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

NCT ID: NCT05215340

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

740 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-04

Study Completion Date

2028-04-30

Brief Summary

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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.

Detailed Description

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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) by BICR or Overall Survival (OS) for participants with advanced or metastatic NSCLC with non-squamous histology 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.

Conditions

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Metastatic Non Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pembrolizumab + Datopotamab Deruxtecan (Dato-DXd)

Participants will be randomized to receive 200 mg pembrolizumab followed by 6.0mg/kg Dato-DXd.

Group Type EXPERIMENTAL

Datopotamab Deruxtecan

Intervention Type DRUG

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

Pembrolizumab

Intervention Type DRUG

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

Pembrolizumb

Participants will be randomized to receive 200 mg pembrolizumab.

Group Type ACTIVE_COMPARATOR

Pembrolizumab

Intervention Type DRUG

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

Interventions

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Datopotamab Deruxtecan

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

Intervention Type DRUG

Pembrolizumab

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

Intervention Type DRUG

Other Intervention Names

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Dato-DXd KEYTRUDA®

Eligibility Criteria

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Inclusion Criteria

* 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 non-squamous NSCLC that meets all of the following criteria (Note: Subjects with squamous histology were eligible prior to Protocol Version 5.0. After Protocol Version 5.0, subjects with squamous histology are not eligible. Subjects with mixed histology, including those with a squamous component, remain eligible the study even after Protocol Version 5.0):

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 (AGAs) based on analysis of tumor tissue. If test results for EGFR, ALK, and ROS1 are not available, subjects are required to undergo testing performed locally for these genomic alterations.
3. No known AGAs 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. (Testing for genomic alterations besides EGFR, ALK, and ROS1 is not required prior to randomization). Subjects whose tumors harbor KRAS mutations are eligible for the study.
* 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 and who are asymptomatic 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 ms 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Daiichi Sankyo

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Leader

Role: STUDY_DIRECTOR

Daiichi Sankyo

Locations

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Dokkyo Medical University Hospital

Shimotsuga-gun, Tochigi, Japan

Site Status RECRUITING

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

Site Status RECRUITING

Ironwood Cancer and Research Center

Chandler, Arizona, United States

Site Status RECRUITING

UCLA HemOnc - Clinical Research Unit

Los Angeles, California, United States

Site Status RECRUITING

Compassionate Cancer Care Medical Group

Riverside, California, United States

Site Status WITHDRAWN

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Site Status WITHDRAWN

Ridley-Tree Cancer Center

Santa Barbara, California, United States

Site Status RECRUITING

PIH Health Whittier Hospital

Whittier, California, United States

Site Status RECRUITING

The Oncology Institute of Hope and Innovation

Whittier, California, United States

Site Status TERMINATED

Uch-Mhs D/B/A Memorial Health System

Colorado Springs, Colorado, United States

Site Status RECRUITING

Johns Hopkins University

Baltimore, Maryland, United States

Site Status RECRUITING

American Oncology Partners of Maryland

Bethesda, Maryland, United States

Site Status RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

DFCI - Steward St. Elizabeth's Medical Center

Boston, Massachusetts, United States

Site Status WITHDRAWN

Dana Farber Cancer Institute - Foxborough

Foxborough, Massachusetts, United States

Site Status TERMINATED

Dana Farber Cancer Institute - Milford Medical Center

Milford, Massachusetts, United States

Site Status WITHDRAWN

DFCI - South Shore Hospital

South Weymouth, Massachusetts, United States

Site Status TERMINATED

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status RECRUITING

Astera Cancer Care

East Brunswick, New Jersey, United States

Site Status RECRUITING

Regional Cancer Care Associates LLC

Freehold, New Jersey, United States

Site Status RECRUITING

Cooperman Barnabas Medical Center

New Brunswick, New Jersey, United States

Site Status TERMINATED

The Valley Hospital

Paramus, New Jersey, United States

Site Status RECRUITING

Montefiore Medical Center

The Bronx, New York, United States

Site Status RECRUITING

Arizona Oncology NAHOA

Irving, Texas, United States

Site Status RECRUITING

Cancer Care Center of Brevard

Irving, Texas, United States

Site Status RECRUITING

Illinois Cancer Specialists

Irving, Texas, United States

Site Status RECRUITING

Maryland Oncology Hematology

Irving, Texas, United States

Site Status RECRUITING

Southern Cancer Center

Irving, Texas, United States

Site Status RECRUITING

Texas Oncology - Northeast Texas

Irving, Texas, United States

Site Status RECRUITING

Texas Oncology Gulf Coast

Irving, Texas, United States

Site Status RECRUITING

Texas Oncology McAllen

Irving, Texas, United States

Site Status RECRUITING

Woodlands Medical

Irving, Texas, United States

Site Status WITHDRAWN

University of Texas Health Science Center San Antonio

San Antonio, Texas, United States

Site Status RECRUITING

Utah Cancer Specialists

Salt Lake City, Utah, United States

Site Status RECRUITING

Providence Regional Cancer System

Lacey, Washington, United States

Site Status RECRUITING

VA Puget Sound Health Care System - VAPSHCS

Seattle, Washington, United States

Site Status RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status TERMINATED

Centro de Investigaciones Medicas y Desarrollo LC S.R.L. (LC Investigacion)

Buenos Aires, , Argentina

Site Status RECRUITING

Fundacion CENIT para la investigación en Neurociencias

Ciudad Autonoma de Buenos Aire, , Argentina

Site Status RECRUITING

Hospital Privado de la Comunidad

Mar del Plata, , Argentina

Site Status RECRUITING

Centro de Investigación Pergamino S. A.

Pergamino, , Argentina

Site Status RECRUITING

Instituto de Oncología de Rosario

Rosario, , Argentina

Site Status RECRUITING

Sanatorio Parque

Rosario, , Argentina

Site Status RECRUITING

Sanatorio Británico de Rosario

Rosario, , Argentina

Site Status RECRUITING

CER SAN JUAN - Centro Polivalente de Asistencia e Investigación Clínica

San Juan, , Argentina

Site Status RECRUITING

Clinica Viedma SA

Viedma, , Argentina

Site Status RECRUITING

Austin Hospital

Heidelberg, Victoria, Australia

Site Status RECRUITING

Peninsula and South Eastern Haematology and Oncology Group

Mount Waverley, Victoria, Australia

Site Status RECRUITING

Chris Obrien Lifehouse

Camperdown, , Australia

Site Status RECRUITING

The Queen Elizabeth Hospital

Woodville South, , Australia

Site Status RECRUITING

Klinikum Klagenfurt am Wörthersee Abteilung für Lungenkrankheiten

Klagenfurt, , Austria

Site Status RECRUITING

Karl-Landsteiner Institute for Lung Research and Pulmonary Oncology c/o Klinik Floridsdorf

Vienna, , Austria

Site Status RECRUITING

Onze-Lieve-Vrouwziekenhuis Olvz - Campus Aalst

Aalst, , Belgium

Site Status RECRUITING

Grand Hopital de Charleroi - Hopital Saint Joseph

Charleroi, , Belgium

Site Status RECRUITING

Az Maria Middelares - Campus Maria Middelares

Ghent, , Belgium

Site Status RECRUITING

AZ Nikolaas

Sint-Niklaas, , Belgium

Site Status RECRUITING

Instituto de Pesquisas em Saúde - IPS

Caxias do Sul, , Brazil

Site Status RECRUITING

Hospital Erasto Gaertner

Curitiba, , Brazil

Site Status RECRUITING

Oncosite - Centro de Pesquisa Clinica Oncologia

Ijuí, , Brazil

Site Status RECRUITING

Clínica de Neoplasias Litoral

Itajaí, , Brazil

Site Status RECRUITING

UPCO - Unidade de Pesquisas Clínicas em Oncologia - Clinica Lacks

Pelotas, , Brazil

Site Status RECRUITING

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, , Brazil

Site Status RECRUITING

Instituto Nacional de Câncer - INCA

Rio de Janeiro, , Brazil

Site Status RECRUITING

Centro de Estudos e Pesquisa de Hematologia e Oncologia - CEPHO

Santo André, , Brazil

Site Status RECRUITING

Instituto de Ensino e Pesquisas Sao Lucas

São Paulo, , Brazil

Site Status RECRUITING

Instituto do Cancer Brasil - Unidade Taubate

Taubaté, , Brazil

Site Status RECRUITING

Santa Cabrini Hospital

Montreal, , Canada

Site Status WITHDRAWN

McGill University Health Centre

Montreal, , Canada

Site Status RECRUITING

Centro de Estudios Clínicos SAGA

Santiago, Santiago Metropolitan, Chile

Site Status RECRUITING

Oncovida

Santiago, , Chile

Site Status RECRUITING

Fundación Arturo Pérez López

Santiago, , Chile

Site Status RECRUITING

Orlandi Oncología

Santiago, , Chile

Site Status RECRUITING

Centro de Investigaciones Clinicas Vina Del Mar

Viña del Mar, , Chile

Site Status RECRUITING

Guangxi Medical University Affiliated Tumor Hospital

Nanning, Guangxi, China

Site Status RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

Jilin Cancer Hospital

Changchun, Jilin, China

Site Status TERMINATED

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Site Status WITHDRAWN

Peking University Peoples Hospital

Beijing, , China

Site Status RECRUITING

Peking University Cancer Hospital

Beijing, , China

Site Status RECRUITING

Cangzhou People's Hospital

Cangzhou, , China

Site Status TERMINATED

Hunan Cancer Hospital

Changsha, , China

Site Status RECRUITING

Army Medical Center of PLA

Chongqing, , China

Site Status RECRUITING

Affiliated Cancer Hospital and Institute of Guangzhou Medical University

Guangzhou, , China

Site Status RECRUITING

Haikou People's Hospital

Haikou, , China

Site Status TERMINATED

The First Affiliated Hospital of College of Medicine Zhejiang University

Hanghzou, , China

Site Status RECRUITING

Zhejiang Cancer Hospital

Hangzhou, , China

Site Status WITHDRAWN

Harbin Medical University Cancer Hospital

Harbin, , China

Site Status RECRUITING

Inner Mongolia Medical University- the Affiliated Hospital

Hohhot, , China

Site Status RECRUITING

Jiamusi Tumor and Tuberculosis Hospital

Jiamusi, , China

Site Status RECRUITING

Yunnan Cancer Hospital

Kunming, , China

Site Status TERMINATED

Linyi Cancer Hospital

Linyi, , China

Site Status RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, , China

Site Status RECRUITING

Jiangsu Province Hospital

Nanjing, , China

Site Status TERMINATED

The Second People's Hospital of Neijiang

Neijiang, , China

Site Status RECRUITING

Shanghai Pulmonary Hospital

Shanghai, , China

Site Status RECRUITING

Fudan University Shanghai Cancer Center

Shanghai Shi, , China

Site Status RECRUITING

The First Hospital of China Medical University

Shenyang, , China

Site Status RECRUITING

Liaoning Cancer Hospital& Institute

Shenyang, , China

Site Status RECRUITING

Tianjin Medical University General Hospital

Tianjin, , China

Site Status RECRUITING

Xinjiang Tumor Hospital

Ürümqi, , China

Site Status RECRUITING

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

Wuhan, , China

Site Status RECRUITING

Hubei Cancer Hospital

Wuhan, , China

Site Status RECRUITING

The First Affiliate Hospitalof Xi'An Jiaotong University

Xi'an, , China

Site Status RECRUITING

The First Affiliated Hospital Xiamen University

Xiamen, , China

Site Status RECRUITING

Xiangyang Central Hospital- 5 Lumen Avenue

Xiangyang, , China

Site Status RECRUITING

Sainte-Catherine Institut du Cancer Avignon-Provence (ICAP)

Avignon, , France

Site Status RECRUITING

Bordeaux University Hospital - Hopital Saint Andre

Bordeaux, , France

Site Status RECRUITING

Institut Bergonie

Bordeaux, , France

Site Status RECRUITING

Centre Hospitalier Universitaire de Lille

Lille, , France

Site Status RECRUITING

Centre Leon Berard

Lyon, , France

Site Status RECRUITING

APHM - Hopital Nord

Marseille, , France

Site Status RECRUITING

Institut Paoli-Calmettes

Marseille, , France

Site Status RECRUITING

Centre Hospitalier Universitaire de Montpellier

Montpellier, , France

Site Status RECRUITING

CHU de Nantes

Nantes, , France

Site Status RECRUITING

Hopital prive du Confluent

Nantes, , France

Site Status RECRUITING

AP-HP - Hopital Tenon

Paris, , France

Site Status RECRUITING

CHU de Poitier Pole Regional de Cancerologie

Poitiers, , France

Site Status RECRUITING

Hopital FOCH

Suresnes, , France

Site Status RECRUITING

Evangelische Lungenklinik Berlin

Berlin, , Germany

Site Status TERMINATED

Klinikum Esslingen GmbH

Esslingen am Neckar, , Germany

Site Status RECRUITING

LungenClinic Grosshansdorf

Großhansdorf, , Germany

Site Status RECRUITING

Klinikum der Universitaet Muenchen

München, , Germany

Site Status RECRUITING

Metropolitan Hospital

Neo Faliro, Athens, Greece

Site Status RECRUITING

Sotiria General Hosptial of Chest Diseases

Athens, , Greece

Site Status RECRUITING

University Hospital of Ioannina Uhi

Ioannina, , Greece

Site Status RECRUITING

Metropolitan Hospital

Neo Faliro, , Greece

Site Status RECRUITING

Metropolitan Hospital

Piraeus, , Greece

Site Status RECRUITING

Bioclinic Thessaloniki

Thessaloniki, , Greece

Site Status RECRUITING

St. Luke's Hospital

Thessaloniki, , Greece

Site Status RECRUITING

Prince of Wales Hospital / The Chinese University of Hong Kong 99999

Hong Kong, , Hong Kong

Site Status RECRUITING

Queen Elizabeth Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Queen Mary Hospital

Pok Fu Lam, , Hong Kong

Site Status RECRUITING

Semmelweis University Department of Pulmonology

Budapest, , Hungary

Site Status RECRUITING

Veszprem Megyei Tudogyogyintezet Farkasgyepu

Farkasgyepű, , Hungary

Site Status RECRUITING

Bkmk Hospital

KecskemĂŠt, , Hungary

Site Status RECRUITING

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

Székesfehérvár, , Hungary

Site Status RECRUITING

Pulmonology Hospital Torokbalint

Törökbálint, , Hungary

Site Status RECRUITING

IRCCS Istituto Oncologico Giovanni Paolo II

Bari, , Italy

Site Status RECRUITING

UOC Oncologia

Chieti, , Italy

Site Status RECRUITING

Ospedale San Luca

Lucca, , Italy

Site Status RECRUITING

IRCCS Ospedale San Raffaele

Milan, , Italy

Site Status RECRUITING

Irccs Istituto Europeo Di Oncologia

Milan, , Italy

Site Status RECRUITING

Azienda Ospedaliera dei Colli

Naples, , Italy

Site Status RECRUITING

A.O. Perugia Santa Maria della Misericordia

Perugia, , Italy

Site Status RECRUITING

Policlinico Tor Vergata

Rome, , Italy

Site Status RECRUITING

Ifo Regina Elena

Rome, , Italy

Site Status RECRUITING

Asst Sette Laghi Ospedale di Circolo e Fondazione Macchi

Varese, , Italy

Site Status RECRUITING

Aomori Prefectural Central Hospital

Aomori, Aomori, Japan

Site Status RECRUITING

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

Site Status RECRUITING

NHO Shikoku Cancer Center

Matsuyama, Ehime, Japan

Site Status RECRUITING

National Hospital Organization Kyushu Cancer Center

Fukuoka, Fukuoka, Japan

Site Status RECRUITING

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Site Status RECRUITING

Kurume University Hospital

Kurume-shi, Fukuoka, Japan

Site Status RECRUITING

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

Site Status RECRUITING

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

Site Status RECRUITING

Saiseikai Kumamoto Hospital

Kumamoto, Kumamoto, Japan

Site Status RECRUITING

Matsusaka Municipal Hospital

Matsusaka-shi, Mie-ken, Japan

Site Status RECRUITING

Sendai Kousei Hospital

Sendai, Miyagi, Japan

Site Status RECRUITING

Niigata Cancer Center Hospital

Niigata, Niigata, Japan

Site Status RECRUITING

Kansai Medical University Hospital

Hirakata-shi, Osaka, Japan

Site Status RECRUITING

Osaka International Cancer Institute

Osaka, Osaka, Japan

Site Status RECRUITING

NHO Kinki-Chuo Chest Medical Center

Sakai-shi, Osaka, Japan

Site Status RECRUITING

Saitama Cancer Center

Ina-machi, Saitama, Japan

Site Status WITHDRAWN

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Bunkyō-Ku, Tokyo, Japan

Site Status RECRUITING

The Cancer Institute Hospital of JFCR

Kōtoku, Toyko, Japan

Site Status RECRUITING

Toho University Omori Medical Center

Ōta-ku, Toyko, Japan

Site Status RECRUITING

NHO Iwakuni Clinical Center

Iwakuni-shi, Yamaguchi, Japan

Site Status RECRUITING

Yamaguchi-Ube Medical Center

Ube-shi, Yamaguchi, Japan

Site Status RECRUITING

Yamanashi Prefectural Central Hospital

Kofu, , Japan

Site Status RECRUITING

University Hospital Kyoto Prefectural University of Medicine

Kyoto, , Japan

Site Status RECRUITING

Osaka Toneyama Medical Center

Osaka, , Japan

Site Status RECRUITING

Teine Keijinkai Hospital

Sapporo, , Japan

Site Status RECRUITING

Cryptex Investigacion Clinica Sa de Cv

Cuauhtémoc, , Mexico

Site Status RECRUITING

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, , Mexico

Site Status RECRUITING

Hospital Universitario Dr. Jose Eleuterio Gonzalez

Monterrey, , Mexico

Site Status RECRUITING

Centro de Investigacion Clinica de Oaxaca (CICLO)

Oaxaca City, , Mexico

Site Status RECRUITING

Oncologico Potosino

San Luis Potosí City, , Mexico

Site Status RECRUITING

Rijnstate Ziekenhuis

Arnhem, Gelderland, Netherlands

Site Status RECRUITING

Jeroen Bosch Ziekenhuis J BZ Hieronymus Bosch Hospital

's-Hertogenbosch, , Netherlands

Site Status RECRUITING

Amsterdam Umc, Location Vumc

Amsterdam, , Netherlands

Site Status RECRUITING

Leiden University Medical Center

Leiden, , Netherlands

Site Status RECRUITING

Instytut Centrum Zdrowia Matki Polki

Lodz, Iodzkie, Poland

Site Status RECRUITING

Szpitale Pomorskie Sp. z o.o.

Gdynia, Pomeranian Voivodeship, Poland

Site Status RECRUITING

Dom Lekarski SA

Szczecin, West Pomeranian Voivodeship, Poland

Site Status RECRUITING

II Klinika Chorob Pluc I Gruzlicy

Bialystok, , Poland

Site Status RECRUITING

MS Pneumed Janusz Milanowski, Katarzyna Szmygin-Milanowska Sp. Jawna

Lublin, , Poland

Site Status RECRUITING

Centro Clinico Champalimau

Lisbon, , Portugal

Site Status RECRUITING

Centro Hospitalar e Universitário do Porto

Porto, , Portugal

Site Status RECRUITING

Hospital CUF Porto

Porto, , Portugal

Site Status RECRUITING

Instituto Portuguas de Oncologia do Porto Francisco Gentil

Porto, , Portugal

Site Status RECRUITING

Centro Hospitalar Universitário de São João

Porto, , Portugal

Site Status RECRUITING

Onco Clinic Consult SA

Craiova, , Romania

Site Status RECRUITING

Centrul de Oncologie Sf Nectarie S.R.L.

Craiova, , Romania

Site Status RECRUITING

Sc Sigmedical Services Srl

Suceava, , Romania

Site Status RECRUITING

Oncocenter-Oncologie Clinica SRL

Timișoara, , Romania

Site Status RECRUITING

SC Oncomed SRL

Timișoara, , Romania

Site Status RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Gyeongsang National University Hospital

Jinju, Gyeongsangnam-do, South Korea

Site Status RECRUITING

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, South Korea

Site Status RECRUITING

Kyungpook National University Chilgok Hospital

Daegu, , South Korea

Site Status RECRUITING

National Cancer Center

Goyang-si, , South Korea

Site Status RECRUITING

Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

The Catholic Univ. of Korea, Seoul St. Mary'S Hospital

Seoul, , South Korea

Site Status RECRUITING

Asan Medical Center

Songpa-gu, , South Korea

Site Status RECRUITING

Hospital Clinic i Provincial de Barcelona

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitari Vall D'Hebron

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario Arnau de Vilanova - Lleida

Lleida, , Spain

Site Status RECRUITING

Hospital General Universitario Gregorio Marañon

Madrid, , Spain

Site Status RECRUITING

Hospital Clinico San Carlos

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Fundacion Jimenez Diaz

Madrid, , Spain

Site Status RECRUITING

Hospital Regional Universitario Malaga

Málaga, , Spain

Site Status RECRUITING

CHUO

Ourense, , Spain

Site Status RECRUITING

Hospital Universitario Virgen Macarena

Seville, , Spain

Site Status RECRUITING

Hospital Universitario de Valme

Seville, , Spain

Site Status RECRUITING

Hospital Universitari i Politècnic La Fe

Valencia, , Spain

Site Status RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Site Status RECRUITING

Kantonsspital Baden

Baden, , Switzerland

Site Status RECRUITING

University Hospital Basel

Basel, , Switzerland

Site Status RECRUITING

Kantonsspital Baselland

Liestal, , Switzerland

Site Status RECRUITING

Kantonsspital St. Gallen

Sankt Gallen, , Switzerland

Site Status RECRUITING

E-Da Hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

Chang Gung Memorial Hospital Cgmh - Kaohsiung Branch

Kaohsiung City, , Taiwan

Site Status RECRUITING

Chung Shan Medical University Hospital

Taichung, , Taiwan

Site Status RECRUITING

Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status RECRUITING

National Cheng Kung University Hospital Nckuh

Tainan, , Taiwan

Site Status RECRUITING

National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, , Taiwan

Site Status RECRUITING

Chang Gung Memorial Hospital LinKou

Taoyuan District, , Taiwan

Site Status RECRUITING

Srinagarind Hospital

Muaeng, Changwat Khon Kaen, Thailand

Site Status RECRUITING

Prince of Songkla University PSU - Faculty of Medicine

Hat Yai, Changwat Songkhla, Thailand

Site Status RECRUITING

Faculty of Medicine Chulalongkorn University

Bangkok, , Thailand

Site Status RECRUITING

Siriraj Hospital

Bangkok, , Thailand

Site Status RECRUITING

Adana Acibadem Hospital

Adana, , Turkey (Türkiye)

Site Status RECRUITING

Akdeniz University Hospital

Antalya, , Turkey (Türkiye)

Site Status RECRUITING

Ege University

Bornova-İzmir, , Turkey (Türkiye)

Site Status RECRUITING

Memorial Ankara Hospital Ankara

Çankaya, , Turkey (Türkiye)

Site Status RECRUITING

Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Medical Park Seyhan Hospital

Seyhan /Adana, , Turkey (Türkiye)

Site Status RECRUITING

Birmingham Heartlands Hospital

Birmingham, , United Kingdom

Site Status RECRUITING

Beatson West of Scotland Cancer Centre

Glasgow, , United Kingdom

Site Status WITHDRAWN

Nottingham University Hospitals

Nottingham, , United Kingdom

Site Status RECRUITING

Countries

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United States Argentina Australia Austria Belgium Brazil Canada Chile China France Germany Greece Hong Kong Hungary Italy Japan Mexico Netherlands Poland Portugal Romania South Korea Spain Switzerland Taiwan Thailand Turkey (Türkiye) United Kingdom

Central Contacts

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(US Sites) Daiichi Sankyo Contact for Clinical Trial Information

Role: CONTACT

908-992-6400

(Asia Sites) Daiichi Sankyo Contact for Clinical Trial Informat

Role: CONTACT

+81-3-6225-1111(M-F 9-5 JST)

Facility Contacts

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References

Explore related publications, articles, or registry entries linked to this study.

Levy BP, Felip E, Reck M, Yang JC, Cappuzzo F, Yoneshima Y, Zhou C, Rawat S, Xie J, Basak P, Xu L, Sands J. TROPION-Lung08: phase III study of datopotamab deruxtecan plus pembrolizumab as first-line therapy for advanced NSCLC. Future Oncol. 2023 Jul;19(21):1461-1472. doi: 10.2217/fon-2023-0230. Epub 2023 May 30.

Reference Type DERIVED
PMID: 37249038 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021-002555-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

KEYNOTE-C73

Identifier Type: OTHER

Identifier Source: secondary_id

MK3475-C73

Identifier Type: OTHER

Identifier Source: secondary_id

2023-507933-12-00

Identifier Type: CTIS

Identifier Source: secondary_id

DS1062-A-U304

Identifier Type: -

Identifier Source: org_study_id

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