal Investigator
- Pomorskie
  - Gdynia, Pomorskie, Poland, 81-519
    - Recruiting
    - Szpitale Pomorskie Sp. z o.o.
- Zachodniopomorskie
  - Szczecin, Zachodniopomorskie, Poland, 70-784
    - Recruiting
    - Dom Lekarski SA
    - Contact:
      
      Principal Investigator
Portugal
- - Lisboa, Portugal, 1400-038
    - Recruiting
    - Centro Clinico Champalimau
    - Contact:
      
      Principal Investigator
  - Porto, Portugal, 4200-319
    - Recruiting
    - Centro Hospitalar Universitário de São João
  - Porto, Portugal, 4100-180
    - Recruiting
    - Hospital CUF Porto
    - Contact:
      
      Principal Investigator
  - Porto, Portugal, 4099-001
    - Recruiting
    - Centro Hospitalar e Universitário do Porto
    - Contact:
      
      Principal Investigator
  - Porto, Portugal, 4200-072
    - Recruiting
    - Instituto Portuguas de Oncologia do Porto Francisco Gentil
Romania
- - Craiova, Romania, 200094
    - Recruiting
    - Onco Clinic Consult SA
  - Suceava, Romania, 720214
    - Recruiting
    - Sc Sigmedical Services Srl
  - Timisoara, Romania, 300239
    - Recruiting
    - SC Oncomed SRL
  - Timisoara, Romania, 300166
    - Recruiting
    - Oncocenter-Oncologie Clinica SRL
Spain
- - Barcelona, Spain, 8035
    - Recruiting
    - Hospital Universitari Vall d'Hebron
    - Contact:
      
      Principal Investigator
  - Barcelona, Spain, 08036
    - Recruiting
    - Hospital Clinic i Provincial de Barcelona
    - Contact:
      
      Principal Investigator
  - Lleida, Spain, 25198
    - Recruiting
    - Hospital Universitario Arnau de Vilanova - Lleida
    - Contact:
      
      Principal Investigator
  - Madrid, Spain, 28040
    - Recruiting
    - Hospital Clinico San Carlos
    - Contact:
      
      Principal Investigator
  - Madrid, Spain, 28007
    - Recruiting
    - Hospital General Universitario Gregorio Maranon
    - Contact:
      
      Principal Investigator
  - Madrid, Spain, 28040
    - Recruiting
    - Hospital Universitario Fundacion Jimenez Diaz
    - Contact:
      
      Principal Investigator
  - Malaga, Spain, 29010
    - Recruiting
    - Hospital Regional Universitario Malaga
    - Contact:
      
      Principal Investigator
  - Ourense, Spain, 32005
    - Recruiting
    - CHUO
    - Contact:
      
      Principal Investigator
  - Sevilla, Spain, 41009
    - Recruiting
    - Hospital Universitario Virgen Macarena
    - Contact:
      
      Principal Investigator
  - Sevilla, Spain, 41014
    - Recruiting
    - Hospital Universitario de Valme
  - Valencia, Spain, 46026
    - Recruiting
    - Hospital Universitari i Politecnic La Fe
    - Contact:
      
      Principal Investigator
  - Zaragoza, Spain, 50009
    - Recruiting
    - Hospital Universitario Miguel Servet
    - Contact:
      
      Principal Investigator
Switzerland
- - Baden, Switzerland, 5404
    - Recruiting
    - Kantonsspital Baden
    - Contact:
      
      Principal Investigator
  - Basel, Switzerland, 4031
    - Recruiting
    - University Hospital Basel
    - Contact:
      
      Principal Investigator
  - Liestal, Switzerland, A4410
    - Recruiting
    - Kantonsspital Baselland
    - Contact:
      
      Principal Investigator
Taiwan
- - Kaohsiung, Taiwan, 833
    - Recruiting
    - Chang Gung Memorial Hospital CGMH - Kaohsiung Branch
    - Contact:
      
      Principal Investigator
  - Kaohsiung City, Taiwan, 824
    - Recruiting
    - E-DA hospital
    - Contact:
      
      Principal Investigator
  - Taichung, Taiwan, 40705
    - Recruiting
    - Taichung Veterans General Hospital
    - Contact:
      
      Principal Investigator
  - Taichung, Taiwan, 40201
    - Recruiting
    - Chung Shan Medical University Hospital
    - Contact:
      
      Principal Investigator
  - Tainan, Taiwan, 704
    - Recruiting
    - National Cheng Kung University Hospital NCKUH
    - Contact:
      
      Principal Investigator
  - Taipei, Taiwan, 100
    - Recruiting
    - National Taiwan University Hospital
    - Contact:
      
      Principal Investigator
  - Taipei, Taiwan, 112
    - Recruiting
    - Koo Foundation Sun Yat-Sen Cancer Center
    - Contact:
      
      Principal Investigator
  - Taipei City, Taiwan, 11217
    - Recruiting
    - Taipei Veterans General Hospital
    - Contact:
      
      Principal Investigator
  - Taoyuan, Taiwan, 333
    - Recruiting
    - Chang Gung Memorial Hospital Linkou
    - Contact:
      
      Principal Investigator
Thailand
- - Bangkok, Thailand, 10700
    - Recruiting
    - Siriraj Hospital
    - Contact:
      
      Principal Investigator
  - Bangkok, Thailand, 10330
    - Recruiting
    - Faculty of Medicine Chulalongkorn University
    - Contact:
      
      Principal Investigator
- Khon Kaen
  - Muaeng, Khon Kaen, Thailand, 40002
    - Recruiting
    - Srinagarind Hospital
    - Contact:
      
      Principal Investigator
- Songkhla
  - Hat Yai, Songkhla, Thailand, 90110
    - Recruiting
    - Prince of Songkla University PSU - Faculty of Medicine
    - Contact:
      
      Principal Investigator
Turkey
- - Adana, Turkey, 1130
    - Recruiting
    - Adana Acibadem Hospital
  - Bornova-İzmir, Turkey, 35100
    - Recruiting
    - Ege University
  - Seyhan /Adana, Turkey, 1140
    - Recruiting
    - Medical Park Seyhan Hospital
  - İstanbul, Turkey, 34772
    - Recruiting
    - Goztepe Prof. Dr. Suleyman Yalcin City Hospital
United Kingdom
- - Birmingham, United Kingdom, B9 5SS
    - Recruiting
    - Birmingham Heartlands Hospital
    - Contact:
      
      Principal Investigator
  - Glasgow, United Kingdom, G12 0YN
    - Recruiting
    - Beatson West of Scotland Cancer Centre
    - Contact:
      
      Principal Investigator
  - Nottingham, United Kingdom, NG5 1PB
    - Recruiting
    - Nottingham University Hospitals
    - Contact:
      
      Principal Investigator
United States
- Arizona
  - Chandler, Arizona, United States, 85224
    - Recruiting
    - Ironwood Cancer and Research Center
    - Contact:
      
      Principal Investigator
- California
  - Los Angeles, California, United States, 90095
    - Recruiting
    - UCLA HemOnc - Clinical Research Unit
  - Riverside, California, United States, 92501
    - Recruiting
    - Compassionate Cancer Care Medical Group
    - Contact:
      
      Principal Investigator
  - San Francisco, California, United States, 94158
    - Recruiting
    - UCSF Helen Diller Family Comprehensive Cancer Center
  - Santa Barbara, California, United States, 93105
    - Recruiting
    - Ridley-Tree Cancer Center
  - Whittier, California, United States, 90603
    - Recruiting
    - The Oncology Institute of Hope and Innovation
    - Contact:
      
      Principal Investigator
  - Whittier, California, United States, 90602
    - Recruiting
    - PIH Health Whittier Hospital
    - Contact:
      
      Principal Investigator
- Colorado
  - Colorado Springs, Colorado, United States, 80909
    - Recruiting
    - Uch-Mhs D/B/A Memorial Health System
    - Contact:
      
      Principal Investigator
- Maryland
  - Baltimore, Maryland, United States, 21205
    - Recruiting
    - Johns Hopkins University
    - Contact:
      
      Principal Investigator
  - Bethesda, Maryland, United States, 20817
    - Recruiting
    - American Oncology Partners of Maryland
    - Contact:
      
      Principal Investigator
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Recruiting
    - Beth Israel Deaconess Medical Center
  - Boston, Massachusetts, United States, 02115
    - Recruiting
    - Dana-Farber Cancer Institute
    - Contact:
      
      Principal Investigator
  - Boston, Massachusetts, United States, 02215
    - Recruiting
    - DFCI - Steward St. Elizabeth's Medical Center
  - Foxboro, Massachusetts, United States, 02035
    - Recruiting
    - Dana Farber Cancer Institute - Foxborough
  - Milford, Massachusetts, United States, 01757
    - Recruiting
    - Dana Farber Cancer Institute - Milford Medical Center
  - South Weymouth, Massachusetts, United States, 02190
    - Recruiting
    - DFCI - South Shore Hospital
- New Hampshire
  - Lebanon, New Hampshire, United States, 03766
    - Recruiting
    - Dartmouth Hitchcock Medical Center
    - Contact:
      
      Principal Investigator
- New Jersey
  - East Brunswick, New Jersey, United States, 08816
    - Recruiting
    - Astera Cancer Care
    - Contact:
      
      Principal Investigator
  - Freehold, New Jersey, United States, 07728
    - Recruiting
    - Regional Cancer Care Associates LLC
    - Contact:
      
      Principal Investigator
  - New Brunswick, New Jersey, United States, 08901
    - Recruiting
    - Cooperman Barnabas Medical Center
    - Contact:
      
      Principal Investigator
  - Paramus, New Jersey, United States, 07652
    - Recruiting
    - The Valley Hospital
    - Contact:
      
      Principal Investigator
- New York
  - Bronx, New York, United States, 10461
    - Recruiting
    - Montefiore Medical Center
    - Contact:
      
      Principal Investigator
- Texas
  - Irving, Texas, United States, 75063
    - Recruiting
    - Arizona Oncology NAHOA
  - Irving, Texas, United States, 75063
    - Recruiting
    - Cancer Care Center of Brevard
  - Irving, Texas, United States, 75063
    - Recruiting
    - Maryland Oncology Hematology
  - Irving, Texas, United States, 75063
    - Recruiting
    - Southern Cancer Center
  - Irving, Texas, United States, 75063
    - Recruiting
    - Texas Oncology - Northeast Texas
  - Irving, Texas, United States, 75063
    - Recruiting
    - Texas Oncology Gulf Coast
  - Irving, Texas, United States, 75063
    - Recruiting
    - Texas Oncology McAllen
  - Irving, Texas, United States, 75063
    - Recruiting
    - Illinois Cancer Specialists
  - Irving, Texas, United States, 75063
    - Recruiting
    - Woodlands Medical
  - San Antonio, Texas, United States, 78229
    - Recruiting
    - University of Texas Health Science Center San Antonio
    - Contact:
      
      Principal Investigator
- Utah
  - Salt Lake City, Utah, United States, 84106
    - Recruiting
    - Utah Cancer Specialists
    - Contact:
      
      Principal Investigator
- Washington
  - Lacey, Washington, United States, 98503
    - Recruiting
    - Providence Regional Cancer System
    - Contact:
      
      Principal Investigator
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53226
    - Recruiting
    - Medical College of Wisconsin
    - Contact:
      
      Principal Investigator

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Participants eligible for inclusion in the study must meet all inclusion criteria within 28 days of randomization into the study.

Sign and date the Tissue Screening and Main Informed Consent Forms, prior to the start of any study-specific qualification procedures.
Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time of informed consent.
Histologically documented NSCLC that meets all of the following criteria:
1. Stage IIIB or IIIC disease and not candidates for surgical resection or definitive chemoradiation, or Stage IV NSCLC disease at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition). Participants with early-stage NSCLC who have relapsed should be restaged during screening to ensure their eligibility for the study.
2. Documented negative test results for epidermal growth factor receptor (EGFR), lymphoma kinase (ALK), and proto-oncogene1 (ROS1) actionable genomic alterations based on analysis of tumor tissue.
3. No known actionable genomic alterations in neurotrophic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), rearranged during transfection (RET), mesenchymal-epithelial transition factor (MET), or other actionable driver kinases with locally approved therapies.
Has provided a formalin-fixed tumor tissue sample for the measurement of trophoblast cell surface protein 2 (TROP2) protein expression and for the assessment of other exploratory biomarkers.
Tumor has high programmed death receptor-1 (PD-L1) expression (TPS ≥50%) as determined by PD-L1 immunohistochemistry (IHC) 22C3 pharmDx assay by central testing (minimum of 6 slides).
Has an adequate treatment washout period before Cycle 1 Day 1.
Measurable disease based on local imaging assessment using RECIST Version 1.1.
Has left ventricular ejection fraction (LVEF) ≥50% by either an echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days before randomization.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at screening.
Has a life expectancy of at least 3 months.
Adequate bone marrow function within 7 days before randomization.

Exclusion Criteria:

Has received prior systemic treatment for advanced or metastatic NSCLC.
Has received prior treatment for NSCLC with any of the following, including in the adjuvant/neoadjuvant setting:
1. Any agent, including an antibody-drug conjugate, containing a chemotherapeutic agent targeting topoisomerase I.
2. TROP2-targeted therapy.
3. Any anti-programmed death receptor-1 (PD-1), anti-PD-L1, or anti-PD-ligand 2 (L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137).
4. Any other immune checkpoint inhibitors. Participants who received adjuvant or neoadjuvant therapy OTHER than those listed above, are eligible if the adjuvant/neoadjuvant therapy was completed at least 6 months prior to the diagnosis of advanced/metastatic disease.
Has spinal cord compression or active and untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable.
Has received prior radiotherapy ≤4 weeks of start of study intervention or more than 30 Gy (unit of ionizing radiation dose in the International System of Units) to the lung within 6 months of Cycle 1 Day 1.
History of another primary malignancy (beyond NSCLC) except for:
1. Malignancy treated with curative intent and with no known active disease ≥3 years before the first dose of study treatment and of low potential risk for recurrence.
2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
3. Adequately treated carcinoma in situ without evidence of disease.
4. Participants with a history of prostate cancer (tumor/node/metastasis stage) of Stage ≤T2cN0M0 without biochemical recurrence or progression and who in the opinion of the Investigator are not deemed to require active intervention.
Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis including radiation pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
Clinically severe pulmonary compromise, as judged by the investigator, resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, or any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement or prior complete pneumonectomy.
Uncontrolled or significant cardiovascular disease, including:
1. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) interval >470 msec regardless of sex (based on the average of the 12-lead electrocardiogram determination at screening).
2. Myocardial infarction within 6 months prior to randomization.
3. Uncontrolled angina pectoris within 6 months prior to randomization.
4. LVEF <50% by ECHO or MUGA scan within 28 days before randomization.
5. New York Heart Association Class 2 to 4 congestive heart failure (CHF) at screening.
6. Uncontrolled hypertension (resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) within 28 days before randomization.

Participants with a history of Class 2 to 4 CHF prior to screening, must have returned to Class 1 CHF and have LVEF ≥50% (by either an ECHO or MUGA scan within 28 days before randomization) in order to be eligible.

Clinically significant corneal disease.
Has received a live vaccine or live-attenuated vaccine (messenger ribonucleic acid and replication-incompetent adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of study drug. For any participant receiving an approved severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccine, please follow the vaccine label and/or local guidance.
Active, known, or suspected autoimmune disease (has an active autoimmune disease that has required systemic treatment in the past 2 years).
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosage >10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy ≤7 days prior to the first dose of study drug.
Has known human immunodeficiency virus (HIV) infection that is not well controlled.
Has an active hepatitis or uncontrolled hepatitis B or active hepatitis C infection.
Has an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
Had an allogeneic tissue/solid organ transplant.
Has a history of severe hypersensitivity reactions to either the drug or inactive ingredients (including but not limited to polysorbate 80) of Dato-DXd or pembrolizumab.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pembrolizumab + Datopotamab Deruxtecan (Dato-DXd) Participants will be randomized to receive 200 mg pembrolizumab followed by 6.0mg/kg Dato-DXd.	Drug: Datopotamab Deruxtecan Dato-DXd will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle. Other Names: Dato-DXd Drug: Pembrolizumab Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle. Other Names: KEYTRUDA®
Active Comparator: Pembrolizumb Participants will be randomized to receive 200 mg pembrolizumab.	Drug: Pembrolizumab Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle. Other Names: KEYTRUDA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival Based on Blinded Independent Central Review in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab Time Frame: From randomization until disease progression or death (whichever occurs first), up to approximately 32 months	Progression-free Survival (PFS) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.	From randomization until disease progression or death (whichever occurs first), up to approximately 32 months
Overall Survival in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab Time Frame: From randomization until date of death due to any cause, up to approximately 53 months	Overall Survival (OS) is defined as the time from randomization to death due to any cause.	From randomization until date of death due to any cause, up to approximately 53 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate by Blinded Independent Central Review in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab Time Frame: From randomization until disease progression or death (whichever occurs first), up to approximately 32 months	Objective Response Rate (ORR) is defined as the proportion of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), assessed by BICR per RECIST Version 1.1.	From randomization until disease progression or death (whichever occurs first), up to approximately 32 months
Progression-free Survival by Investigator in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab Time Frame: From randomization until disease progression or death (whichever occurs first), up to approximately 32 months	Progression-free Survival (PFS) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by the Investigator per RECIST Version 1.1.	From randomization until disease progression or death (whichever occurs first), up to approximately 32 months
Progression-free Survival 2 in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab Time Frame: From randomization until disease progression or death (whichever occurs first), up to approximately 53 months	Progression-free Survival 2 (PFS2) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by local standard clinical practice.	From randomization until disease progression or death (whichever occurs first), up to approximately 53 months
Objective Response Rate by Investigator in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab Time Frame: From randomization until disease progression or death (whichever occurs first), up to approximately 32 months	Objective Response Rate (ORR) is defined as the proportion of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), assessed by the Investigator per RECIST Version 1.1.	From randomization until disease progression or death (whichever occurs first), up to approximately 32 months
Duration of Response by BICR and Investigator in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab Time Frame: From date of first objective response (CR or PR) to date of first radiographic disease progression or death due to any cause (whichever occurs first), up to approximately 32 months	Duration of Response (DoR) is defined as the time from the date of the first documentation of objective response (confirmed CR or confirmed PR) to the date of the first radiographic disease progression or death due to any cause, whichever occurs first, assessed by BICR and by the Investigator per RECIST Version 1.1.	From date of first objective response (CR or PR) to date of first radiographic disease progression or death due to any cause (whichever occurs first), up to approximately 32 months
Time to Response by BICR and Investigator in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab Time Frame: From randomization to date of first objective response (CR or PR), up to approximately 32 months	Time to Response (TTR) is defined as the time from randomization to the date of the first documentation of objective response (confirmed CR or confirmed PR) in responding participants, assessed by BICR and by the Investigator per RECIST Version 1.1.	From randomization to date of first objective response (CR or PR), up to approximately 32 months
Disease Control Rate by BICR and Investigator in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab Time Frame: From randomization until disease progression or death (whichever occurs first), up to approximately 32 months	Disease Control Rate (DCR) is defined as the proportion of participants who achieved a BOR of confirmed CR, confirmed PR, or stable disease (SD), assessed by BICR and by the Investigator per RECIST Version 1.1.	From randomization until disease progression or death (whichever occurs first), up to approximately 32 months
Time to Deterioration in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab Time Frame: From randomization until disease progression or death (whichever occurs first), up to approximately 53 months	Time to Deterioration (TTD) is defined as the time from randomization to first onset of a ≥10-point increase in cough, chest pain, or dyspnea, confirmed by a second adjacent ≥10-point increase from randomization in the same symptom, or confirmed by death within 21 days of a ≥10-point increase from randomization, assessed the European Organization for Research and Treatment of Cancer Lung cancer module (EORTC-QLQ-LC13).	From randomization until disease progression or death (whichever occurs first), up to approximately 53 months
Number of Participants With Treatment-emergent Adverse Events (TEAE) Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab Time Frame: Up to 53 months	A TEAE is defined as an AE with a start or worsening date on or after the start date of study treatment until 37 days after the end date of study treatment.	Up to 53 months
Proportion of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) and Proportion of Participants Who Have Treatment-emergent ADA Time Frame: Baseline and up to 53 months	The immunogenicity of Dato-DXd in combination with pembrolizumab will be assessed.	Baseline and up to 53 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo

Collaborators

Merck Sharp & Dohme LLC

AstraZeneca

Investigators

Study Director: Global Clinical Leader, Daiichi Sankyo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2022

Primary Completion (Estimated)

February 29, 2028

Study Completion (Estimated)

April 30, 2028

Study Registration Dates

First Submitted

January 18, 2022

First Submitted That Met QC Criteria

January 18, 2022

First Posted (Actual)

January 31, 2022

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

DS1062-A-U304
2021-002555-10 (EudraCT Number)
KEYNOTE-C73 (Other Identifier: Merck)
MK3475-C73 (Other Identifier: Merck)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

IPD Sharing Time Frame

Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.

IPD Sharing Access Criteria

Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP
ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Daiichi Sankyo, Inc.

Recruiting

Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases (TUXEDO-2)

Breast Cancer Stage IV

Austria
Daiichi Sankyo
AstraZeneca

Available

Medical Access Program for Datopotamab Deruxtecan in NSCLC Patients

Advanced Non-Small Cell Lung Cancer | Metastatic Non Small Cell Lung Cancer

United States
AstraZeneca
Daiichi Sankyo

Active, not recruiting

A Study of Dato-DXd in Chinese Patients With Advanced Non-Small Cell Lung Cancer, Triple-negative Breast Cancer and Other Solid Tumors (TROPION-PanTumor02)

Carcinoma, Non-Small-Cell Lung | Triple Negative Breast Cancer

China
Sarah Sammons, MD
Daiichi Sankyo

Recruiting

DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs

Breast Cancer | Breast Cancer Female | Metastatic Triple-Negative Breast Carcinoma | HER2-negative Breast Cancer | HER2 Negative Breast Carcinoma | ER-negative Breast Cancer | ER Positive Breast Cancer

United States
AstraZeneca
Daiichi Sankyo

Not yet recruiting

Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer (TROPION-Lung14)

Non-small Cell Lung Cancer

China, Taiwan, Korea, Republic of, Australia
Daiichi Sankyo Co., Ltd.
AstraZeneca; Daiichi Sankyo, Inc.

Recruiting

First-in-human Study of DS-1062a for Advanced Solid Tumors (TROPION-PanTumor01)

Triple Negative Breast Cancer | Non-small Cell Lung Cancer | Hormone Receptor Positive Breast Cancer

United States, Japan
AstraZeneca

Recruiting

Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies (CERTIS1)

Advanced Solid Malignancies

United States, Korea, Republic of, Spain, Australia, Sweden, Germany, United Kingdom
AstraZeneca
Daiichi Sankyo

Recruiting

Phase 1b Study of Dato-DXd in Combination With Immunotherapy With or Without Carboplatin in Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-Lung04)

Advanced or Metastatic NSCLC

United States, Taiwan, Italy, Spain, Poland, Japan, Belgium, Turkey, France, Korea, Republic of
Daiichi Sankyo
AstraZeneca

Active, not recruiting

Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01)

Non-small Cell Lung Cancer

United States, Germany, Spain, Japan, Canada, France, Korea, Republic of, Italy, United Kingdom, China, Taiwan, Hungary, Singapore, Switzerland, Netherlands, Brazil, Mexico, Russian Federation, Puerto Rico, Poland, Hong Kong, Romania and more

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 (TROPION-Lung08)

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 Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Eligibility Criteria

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Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

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Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

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Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

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IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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