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ACTIVE NOT RECRUITING
NCT05555732
PHASE3

Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07)

Sponsor: Daiichi Sankyo

View on ClinicalTrials.gov

Summary

This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab in combination with pemetrexed and platinum chemotherapy in participants with no prior therapy for advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).

Official title: A Randomized Phase 3 Study of Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in Subjects With No Prior Therapy for Advanced or Metastatic PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung07)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1170

Start Date

2023-01-11

Completion Date

2029-05-11

Last Updated

2026-03-25

Healthy Volunteers

No

Interventions

DRUG

Datopotamab Deruxtecan

Dato-DXd will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.

DRUG

Pembrolizumab

Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.

DRUG

Pemetrexed

Pemetrexed will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.

DRUG

Carboplatin

Carboplatin will be administered an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.

DRUG

Cisplatin

Cisplatin will be administered an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.

Locations (254)

Southern Cancer Center Pc

Daphne, Alabama, United States

Ironwood Cancer and Research Centers

Chandler, Arizona, United States

Arizona Oncology Associates, Pc - Nahoa

Prescott Valley, Arizona, United States

Hoag Memorial Hospital Prebyterian

Newport Beach, California, United States

Compassionate Cancer Care Medical Group

Riverside, California, United States

Sansum Clinic

Santa Barbara, California, United States

Ronald Reagan UCLA Medical Center

Santa Monica, California, United States

UCHealth Memorial Hospital

Colorado Springs, Colorado, United States

Florida Cancer Specialists - South

Fort Myers, Florida, United States

Cancer Specialist of North Florida

Jacksonville, Florida, United States

Cancer Care Centers of Brevard, Inc.

Palm Bay, Florida, United States

Woodlands Medical Specialists, Pa

Pensacola, Florida, United States

Florida Cancer Specialists-North

St. Petersburg, Florida, United States

Emory University - Winship Cancer Institute Wci

Atlanta, Georgia, United States

Illinois Cancer Specialists

Niles, Illinois, United States

American Oncology Partners of Maryland

Bethesda, Maryland, United States

Maryland Oncology Heamtology P.A.

Columbia, Maryland, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana Farber Cancer Institute; Inv Drg Svc Pharm

Boston, Massachusetts, United States

Dana Farber Cancer Institute At St. Elizabeth'S Medical Center

Brighton, Massachusetts, United States

Dana Farber Brigham Cancer Center

Foxborough, Massachusetts, United States

Dana Farber At Milford Regional Cancer Center

Milford, Massachusetts, United States

Dana Farber/Bwcc in Affiliation With South Shore Hospital

South Weymouth, Massachusetts, United States

Astera Cancer Care

East Brunswick, New Jersey, United States

Regional Cancer Care Associates LLC

Hackensack, New Jersey, United States

North Shore Hematology Oncology Associates dba NY Cancer and Blood Specialists- New Hyde Park

New Hyde Park, New York, United States

North Shore Hematology Oncology Associates

Patchogue, New York, United States

North Shore Hematology Oncology Associates DBA NY Cancer and Blood Specialists

Port Jefferson Station, New York, United States

North Shore Hematology Oncology Associates dba NY Cancer and Blood Specialists - Bronx

The Bronx, New York, United States

Texas Oncology, P.A.

McAllen, Texas, United States

Ut Health San Antonio

San Antonio, Texas, United States

Texas Oncology, P.A.

Sugar Land, Texas, United States

Texas Oncology-Tyler

Tyler, Texas, United States

Utah Cancer Specialists IHO Corp

Salt Lake City, Utah, United States

Providence Regional Cancer System

Lacey, Washington, United States

VA Puget Sound Health Care System

Seattle, Washington, United States

Centro de Investigaciones Medicas y Desarrollo LC SRL

Buenos Aires, Argentina

Instituto Alexander Fleming

Buenos Aires, Argentina

Fundacion CENIT para la investigacion en Neurociencias

Ciudad Autonoma de Buenos Aire, Argentina

Hospital de La Comunidad

Mar del Plata, Argentina

Centro de Investigacion Pergamino Sa

Pergamino, Argentina

Instituto de Oncologia de Rosario

Rosario, Argentina

Sanatorio Parque

Rosario, Argentina

Sanatorio Britanico

Rosario, Argentina

Centro Polivalente de Asistencia E Investigacion Clinica Cer San Juan

San Juan, Argentina

Centro de Investigaciones Clinicas. Clinica Viedma S.A.

Viedma, Argentina

CRSA/ St Andrews Hospital

Adelaide, Australia

Flinders Medical Centre (Fmc)

Bedford Park, Australia

PSEHOG (Peninsula and South Eastern Haematology and Oncology Group)

Frankston, Australia

St George Public Hospital

Kogarah, Australia

Southern Medical Day Care Centre

Wollongong, Australia

Princess Alexandra Hospital

Woolloongabba, Australia

Landeskrankenhaus Feldkirch

Feldkirch, Austria

Klinikum Klagenfurt Pulmologie

Klagenfurt, Austria

Karl Landsteiner Institut Fã¼R Lungenforschung Und Pneumologische Onkologie C/O Klinik Floridsdorf

Vienna, Austria

Az Maria Middelares - Campus Maria Middelares

Ghent, Belgium

Centre hospitalier Jolimont-Lobbes

Haine-Saint-Paul, Belgium

Jessa Hospital

Hasselt, Belgium

Cliniques Saint Pierre Ottignies (CSPO)

Ottignies, Belgium

Az Nikolaas

Sint-Niklaas, Belgium

Personal Oncologia de Precisao - Cenantron

Belo Horizonte, Brazil

Fundaco Universidade de Caxias Do Sul- Instituto de Pesquisas Em Saude Ips-Ucs

Caxias do Sul, Brazil

Hospital Erasto Gaertner

Curitiba, Brazil

Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

Ijuí, Brazil

Clínica de Neoplasias Litoral Ltda

ItajaĂ-, Brazil

Clnica Lacks

Pelotas, Brazil

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil

Instituto Nacional de Căncer - Inca

Rio de Janeiro, Brazil

Centro de Estudos E Pesquisa de Hematologia E Oncologia - Cepho

Santo André, Brazil

Instituto de Ensino E Pesquisa Sao Lucas

São Paulo, Brazil

Instituto Do Cancer Brasil - Unidade Taubate

Taubaté, Brazil

CHU de Quebec -Universite Laval Hopital de L'Enfant-Jesus

Québec, Canada

ONCOVIDA

Santiago, Chile

Centro de Estudios Clinicos Saga Spa

Santiago, Chile

Orlandi Oncologia

Santiago, Chile

Fundacion Arturo Lopez Perez

Santiago, Chile

Centro de Investigaciones Clinicas Vina Del Mar

ViĂąa Del Mar, Chile

Oncocentro Apys

Viña del Mar, Chile

Peking University Peoples Hospital

Beijing, China

Peking University Cancer Hospital Beijing Cancer Hospital Beijing Institute For Cancer Research

Beijing Sheng, China

Cangzhou Peoples Hospital

Cangzhou, China

First Affiliated Hospital of Medical College of Jilin University

Changchun, China

Jilin Cancer Hospital

Changchun, China

Hunan Cancer Hospital

Changsha, China

University of Electronic Science Technology of China UESTC - Sichuan Cancer Hospital Institute SIC

Chengdu, China

Chongqing University Cancer Hospital

Chongqing, China

Fujian Medical University - Union Hospital Foochow Christian Union Hospital

Fuzhou, China

The First Affiliated Hospital Sun Yat-Sen University

Guangzhou, China

Affiliated Cancer Hospital and Insititute of Guangzhou Medical University

Guangzhou, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, China

The First Affiliated Hospital of College of Medicine Zhejiang University

Hangzhou, China

Harbin Medical University Cancer Hospital

Harbin, China

An Hui Cancer Hospital

Hefei, China

Inner Mongolia Medical University- the Affiliated Hospital

Hohhot, China

Jiamusi Cancer Hospital

Jiamusi, China

Linyi Cancer Hospital

Linyi, China

The First Affiliated Hospital of Nanchang University

Nanchang, China

Zhongda Hospital, Southeast University

Nanjing, China

Shanghai Chest Hospital

Shanghai, China

Fudan University Shanghai Cancer Center

Shanghai, China

Liaoning Cancer Hospital & Institute

Shenyang, China

The First Affiliated Hosptial of Xinjiang Medical University

Ürümqi, China

Union Hospital of Tongji Medical College Huazhong University of Science and Technology

Wuhan, China

The First Affiliate Hospital of Xi'An Jiaotong University

Xi'an, China

Xiangyang Central Hospital

Xianyang, China

Henan Cancer Hospital

Zhengzhou, China

FN Brno Klinika Nemoci Plicnich a TBC

Brno, Czechia

Fakultni nemocnice Olomouc FNOL

Olomouc, Czechia

Sainte-Catherine Institut du Cancer Avignon-Provence

Avignon, France

Hopital Jean Minjoz - CHU de Besancon

Besançon, France

Chu de Bordeaux - Hopital Saint Andre

Bordeaux, France

Centre Hospitalier Universitaire, CHU, de Poitiers

France, France

Hopital Lyon Sud

Lyon, France

Centre Leon Berard

Lyon, France

Institut Paoli Calmettes

Marseille, France

Aphm - Hopital Nord

Marseille, France

Chu de Montpellier

Montpellier, France

Chu de Nantes

Nantes, France

Hopital Prive Du Confluent

Nantes, France

Institut Curie

Paris, France

Tenon Hospital

Paris, France

CHU de Rennes - Hopital Pontchaillou

Rennes, France

Hôpital Foch

Suresnes, France

Evangelische Lungenklinik Berlin

Berlin, Germany

Klinikum Chemnitz

Chemnitz, Germany

Universitaetsklinikum Essen

Essen, Germany

Klinikum Esslingen Gmbh

Esslingen am Neckar, Germany

Universitaetsklinikum Freiburg

Freiburg im Breisgau, Germany

University Hospital Giessen, ZIM IV

Giessen, Germany

External pharmacy Fortuna Herstellung GmbH of main site Universitaetsmedizin Mannheim

Mannheim, Germany

Ludwig-Maximilians University Hospital of Munich

Munich, Germany

University Hospital Mănster

Münster, Germany

Sotiria General Hospital of Chest Diseases

Athens, Greece

Metropolitan Hospital - Athens

Athens, Greece

University General Hospital of Heraklion

Heraklion, Greece

University Hospital of Ioannina Uhi

Ioannina, Greece

Metropolitan Hospital

Neo Faliro, Greece

Olympion Hospital

Pátrai, Greece

Euromedica General Clinic of Thessaloniki

Thessaloniki, Greece

St. Luke's Hospital

Thessaloniki, Greece

Bioclinic Thessaloniki (Galinos Clinic)

Thessalonki, Greece

Tuen Mun Hospital

Hong Kong, Hong Kong

Prince of Wales Hospital / The Chinese University of Hong Kong

Hong Kong, Hong Kong

Queen Mary Hospital

Pok Fu Lam, Hong Kong

National Koranyi Institute For Pulmonology

Budapest, Hungary

Veszprem Megyei Tudogyogyintezet Farkasgyepu

Farkasgyepű, Hungary

Bkmk Hospital

KecskemĂŠt, Hungary

Fejer Megyei Szent Gyorgy Korhaz Pulmonologiai Osztaly

Székesfehérvár, Hungary

Hetenyi G Korhaz, Onkologiai Kozpont

Szolnok, Hungary

Reformatus Pulmonologiai Centrum

Törökbálint, Hungary

Istituto Di Candiolo Irccs

Candiolo, Italy

Ospedale San Luca

Lucca, Italy

Azienda Ospedaliero - Universitaria San Luigi Gonzaga

Orbassano, Italy

IFO Regina Elena

Rome, Italy

Ospedale S. Maria Della Misericordia

Udine, Italy

Asst Sette Laghi

Varese, Italy

Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Roma Crc - Centro Ricerche Clinich

Verona, Italy

NHO Shikoku Cancer Center

Ehime, Japan

Kurume University Hospital

Fukoka, Japan

Kyushu Cancer Center

Fukuoka, Japan

Kyushu University Hospital

Fukuoka, Japan

Teine Keijinkai Hospital

Hokkaido, Japan

Hyogo Medical University Hospital

Hyōgo, Japan

Kanazawa University Hospital

Ishikawa, Japan

Kanagawa Cancer Center

Kanagawa, Japan

Kitasato University hospital

Kanagawa, Japan

Social Welfare Organization Saiseikai Imperial Gift Foundation, Inc. Saiseikai Kumamoto Hospital

Kumamoto, Japan

University Hospital Kyoto Prefectual University of Medicine

Kyoto, Japan

Matsusaka Municipal Hospital

Mie, Japan

Sendai Kousei Hospital

Miyagi, Japan

Niigata Cancer Center Hospital

Niigata, Japan

Osaka International Cancer Institute

Osaka, Japan

Osaka Toneyama Medical Center

Osaka, Japan

Kansai Medical University Hospital

Osaka, Japan

NHO Kinki-Chuo Chest Medical Center

Osaka, Japan

Dokkyo Medical University Hospital

Tochigi, Japan

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Tokyo, Japan

Juntendo University Hospital

Tokyo, Japan

The Cancer Institute Hospital of JFCR

Tokyo, Japan

Toho University Omori Medical Center

Tokyo, Japan

Iwakuni Clinical Center

Yamaguchi, Japan

Yamaguchi-Ube Medical Center

Yamaguchi, Japan

Yamanashi Prefectural Central Hospital

Yamanashi, Japan

Cryptex Investigacion Clinica Sa de Cv

Cuauhtémoc, Mexico

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Mexico

Health Pharma Professional Research S.A de C.V.

Mexico City, Mexico

Instituto Nacional de Cancerologia

Mexico City, Mexico

Centro de Investigacion Clinica de Oaxaca CICLO

Oaxaca City, Mexico

Jeroen Bosch Ziekenhuis Jbz

's-Hertogenbosch, Netherlands

Amphia Ziekenhuis

Breda, Netherlands

Leiden University Medical Center

Leiden, Netherlands

II Klinika Chorob Pluc i Gruzlicy

Bialystok, Poland

Centrum Terapii Wspolczesnej

Lodz, Poland

Instytut Centrum Zdrowia Matki Polki (Iczmp)

Lodz, Poland

SPSK4, Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

Lublin, Poland

Med Polonia Sp. Z O.O.

Poznan, Poland

Maria Sklodowska-Curie National Research Institute of Oncology

Warsaw, Poland

Fundacao Champalimaud

Lisbon, Portugal

IPO Porto Francisco Gentil, E.P.E.

Porto, Portugal

Hospital CUF Porto

Porto, Portugal

Institute of Oncology Prof. Dr. Ion Chiricuta

Cluj-Napoca, Romania

Onco Clinic Consult Sa

Craiova, Romania

Centrul de Oncologie Sfantu Nectarie

Craiova, Romania

SC Oncomed SRL

Jud Timis, Romania

Oncocenter Oncologie Clinica S.R.L

Timișoara, Romania

Chungbuk National University Hospital

Cheongju-si, South Korea

Kyungpook National University Chilgok Hospital

Daegu, South Korea

Samsung Medical Center

Gangnam-Gu, South Korea

National Cancer Center

Goyang-si, South Korea

Gyeongsang National University Hospital

Jinju-si Gyeongsangnam-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Asan Medical Center

Seoul, South Korea

Yonsei University Health System - Severance Hospital

Seoul, South Korea

The Catholic Univ. of Korea, Seoul St. Marys Hospital

Seoul, South Korea

Vall Hebron University Hospital

Barcelona, Spain

Hospital Clinic I Provincial de Barcelona

Barcelona, Spain

Hospital Universitario Arnau de Vilanova

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

Hosp Univ Virgen Macarena

Seville, Spain

Hospital Universitario Virgen de Valme

Seville, Spain

Hospital Universitario y Politecnico de La Fe

Valenica, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

Kantonsspital Baselland

Liestal, Switzerland

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Spital Sts Ag

Thun, Switzerland

Changhua Christian Hospital

Changhua, Taiwan

China Medical University Hospital

Hsia, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Tri-Service General Hospital

Taipei, Taiwan

Linkou Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Faculty of Medicine Chulalongkorn University

Bangkok, Thailand

Ramathibodi Hospital

Bangkok, Thailand

Siriraj Hospital

Bangkok, Thailand

Chiang Mai University CMU - Maharaj Nakhon Chiang Mai Hospital Nakorn Chiang Mai Hospital

Chiang Mai, Thailand

Prince of Songkla University PSU - Faculty of Medicine

Hat Yai, Thailand

Khon Kaen University - Faculty of Medicine-Srinagarind Hospital

Nonthaburi, Thailand

Baskent University

Adana, Turkey (Türkiye)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Akdeniz University Hospital

Antalya, Turkey (Türkiye)

Medipol Mega University Hospital

Bağcılar, Turkey (Türkiye)

Ege Universitesi Gogus Hastaliklari Poliklinigi

Bornova-Izmir, Turkey (Türkiye)

Memorial Ankara Hospital

Cankaya/Ankara, Turkey (Türkiye)

Istanbul Medeniyet University Medical Faculty

Istanbul, Turkey (Türkiye)

Adana Acibadem Hospital

Seyhan, Turkey (Türkiye)

Barts Health NHS Trust

London, United Kingdom