AzTrials
AzTrials

Metastatic Non Small Cell Lung CancerPhase 3TROPION-Lung08NCT05215340

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

A Phase 3 study testing Datopotamab Deruxtecan and Pembrolizumab in people with Metastatic Non Small Cell Lung Cancer, run by Daiichi Sankyo at 234 sites in 28 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab alone in participants with advanced or metastatic non-small cell lung cancer (NSCLC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Non Small Cell Lung Cancer
What is being tested?
Datopotamab Deruxtecan and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
740 participants
Where
234 sitesin 28 countries
Study dates
4 Mar 2022to 4 Mar 2032
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 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):
  • 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.
  • 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.
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  • 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 in the first-line setting. (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.

Who cannot join

  • 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:
  • Any agent, including an antibody-drug conjugate, containing a chemotherapeutic agent targeting topoisomerase I.
  • TROP2-targeted therapy.
  • 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).
  • 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.
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  • 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:
  • 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.
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
  • Adequately treated carcinoma in situ without evidence of disease.
  • 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:
  • 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).
  • Myocardial infarction within 6 months prior to randomization.
  • Uncontrolled angina pectoris within 6 months prior to randomization.
  • LVEF <50% by ECHO or MUGA scan within 28 days before randomization.
  • New York Heart Association Class 2 to 4 congestive heart failure (CHF) at screening.
  • 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.

Trial locations and contacts

234 sites in 28 countries.

234 sites in 28 countries

United States31 sites

  • Johns Hopkins University

    Baltimore, Maryland, 21205

  • American Oncology Partners of Maryland

    Bethesda, Maryland, 20817

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Ironwood Cancer and Research Center

    Chandler, Arizona, 85224

  • Uch-Mhs D/B/A Memorial Health System

    Colorado Springs, Colorado, 80909

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816

  • Dana Farber Cancer Institute - Foxborough

    Foxborough, Massachusetts, 02035

  • Regional Cancer Care Associates LLC

    Freehold, New Jersey, 07728

  • Arizona Oncology NAHOA

    Irving, Texas, 75063

  • Cancer Care Center of Brevard

    Irving, Texas, 75063

  • Illinois Cancer Specialists

    Irving, Texas, 75063

  • Maryland Oncology Hematology

    Irving, Texas, 75063

  • Southern Cancer Center

    Irving, Texas, 75063

  • Texas Oncology - Northeast Texas

    Irving, Texas, 75063

  • Texas Oncology Gulf Coast

    Irving, Texas, 75063

  • Texas Oncology McAllen

    Irving, Texas, 75063

  • Providence Regional Cancer System

    Lacey, Washington, 98503

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03766

  • UCLA HemOnc - Clinical Research Unit

    Los Angeles, California, 90095

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Cooperman Barnabas Medical Center

    New Brunswick, New Jersey, 08901

  • The Valley Hospital

    Paramus, New Jersey, 07652

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

  • University of Texas Health Science Center San Antonio

    San Antonio, Texas, 78229

  • Ridley-Tree Cancer Center

    Santa Barbara, California, 93105

  • VA Puget Sound Health Care System - VAPSHCS

    Seattle, Washington, 98108

  • DFCI - South Shore Hospital

    South Weymouth, Massachusetts, 02190

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • PIH Health Whittier Hospital

    Whittier, California, 90602

  • The Oncology Institute of Hope and Innovation

    Whittier, California, 90603

Other trials in United States

China31 sites

  • Peking University Peoples Hospital

    Beijing, 100044

  • Peking University Cancer Hospital

    Beijing, 100142

  • Cangzhou People's Hospital

    Cangzhou, 610001

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012

  • Hunan Cancer Hospital

    Changsha, 410013

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, 610049

  • Army Medical Center of PLA

    Chongqing, 400042

  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University

    Guangzhou, 510095

  • Haikou People's Hospital

    Haikou, 570208

  • The First Affiliated Hospital of College of Medicine Zhejiang University

    Hanghzou, 310003

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

  • Inner Mongolia Medical University- the Affiliated Hospital

    Hohhot, 10050

  • Jiamusi Tumor and Tuberculosis Hospital

    Jiamusi, 154007

  • Yunnan Cancer Hospital

    Kunming, 650118

  • Linyi Cancer Hospital

    Linyi, 276000

  • The First Affiliated Hospital of Nanchang University

    Nanchang, 330006

  • Jiangsu Province Hospital

    Nanjing, 210029

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning, Guangxi, 530021

  • The Second People's Hospital of Neijiang

    Neijiang, 641000

  • Shanghai Pulmonary Hospital

    Shanghai, 200433

  • Fudan University Shanghai Cancer Center

    Shanghai Shi, 200032

  • The First Hospital of China Medical University

    Shenyang, 110001

  • Liaoning Cancer Hospital& Institute

    Shenyang, 110801

  • Tianjin Medical University General Hospital

    Tianjin, 300052

  • Xinjiang Tumor Hospital

    Ürümqi, 830000

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

    Wuhan, 430022

  • Hubei Cancer Hospital

    Wuhan, 430079

  • The First Affiliate Hospitalof Xi'An Jiaotong University

    Xi'an, 710061

  • The First Affiliated Hospital Xiamen University

    Xiamen, 361001

  • Xiangyang Central Hospital- 5 Lumen Avenue

    Xiangyang, 441000

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

Other trials in China

Japan26 sites

  • Aomori Prefectural Central Hospital

    Aomori, Aomori, 030-8553

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo, 113-8431

  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

    Bunkyō-Ku, Tokyo, 113-8677

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, Fukuoka, 811-1395

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582

  • Kansai Medical University Hospital

    Hirakata-shi, Osaka, 573-1191

  • NHO Iwakuni Clinical Center

    Iwakuni-shi, Yamaguchi, 740-8510

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577

  • Yamanashi Prefectural Central Hospital

    Kofu

  • The Cancer Institute Hospital of JFCR

    Kōtoku, Toyko, 135-8550

  • Saiseikai Kumamoto Hospital

    Kumamoto, Kumamoto, 861- 4193

  • Kurume University Hospital

    Kurume-shi, Fukuoka, 830-0011

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • Matsusaka Municipal Hospital

    Matsusaka-shi, Mie-ken, 515-8544

  • NHO Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

  • Niigata Cancer Center Hospital

    Niigata, Niigata, 961-8566

  • Osaka International Cancer Institute

    Osaka, Osaka, 541-8567

  • Osaka Toneyama Medical Center

    Osaka, 560-8552

  • Toho University Omori Medical Center

    Ōta-ku, Toyko, 143-8541

  • NHO Kinki-Chuo Chest Medical Center

    Sakai-shi, Osaka, 591-8555

  • Teine Keijinkai Hospital

    Sapporo, 006-8555

  • Sendai Kousei Hospital

    Sendai, Miyagi, 980-0873

  • Dokkyo Medical University Hospital

    Shimotsuga-gun, Tochigi, 321-0293

  • Yamaguchi-Ube Medical Center

    Ube-shi, Yamaguchi, 755-0241

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

France13 sites

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

    Avignon, 84000

  • Bordeaux University Hospital - Hopital Saint Andre

    Bordeaux, 33075

  • Institut Bergonie

    Bordeaux, 33076

  • Centre Hospitalier Universitaire de Lille

    Lille, 59000

  • Centre Leon Berard

    Lyon, 69008

  • APHM - Hopital Nord

    Marseille, 13015

  • Institut Paoli-Calmettes

    Marseille, 13273

  • Centre Hospitalier Universitaire de Montpellier

    Montpellier, 34295

  • CHU de Nantes

    Nantes, 44093

  • Hopital prive du Confluent

    Nantes, 44277

  • AP-HP - Hopital Tenon

    Paris, 75970

  • CHU de Poitier Pole Regional de Cancerologie

    Poitiers, 86000

  • Hopital FOCH

    Suresnes, 92150

Other trials in France

Spain12 sites

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036

  • Hospital Universitari Vall D'Hebron

    Barcelona, 8035

  • Hospital Universitario Arnau de Vilanova - Lleida

    Lleida, 25198

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Regional Universitario Malaga

    Málaga, 29010

  • CHUO

    Ourense, 32005

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitario de Valme

    Seville, 41014

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Brazil10 sites

  • Instituto de Pesquisas em Saúde - IPS

    Caxias do Sul, 95020-972

  • Hospital Erasto Gaertner

    Curitiba, 81520-060

  • Oncosite - Centro de Pesquisa Clinica Oncologia

    Ijuí, 98700-000

  • Clínica de Neoplasias Litoral

    Itajaí, 88301-220

  • UPCO - Unidade de Pesquisas Clínicas em Oncologia - Clinica Lacks

    Pelotas, 96020-080

  • Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90050-170

  • Instituto Nacional de Câncer - INCA

    Rio de Janeiro, 20231-050

  • Centro de Estudos e Pesquisa de Hematologia e Oncologia - CEPHO

    Santo André, 09060-870

  • Instituto de Ensino e Pesquisas Sao Lucas

    São Paulo, 01236-030

  • Instituto do Cancer Brasil - Unidade Taubate

    Taubaté

Other trials in Brazil

Italy10 sites

  • IRCCS Istituto Oncologico Giovanni Paolo II

    Bari, 70124

  • UOC Oncologia

    Chieti, 66100

  • Ospedale San Luca

    Lucca, 55100

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • Irccs Istituto Europeo Di Oncologia

    Milan, 20141

  • Azienda Ospedaliera dei Colli

    Naples, 80131

  • A.O. Perugia Santa Maria della Misericordia

    Perugia, 06132

  • Policlinico Tor Vergata

    Rome, 133

  • Ifo Regina Elena

    Rome, 144

  • Asst Sette Laghi Ospedale di Circolo e Fondazione Macchi

    Varese, 21100

Other trials in Italy

Argentina9 sites

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

    Buenos Aires

  • Fundacion CENIT para la investigación en Neurociencias

    Ciudad Autonoma de Buenos Aire, 1125

  • Hospital Privado de la Comunidad

    Mar del Plata, B7602CBM

  • Centro de Investigación Pergamino S. A.

    Pergamino, 2700

  • Instituto de Oncología de Rosario

    Rosario, S2000

  • Sanatorio Parque

    Rosario, S2001

  • Sanatorio Británico de Rosario

    Rosario, S2002

  • CER SAN JUAN - Centro Polivalente de Asistencia e Investigación Clínica

    San Juan, 5400

  • Clinica Viedma SA

    Viedma, 8500

Other trials in Argentina

Taiwan9 sites

  • E-Da Hospital

    Kaohsiung City, 824

  • Chang Gung Memorial Hospital Cgmh - Kaohsiung Branch

    Kaohsiung City, 833

  • Chung Shan Medical University Hospital

    Taichung, 40201

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Cheng Kung University Hospital Nckuh

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, 112

  • Chang Gung Memorial Hospital LinKou

    Taoyuan, 333

Other trials in Taiwan

South Korea8 sites

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 28644

  • Kyungpook National University Chilgok Hospital

    Daegu, 42119

  • National Cancer Center

    Goyang-si, 10408

  • Gyeongsang National University Hospital

    Jinju, Gyeongsangnam-do, 52727

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Samsung Medical Center

    Seoul, 6351

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

    Seoul, 6591

  • Asan Medical Center

    Songpa-gu, 5505

Other trials in South Korea

Greece7 sites

  • Sotiria General Hosptial of Chest Diseases

    Athens, 11527

  • University Hospital of Ioannina Uhi

    Ioannina, 45500

  • Metropolitan Hospital

    Neo Faliro, Athens, 14564

  • Metropolitan Hospital

    Neo Faliro, 18547

  • Metropolitan Hospital

    Piraeus, 18547

  • Bioclinic Thessaloniki

    Thessaloniki, 54622

  • St. Luke's Hospital

    Thessaloniki, 55236

Other trials in Greece

Turkey (Türkiye)6 sites

  • Adana Acibadem Hospital

    Adana, 1130

  • Akdeniz University Hospital

    Antalya, 7070

  • Ege University

    Bornova-İzmir, 35100

  • Memorial Ankara Hospital Ankara

    Çankaya, 06520

  • Goztepe Prof. Dr. Suleyman Yalcin City Hospital

    Istanbul, 34772

  • Medical Park Seyhan Hospital

    Seyhan /Adana, 1140

Other trials in Turkey (Türkiye)

Chile5 sites

  • Centro de Estudios Clínicos SAGA

    Santiago, Santiago Metropolitan, 7500653

  • Oncovida

    Santiago, 7500000

  • Fundación Arturo Pérez López

    Santiago, 7500921

  • Orlandi Oncología

    Santiago, 7501010

  • Centro de Investigaciones Clinicas Vina Del Mar

    Viña del Mar, 254-0488

Other trials in Chile

Hungary5 sites

  • Semmelweis University Department of Pulmonology

    Budapest, 1083

  • Veszprem Megyei Tudogyogyintezet Farkasgyepu

    Farkasgyepű, 8582

  • Bkmk Hospital

    KecskemĂŠt, 6000

  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár, 8000

  • Pulmonology Hospital Torokbalint

    Törökbálint, 2045

Other trials in Hungary

Mexico5 sites

  • Cryptex Investigacion Clinica Sa de Cv

    Cuauhtémoc, 06100

  • Hospital Civil de Guadalajara Fray Antonio Alcalde

    Guadalajara, 44280

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, 64460

  • Centro de Investigacion Clinica de Oaxaca (CICLO)

    Oaxaca City, 68020

  • Oncologico Potosino

    San Luis Potosí City, 78209

Other trials in Mexico

Poland5 sites

  • II Klinika Chorob Pluc I Gruzlicy

    Bialystok, 15-450

  • Szpitale Pomorskie Sp. z o.o.

    Gdynia, Pomeranian Voivodeship, 81-519

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, Iodzkie, 93-338

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

    Lublin, 20-064

  • Dom Lekarski SA

    Szczecin, West Pomeranian Voivodeship, 70-784

Other trials in Poland

Portugal5 sites

  • Centro Clinico Champalimau

    Lisbon, 1400-038

  • Centro Hospitalar e Universitário do Porto

    Porto, 4099-001

  • Hospital CUF Porto

    Porto, 4100-180

  • Instituto Portuguas de Oncologia do Porto Francisco Gentil

    Porto, 4200-072

  • Centro Hospitalar Universitário de São João

    Porto, 4200-319

Other trials in Portugal

Romania5 sites

  • Onco Clinic Consult SA

    Craiova, 200094

  • Centrul de Oncologie Sf Nectarie S.R.L.

    Craiova, 200542

  • Sc Sigmedical Services Srl

    Suceava, 720214

  • Oncocenter-Oncologie Clinica SRL

    Timișoara, 300166

  • SC Oncomed SRL

    Timișoara, 300239

Other trials in Romania

Australia4 sites

  • Chris Obrien Lifehouse

    Camperdown, 2050

  • Austin Hospital

    Heidelberg, Victoria, 3084

  • Peninsula and South Eastern Haematology and Oncology Group

    Mount Waverley, Victoria, 3149

  • The Queen Elizabeth Hospital

    Woodville South, 5011

Other trials in Australia

Belgium4 sites

  • Onze-Lieve-Vrouwziekenhuis Olvz - Campus Aalst

    Aalst, 9300

  • Grand Hopital de Charleroi - Hopital Saint Joseph

    Charleroi, 6000

  • Az Maria Middelares - Campus Maria Middelares

    Ghent, 9000

  • AZ Nikolaas

    Sint-Niklaas, 9100

Other trials in Belgium

Germany4 sites

  • Evangelische Lungenklinik Berlin

    Berlin, 13125

  • Klinikum Esslingen GmbH

    Esslingen am Neckar, 73730

  • LungenClinic Grosshansdorf

    Großhansdorf, 22927

  • Klinikum der Universitaet Muenchen

    München, 80336

Other trials in Germany

Netherlands4 sites

  • Jeroen Bosch Ziekenhuis J BZ Hieronymus Bosch Hospital

    's-Hertogenbosch, 5223 GZ

  • Amsterdam Umc, Location Vumc

    Amsterdam, 1081 HZ

  • Rijnstate Ziekenhuis

    Arnhem, Gelderland, 6815 AD

  • Leiden University Medical Center

    Leiden, 2333 ZA

Other trials in Netherlands

Switzerland4 sites

  • Kantonsspital Baden

    Baden, 5404

  • University Hospital Basel

    Basel, 4031

  • Kantonsspital Baselland

    Liestal, A4410

  • Kantonsspital St. Gallen

    Sankt Gallen

Other trials in Switzerland

Thailand4 sites

  • Faculty of Medicine Chulalongkorn University

    Bangkok, 10330

  • Siriraj Hospital

    Bangkok, 10700

  • Prince of Songkla University PSU - Faculty of Medicine

    Hat Yai, Changwat Songkhla, 90110

  • Srinagarind Hospital

    Muaeng, Changwat Khon Kaen, 40002

Other trials in Thailand

Hong Kong3 sites

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

    Hong Kong, 99999

  • Queen Elizabeth Hospital

    Hong Kong

  • Queen Mary Hospital

    Pok Fu Lam, 999077

Other trials in Hong Kong

Austria2 sites

  • Klinikum Klagenfurt am Wörthersee Abteilung für Lungenkrankheiten

    Klagenfurt

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

    Vienna, 1090

Other trials in Austria

United Kingdom2 sites

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS

  • Nottingham University Hospitals

    Nottingham, NG5 1PB

Other trials in United Kingdom

Canada1 site

  • McGill University Health Centre

    Montreal, H4A 3J2

Other trials in Canada

About this study

Official title: A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-naïve Subjects With Advanced or Metastatic PD-L1 High (TPS ≥50%) Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung08)

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).

Read the 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) 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.

Being tested
Datopotamab Deruxtecan, Pembrolizumab
Keywords
Metastatic Non Small Cell Lung Cancer, Advanced Non Small Cell Lung Cancer, Datopotamab Deruxtecan (Dato-DXd), Pembrolizumab
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Datopotamab DeruxtecanDrug

    Also called Dato-DXd, DATROWAY®

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

  • PembrolizumabDrug

    Also called KEYTRUDA®

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

Study groups in NCT05215340
Study groupRoleWhat they receive
Pembrolizumab + Datopotamab Deruxtecan (Dato-DXd)ExperimentalParticipants will be randomized to receive 200 mg pembrolizumab followed by 6.0mg/kg Dato-DXd.
Receives: Drug: Datopotamab Deruxtecan; Drug: Pembrolizumab
PembrolizumbActive comparatorParticipants will be randomized to receive 200 mg pembrolizumab.
Receives: Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival Based on Blinded Independent Central Review in Participants With Non-Squamous Histology Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab

    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.

    Measured: From randomization until disease progression or death (whichever occurs first), up to approximately 46 months

  2. Overall Survival (OS) in Participants With Non-Squamous Histology Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab

    Overall Survival (OS) is defined as the time from randomization to death due to any cause.

    Measured: From randomization until date of death due to any cause, up to approximately 72 months

Secondary outcomes (14)

  1. PFS Based on BICR in Participants With Non-Squamous Histology, Trophoblast Cell Surface Protein 2 (TROP2) Normalized Membrane Ratio Positive (NMR+)

    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 BICR per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.

    Measured: From randomization until disease progression or death (whichever occurs first), up to approximately 72 months

  2. OS in Participants With Non-Squamous Histology, Trophoblast Cell Surface Protein 2 (TROP2) Normalized Membrane Ratio Positive (NMR+)

    Overall Survival (OS) is defined as the time from randomization to death due to any cause.

    Measured: From randomization until date of death due to any cause, up to approximately 72 months

  3. OS in All Randomized Trophoblast Cell Surface Protein 2 (TROP2) Normalized Membrane Ratio Positive (NMR+) Participants

    Overall Survival (OS) is defined as the time from randomization to death due to any cause.

    Measured: From randomization until date of death due to any cause, up to approximately 72 months

  4. OS in All Randomized Participants

    Overall Survival (OS) is defined as the time from randomization to death due to any cause.

    Measured: From randomization until date of death due to any cause, up to approximately 72 months

  5. PFS Based on BICR in All Randomized Participants With Trophoblast Cell Surface Protein 2 (TROP2) Normalized Membrane Ratio Positive (NMR+)

    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 BICR per RECIST Version 1.1.

    Measured: From randomization until disease progression or death (whichever occurs first), up to approximately 46 months

  6. PFS Based on BICR in All Randomized Participants

    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 BICR per RECIST Version 1.1.

    Measured: From randomization until disease progression on the next line of therapy or death (whichever occurs first), up to approximately 46 months

  7. PFS Based on Investigator in Participants With Non-Squamous Histology, Non-Squamous Trophoblast Cell Surface Protein 2 (TROP2) Normalized Membrane Ratio Positive (NMR+), All Randomized Participants, and All Randomized Participants That Are TROP2 NMR+

    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 Investigator per RECIST Version 1.1.

    Measured: From randomization until disease progression on the next line of therapy or death (whichever occurs first), up to approximately 46 months

  8. Progression-free Survival 2 (PFS2) in Participants With Non-Squamous Histology, Non-Squamous TROP2 NMR+, All Randomized Participants, and All Randomized Participants That Are TROP2 NMR+

    PFS2 is defined as the time from date of randomization to the first documented disease progression on next-line therapy or death due to any cause, whichever occurs first.

    Measured: From randomization until disease progression on the next line of therapy or death (whichever occurs first), up to approximately 46 months

  9. ORR by BICR and Investigator in Participants with Non-Squamous Histology, Non-Squamous Trophoblast Cell Surface Protein 2 (TROP2) Normalized Membrane Ratio Positive (NMR+), All Randomized Participants, and All Randomized Participants That Are TROP2 NMR+

    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 and by the Investigator per RECIST Version 1.1.

    Measured: From randomization to first confirmed response, up to approximately 72 months

  10. Duration of Response by BICR and Investigator in Participants with Non-Squamous Histology, Non-Squamous TROP2 NMR+, All Randomized Participants, and All Randomized Participants That Are TROP2 NMR+

    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.

    Measured: 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 72 months

  11. Time to Response by BICR and Investigator in Participants with Non-Squamous Histology, Non-Squamous TROP2 NMR+, All Randomized Participants, and All Randomized Participants That Are TROP2 NMR+

    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.

    Measured: From randomization to date of first objective response (CR or PR), up to approximately 72 months

  12. Disease Control Rate by BICR and Investigator in Participants with Non-Squamous Histology, Non-Squamous TROP2 NMR+, All Randomized Participants, and All Randomized Participants That Are TROP2 NMR+

    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.

    Measured: From randomization until disease progression or death (whichever occurs first), up to approximately 72 months

  13. Time to Deterioration in Participants with Non-Squamous Histology, Non-Squamous Trophoblast Cell Surface Protein 2 (TROP2) Normalized Membrane Ratio Positive (NMR+), All Randomized Participants, and All Randomized Participants That Are TROP2 NMR+

    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).

    Measured: From randomization to first confirmed clinically meaningful symptom deterioration, up to 72 months

  14. Number of Participants With Treatment-emergent Adverse Events (TEAE) with Non-Squamous Histology, and Separately for All Randomized Participants

    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.

    Measured: Up to 72 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2022
  2. Study start4 Mar 2022
  3. Primary completion4 Mar 2030 (estimated)
  4. Study completion4 Mar 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
740 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05215340
Sponsor's protocol ID
DS1062-A-U304
Other IDs
2021-002555-10, KEYNOTE-C73, MK3475-C73, 2023-507933-12-00, 2023
Acronym
TROPION-Lung08
Status last verified
Sep 2026
First submitted
18 Jan 2022
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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/

Publications

  • 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.

    PubMed 37249038

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Datopotamab Deruxtecan and Pembrolizumab in people with Metastatic Non Small Cell Lung Cancer, run by Daiichi Sankyo at 234 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 234 sites in United States, China, Japan, France, Spain and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival Based on Blinded Independent Central Review in Participants With Non-Squamous Histology 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 46 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05215340, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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