AzTrials
AzTrials

Metastatic Non Small Cell Lung CancerPhase 3NCT05555732

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

A Phase 3 study testing Datopotamab Deruxtecan, Pembrolizumab and Pemetrexed in people with Metastatic Non Small Cell Lung Cancer, run by Daiichi Sankyo at 260 sites in 29 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 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). 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, Pembrolizumab and Pemetrexed
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,170 participants
Where
260 sitesin 29 countries
Study dates
11 Jan 2023to 11 May 2031
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

  • Sign and date the Main ICF, prior to the start of any study- specific qualification procedures. Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.
  • Adults ≥18 at the time the Main ICF is signed. (Follow local regulatory requirements if the legal age of adult voluntary consent for study participation is >18 years old).
  • Has tumor with PD-L1 TPS <50% as determined by PD-L1 IHC 22C3 pharmDx assay by central testing (minimum of 6 slides). PD-L1 expression results available at the same central laboratory from screening for the purpose of entry into another Dato-DXd study may be used for tissue screening purposes in this study as long as the subject has not been randomized/enrolled in the other study.
  • Has provided a formalin-fixed tumor tissue sample (minimum of 4 × 4-micron sections or block equivalent) for the measurement of TROP2 protein expression and for the assessment of other exploratory biomarkers. This tissue requirement is in addition to the tissue required for PD-L1 testing for tissue screening purposes. If a documented law or regulation prohibits (or does not approve) sample collection, then such sample will not be collected, and the subject is still eligible for the study.
  • Has not been treated with systemic anticancer therapy for advanced or metastatic non-squamous NSCLC. Subjects who received adjuvant or neoadjuvant therapy other than those listed in the exclusion criteria are eligible if the adjuvant/ neoadjuvant therapy was completed at least 6 months prior to the diagnosis of advanced/metastatic disease and should not have progressed on or within the 6 months of completion.
  • Has measurable disease based on local imaging assessment using RECIST v1.1; radiographic tumor assessment must be performed within 28 days before randomization.

Who cannot join

  • Has received prior systemic treatment for advanced/metastatic NSCLC.
  • Has received prior treatment with any of the following, including in the adjuvant/neoadjuvant setting (for NSCLC):
  • Any agent, including an ADC, containing a chemotherapeutic agent targeting topoisomerase I
  • TROP2-targeted therapy
  • Any anti-PD-1, anti-PD-L1, or anti-programmed death-ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137)
  • Any other ICIs Subjects 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 or metastatic disease.
Show all 19Show fewer
  • Has received a live vaccine within 30 days prior to the first dose of study treatment.
  • Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed. For any subject receiving an approved severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccine, please follow the vaccine label and/or local guidance. The vaccine manufacturer and the date of administration should be recorded on the electronic case report form (Concomitant Medications page), as should any AEs relating to the vaccine (including hypersensitivity or allergies). Note: Any licensed SARS-CoV2 vaccine (including those authorized for emergency use) in a particular country is allowed in the study as long as the vaccine is an mRNA vaccine, replication-incompetent adenoviral vaccine, or inactivated vaccine. Such vaccines will be treated just as any other concomitant therapy.
  • Investigational vaccines (ie, those not licensed or authorized for emergency use) are not allowed.
  • Has spinal cord compression or clinically active untreated CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression) for at least 2 weeks by repeat imaging (Note: Repeat imaging should be performed during study screening), clinically stable, and without requirement of steroid treatment for at least 7 days before the first dose of study drug. Note: A contrasted computed tomography (CT) scan or magnetic resonance imaging (MRI) scan of the brain at baseline (MRI with contrast preferred) is required for all subjects. For those subjects in whom CNS metastases are first discovered at the time of screening, the treating investigator must delay of study treatment to document stability of CNS metastases with repeat imaging at least 2 weeks later (in which case, repeat of all screening activity may be required).
  • Has uncontrolled or significant cardiovascular disease not controlled by maximal medical therapy, including:
  • Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) interval >470 msec regardless of sex (based on the 12-lead electrocardiogram [ECG] performed at screening).
  • Myocardial infarction within 6 months prior to Cycle 1 Day 1.
  • History of a serious cardiac arrhythmia requiring treatment
  • Uncontrolled angina pectoris within 6 months prior to Cycle 1 Day 1.
  • Left ventricular ejection fraction (LVEF) <50% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before randomization.
  • New York Heart Association (NYHA) Class II-IV congestive heart failure (CHF) at screening. Subjects with a history of Class II to IV CHF prior to screening, must have returned to Class I CHF and have LVEF ≥50% (by either an ECHO or MUGA scan within 28 days before randomization) in order to be eligible.
  • Uncontrolled hypertension (resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg within 28 days before randomization that is not resolved despite maximal medical therapy).
  • Clinically severe pulmonary compromise as judged by the investigator resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli diagnosed within 3 months of Cycle 1 Day 1, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc) or any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (eg, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc), or prior complete pneumonectomy.

Trial locations and contacts

260 sites in 29 countries.

260 sites in 29 countries

United States36 sites

  • Emory University - Winship Cancer Institute Wci

    Atlanta, Georgia, 30322-1013

  • American Oncology Partners of Maryland

    Bethesda, Maryland, 20817

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute; Inv Drg Svc Pharm

    Boston, Massachusetts, 02215

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

    Brighton, Massachusetts, 02135

  • Ironwood Cancer and Research Centers

    Chandler, Arizona, 85224

  • UCHealth Memorial Hospital

    Colorado Springs, Colorado, 80909

  • Maryland Oncology Heamtology P.A.

    Columbia, Maryland, 21044

  • Southern Cancer Center Pc

    Daphne, Alabama, 36526

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816

  • Florida Cancer Specialists - South

    Fort Myers, Florida, 33901

  • Dana Farber Brigham Cancer Center

    Foxborough, Massachusetts, 02035

  • Regional Cancer Care Associates LLC

    Hackensack, New Jersey, 07601

  • Cancer Specialist of North Florida

    Jacksonville, Florida, 32256

  • Providence Regional Cancer System

    Lacey, Washington, 98503

  • Texas Oncology, P.A.

    McAllen, Texas, 78503

  • Dana Farber At Milford Regional Cancer Center

    Milford, Massachusetts, 01757

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

    New Hyde Park, New York, 11042

  • Hoag Memorial Hospital Prebyterian

    Newport Beach, California, 92663

  • Illinois Cancer Specialists

    Niles, Illinois, 60714

  • Cancer Care Centers of Brevard, Inc.

    Palm Bay, Florida, 32901

  • North Shore Hematology Oncology Associates

    Patchogue, New York, 11772

  • Woodlands Medical Specialists, Pa

    Pensacola, Florida, 32503

  • North Shore Hematology Oncology Associates DBA NY Cancer and Blood Specialists

    Port Jefferson Station, New York, 11776

  • Arizona Oncology Associates, Pc - Nahoa

    Prescott Valley, Arizona, 86314

  • Compassionate Cancer Care Medical Group

    Riverside, California, 92501

  • Utah Cancer Specialists IHO Corp

    Salt Lake City, Utah, 84106

  • Ut Health San Antonio

    San Antonio, Texas, 78229

  • Sansum Clinic

    Santa Barbara, California, 93105

  • Ronald Reagan UCLA Medical Center

    Santa Monica, California, 90404

  • VA Puget Sound Health Care System

    Seattle, Washington, 98108

  • Dana Farber/Bwcc in Affiliation With South Shore Hospital

    South Weymouth, Massachusetts, 02190

  • Florida Cancer Specialists-North

    St. Petersburg, Florida, 33705

  • Texas Oncology, P.A.

    Sugar Land, Texas, 77479

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

    The Bronx, New York, 10469

  • Texas Oncology-Tyler

    Tyler, Texas, 75702

Other trials in United States

China33 sites

  • Peking University Peoples Hospital

    Beijing, 100044

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

    Beijing Sheng, 100142

  • Cangzhou Peoples Hospital

    Cangzhou, 061000

  • First Affiliated Hospital of Medical College of Jilin University

    Changchun, 130000

  • Jilin Cancer Hospital

    Changchun, 130000

  • Hunan Cancer Hospital

    Changsha, 410011

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

    Chengdu, 610041

  • Chongqing University Cancer Hospital

    Chongqing, 400030

  • Fujian Medical University - Union Hospital Foochow Christian Union Hospital

    Fuzhou, 350001

  • The First Affiliated Hospital Sun Yat-Sen University

    Guangzhou, 510080

  • Affiliated Cancer Hospital and Insititute of Guangzhou Medical University

    Guangzhou, 510095

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120

  • Haikou Peoples Hospital

    Haikou, 570208

  • Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, 310000

  • The First Affiliated Hospital of College of Medicine Zhejiang University

    Hangzhou, 310003

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

  • An Hui Cancer Hospital

    Hefei

  • Inner Mongolia Medical University- the Affiliated Hospital

    Hohhot, 010050

  • Jiamusi Cancer Hospital

    Jiamusi, 154007

  • Linyi Cancer Hospital

    Linyi, 276000

  • The First Affiliated Hospital of Nanchang University

    Nanchang, 330006

  • Zhongda Hospital, Southeast University

    Nanjing, 210009

  • The Second Peoples Hospital of Neijiang

    Neijiang Shi, 641000

  • Shanghai Chest Hospital

    Shanghai, 200030

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

  • Liaoning Cancer Hospital & Institute

    Shenyang, 110042

  • Tianjin Medical University General Hospital

    Tianjin, 300052

  • The First Affiliated Hosptial of Xinjiang Medical University

    Ürümqi, 830000

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

    Wuhan, 430022

  • Hubei Cancer Hospital

    Wuhan, 430079

  • The First Affiliate Hospital of Xi'An Jiaotong University

    Xi'an, 710061

  • Xiangyang Central Hospital

    Xianyang, 441021

  • Henan Cancer Hospital

    Zhengzhou, 450003

Other trials in China

Japan26 sites

  • NHO Shikoku Cancer Center

    Ehime

  • Kurume University Hospital

    Fukoka, 830-0011

  • Kyushu Cancer Center

    Fukuoka, 811-1395

  • Kyushu University Hospital

    Fukuoka, 812-0054

  • Teine Keijinkai Hospital

    Hokkaido, 006-0811

  • Hyogo Medical University Hospital

    Hyōgo, 663-8501

  • Kanazawa University Hospital

    Ishikawa, 920-8641

  • Kanagawa Cancer Center

    Kanagawa, 241-8515

  • Kitasato University hospital

    Kanagawa, 252-0375

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

    Kumamoto, 861-4193

  • University Hospital Kyoto Prefectual University of Medicine

    Kyoto, 602-8566

  • Saiseikai Matsusaka Municipal Hospital

    Mie, 515-8544

  • Sendai Kousei Hospital

    Miyagi, 981-0914

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Osaka International Cancer Institute

    Osaka, 540-0008

  • Osaka Toneyama Medical Center

    Osaka, 560-8552

  • Kansai Medical University Hospital

    Osaka, 573-1191

  • NHO Kinki-Chuo Chest Medical Center

    Osaka, 591-8555

  • Dokkyo Medical University Hospital

    Tochigi, 321-0293

  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

    Tokyo, 113-0021

  • Juntendo University Hospital

    Tokyo, 113-8431

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-0063

  • Toho University Omori Medical Center

    Tokyo, 143-8540

  • Iwakuni Clinical Center

    Yamaguchi, 740-8510

  • Yamaguchi-Ube Medical Center

    Yamaguchi, 755-0241

  • Yamanashi Prefectural Central Hospital

    Yamanashi, 400-8506

Other trials in Japan

France15 sites

  • Sainte-Catherine Institut du Cancer Avignon-Provence

    Avignon

  • Hopital Jean Minjoz - CHU de Besancon

    Besançon, 25000

  • Chu de Bordeaux - Hopital Saint Andre

    Bordeaux, 33075

  • Centre Hospitalier Universitaire, CHU, de Poitiers

    France, 86021

  • Hopital Lyon Sud

    Lyon, 69003

  • Centre Leon Berard

    Lyon, 69008

  • Institut Paoli Calmettes

    Marseille, 13009

  • Aphm - Hopital Nord

    Marseille, 13015

  • Chu de Montpellier

    Montpellier, 34295

  • Chu de Nantes

    Nantes, 44000

  • Hopital Prive Du Confluent

    Nantes, 44277

  • Institut Curie

    Paris, 75005

  • Tenon Hospital

    Paris, 75020

  • CHU de Rennes - Hopital Pontchaillou

    Rennes, 35033

  • Hôpital Foch

    Suresnes, 92150

Other trials in France

Spain12 sites

  • Vall Hebron University Hospital

    Barcelona, 08035

  • Hospital Clinic I Provincial de Barcelona

    Barcelona, 8036

  • Hospital Universitario Arnau de Vilanova

    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, 29011

  • CHUO

    Ourense, 32005

  • Hosp Univ Virgen Macarena

    Seville, 41009

  • Hospital Universitario Virgen de Valme

    Seville, 41014

  • Hospital Universitario y Politecnico de La Fe

    Valenica, 46026

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Brazil11 sites

  • Personal Oncologia de Precisao - Cenantron

    Belo Horizonte, 30130 090

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

    Caxias do Sul, 95070-560

  • Hospital Erasto Gaertner

    Curitiba, 81520-060

  • Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

    Ijuí, 98700-000

  • Clínica de Neoplasias Litoral Ltda

    ItajaĂ-, 88301-220

  • Clnica Lacks

    Pelotas, 96020-080

  • Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90050-170

  • Instituto Nacional de Căncer - Inca

    Rio de Janeiro, 20231-050

  • Centro de Estudos E Pesquisa de Hematologia E Oncologia - Cepho

    Santo André, 09060-870

  • Instituto de Ensino E Pesquisa Sao Lucas

    São Paulo, 01236-030

  • Instituto Do Cancer Brasil - Unidade Taubate

    Taubaté, 12030-200

Other trials in Brazil

Argentina10 sites

  • Centro de Investigaciones Medicas y Desarrollo LC SRL

    Buenos Aires

  • Instituto Alexander Fleming

    Buenos Aires

  • Fundacion CENIT para la investigacion en Neurociencias

    Ciudad Autonoma de Buenos Aire, 1125

  • Hospital de La Comunidad

    Mar del Plata, 7600

  • Centro de Investigacion Pergamino Sa

    Pergamino, B2700

  • Instituto de Oncologia de Rosario

    Rosario, 2000DSK

  • Sanatorio Parque

    Rosario, S2000DSV

  • Sanatorio Britanico

    Rosario

  • Centro Polivalente de Asistencia E Investigacion Clinica Cer San Juan

    San Juan, 5400

  • Centro de Investigaciones Clinicas. Clinica Viedma S.A.

    Viedma, 8500

Other trials in Argentina

Germany9 sites

  • Evangelische Lungenklinik Berlin

    Berlin, 13125

  • Klinikum Chemnitz

    Chemnitz, 9116

  • Universitaetsklinikum Essen

    Essen, 45147

  • Klinikum Esslingen Gmbh

    Esslingen am Neckar, 73730

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • University Hospital Giessen, ZIM IV

    Giessen

  • External pharmacy Fortuna Herstellung GmbH of main site Universitaetsmedizin Mannheim

    Mannheim

  • Ludwig-Maximilians University Hospital of Munich

    Munich, 80336

  • University Hospital Mănster

    Münster, 48149

Other trials in Germany

Greece9 sites

  • Sotiria General Hospital of Chest Diseases

    Athens, 11527

  • Metropolitan Hospital - Athens

    Athens

  • University General Hospital of Heraklion

    Heraklion, 71110

  • University Hospital of Ioannina Uhi

    Ioannina, 45500

  • Metropolitan Hospital

    Neo Faliro, 18547

  • Olympion Hospital

    Pátrai, 26443

  • Euromedica General Clinic of Thessaloniki

    Thessaloniki, 546 45

  • St. Luke's Hospital

    Thessaloniki

  • Bioclinic Thessaloniki (Galinos Clinic)

    Thessalonki, 54622

Other trials in Greece

South Korea9 sites

  • Chungbuk National University Hospital

    Cheongju-si, 28644

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

  • Samsung Medical Center

    Gangnam-Gu, 6351

  • National Cancer Center

    Goyang-si, 10408

  • Gyeongsang National University Hospital

    Jinju-si Gyeongsangnam-do, 52727

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Asan Medical Center

    Seoul, 05505

  • Yonsei University Health System - Severance Hospital

    Seoul, 3722

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

    Seoul, 6591

Other trials in South Korea

Taiwan9 sites

  • Changhua Christian Hospital

    Changhua, 500

  • China Medical University Hospital

    Hsia

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 10055

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, 112

  • Taipei Veterans General Hospital

    Taipei, 112

  • Tri-Service General Hospital

    Taipei, 11490

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 333

Other trials in Taiwan

Turkey (Türkiye)8 sites

  • Ankara Bilkent City Hospital

    Ankara, 6800

  • Akdeniz University Hospital

    Antalya, 7070

  • Medipol Mega University Hospital

    Bağcılar, 34214

  • Ege Universitesi Gogus Hastaliklari Poliklinigi

    Bornova-Izmir

  • Memorial Ankara Hospital

    Cankaya/Ankara, 6520

  • Medical Park Seyhan Hospital

    Etimesgut Ankara, 6790

  • Istanbul Medeniyet University Medical Faculty

    Istanbul, 34093

  • Adana Acibadem Hospital

    Seyhan

Other trials in Turkey (Türkiye)

Italy7 sites

  • Istituto Di Candiolo Irccs

    Candiolo, 10060

  • Ospedale San Luca

    Lucca

  • Azienda Ospedaliero - Universitaria San Luigi Gonzaga

    Orbassano, 10043

  • IFO Regina Elena

    Rome

  • Ospedale S. Maria Della Misericordia

    Udine, 33100

  • Asst Sette Laghi

    Varese, 21100

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

    Verona, 37134

Other trials in Italy

Australia6 sites

  • CRSA/ St Andrews Hospital

    Adelaide, 5000

  • Flinders Medical Centre (Fmc)

    Bedford Park, 5042

  • PSEHOG (Peninsula and South Eastern Haematology and Oncology Group)

    Frankston, 3199

  • St George Public Hospital

    Kogarah, 2217

  • Southern Medical Day Care Centre

    Wollongong, 2500

  • Princess Alexandra Hospital

    Woolloongabba, QLD 4102

Other trials in Australia

Chile6 sites

  • ONCOVIDA

    Santiago, 7500000

  • Centro de Estudios Clinicos Saga Spa

    Santiago, 7500653

  • Orlandi Oncologia

    Santiago, 7500713

  • Fundacion Arturo Lopez Perez

    Santiago

  • Centro de Investigaciones Clinicas Vina Del Mar

    ViĂąa Del Mar, 254-0488

  • Oncocentro Apys

    Viña del Mar

Other trials in Chile

Hungary6 sites

  • National Koranyi Institute For Pulmonology

    Budapest, 1121

  • Veszprem Megyei Tudogyogyintezet Farkasgyepu

    Farkasgyepű, 8582

  • Bkmk Hospital

    KecskemĂŠt, 6000

  • Fejer Megyei Szent Gyorgy Korhaz Pulmonologiai Osztaly

    Székesfehérvár, 8000

  • Hetenyi G Korhaz, Onkologiai Kozpont

    Szolnok, 5007

  • Reformatus Pulmonologiai Centrum

    Törökbálint

Other trials in Hungary

Poland6 sites

  • II Klinika Chorob Pluc i Gruzlicy

    Bialystok, 15-540

  • Centrum Terapii Wspolczesnej

    Lodz, 90-338

  • Instytut Centrum Zdrowia Matki Polki (Iczmp)

    Lodz, 93-338

  • SPSK4, Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

    Lublin, 20-954

  • Med Polonia Sp. Z O.O.

    Poznan, 60-693

  • Maria Sklodowska-Curie National Research Institute of Oncology

    Warsaw, 02-778

Other trials in Poland

Thailand6 sites

  • Faculty of Medicine Chulalongkorn University

    Bangkok, 10330

  • Ramathibodi Hospital

    Bangkok, 10400

  • Siriraj Hospital

    Bangkok, 10700

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

    Chiang Mai, 50200

  • Prince of Songkla University PSU - Faculty of Medicine

    Hat Yai, 90110

  • Khon Kaen University - Faculty of Medicine-Srinagarind Hospital

    Nonthaburi, 40002

Other trials in Thailand

Belgium5 sites

  • Az Maria Middelares - Campus Maria Middelares

    Ghent, 9000

  • Centre hospitalier Jolimont-Lobbes

    Haine-Saint-Paul

  • Jessa Hospital

    Hasselt, 3500

  • Cliniques Saint Pierre Ottignies (CSPO)

    Ottignies

  • Az Nikolaas

    Sint-Niklaas, 9100

Other trials in Belgium

Mexico5 sites

  • Cryptex Investigacion Clinica Sa de Cv

    Cuauhtémoc

  • Hospital Civil de Guadalajara Fray Antonio Alcalde

    Guadalajara

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

    Mexico City

  • Instituto Nacional de Cancerologia

    Mexico City

  • Centro de Investigacion Clinica de Oaxaca CICLO

    Oaxaca City

Other trials in Mexico

Romania5 sites

  • Institute of Oncology Prof. Dr. Ion Chiricuta

    Cluj-Napoca, 400015

  • Onco Clinic Consult Sa

    Craiova, 200094

  • Centrul de Oncologie Sfantu Nectarie

    Craiova, 200745

  • SC Oncomed SRL

    Jud Timis

  • Oncocenter Oncologie Clinica S.R.L

    Timișoara, 300166

Other trials in Romania

Portugal4 sites

  • Fundacao Champalimaud

    Lisbon, 1400-038

  • Hospital da Luz

    Lisbon, 1500-650

  • IPO Porto Francisco Gentil, E.P.E.

    Porto, 4150-001

  • Hospital CUF Porto

    Porto

Other trials in Portugal

Austria3 sites

  • Landeskrankenhaus Feldkirch

    Feldkirch, 6800

  • Klinikum Klagenfurt Pulmologie

    Klagenfurt, 9020

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

    Vienna, 1210

Other trials in Austria

Czechia3 sites

  • FN Brno Klinika Nemoci Plicnich a TBC

    Brno, 63500

  • Vseobecna Fakultni Nemocnice VFN

    Brno, 63500

  • Fakultni nemocnice Olomouc FNOL

    Olomouc, 779 00

Other trials in Czechia

Hong Kong3 sites

  • Tuen Mun Hospital

    Hong Kong, 999077

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

    Hong Kong, 99999

  • Queen Mary Hospital

    Pok Fu Lam, 999077

Other trials in Hong Kong

Netherlands3 sites

  • Jeroen Bosch Ziekenhuis Jbz

    's-Hertogenbosch, 5200 ME

  • Amphia Ziekenhuis

    Breda, 4819 EV

  • Leiden University Medical Center

    Leiden, 2333ZA

Other trials in Netherlands

Switzerland3 sites

  • Kantonsspital Baselland

    Liestal, 4410

  • Kantonsspital St. Gallen

    Sankt Gallen, 9007

  • Spital Sts Ag

    Thun, 3600

Other trials in Switzerland

Canada1 site

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

    Québec, G1J 1Z4

Other trials in Canada

United Kingdom1 site

  • Barts Health NHS Trust

    London, EC1A 7BE

Other trials in United Kingdom

About this study

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)

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).

Read the detailed description

The primary objectives of the study are Progression Free Survival (PFS) and Overall Survival (OS) as first line therapy in participants with programmed death-ligand 1 (PD-L1) TPS <50% and advanced or metastatic NSCLC without actionable genomic alternations, as well as participants who are TROP2 NMR+ at baseline. TROP2 NMR will be retrospectively assessed.

Eligible participants will be randomized in a 1:1:1 ratio to a) Dato-DXd plus pembrolizumab plus platinum; b) Dato-DXd plus pembrolizumab; or c) pembrolizumab plus pemetrexed plus platinum. Platinum therapy will be either carboplatin or cisplatin at investigator discretion. The study will be divided into three periods: Screening Period (including tissue screening), Treatment Period, and Follow-up Period.

Being tested
Datopotamab Deruxtecan, Pembrolizumab, Pemetrexed, Carboplatin, Cisplatin
Keywords
Metastatic Non Small Cell Lung Cancer, Advanced Non Small Cell Lung Cancer, Datopotamab Deruxtecan (Dato-DXd), Pembrolizumab, Pemetrexed, Tropion-Lung07
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

    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.

  • PemetrexedDrug

    Also called Alimta, Pemfexy

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

  • CarboplatinDrug

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

  • CisplatinDrug

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

Study groups in NCT05555732
Study groupRoleWhat they receive
Dato-DXd + Pembrolizumab + Platinum ChemotherapyExperimentalParticipants will be randomized to receive 6.0mg/kg Dato-DXd plus 200 mg pembrolizumab plus platinum chemotherapy (cisplatin 75 mg/m^2 or carboplatin area under the curve [AUC) 5]).
Receives: Drug: Datopotamab Deruxtecan; Drug: Pembrolizumab; Drug: Carboplatin; Drug: Cisplatin
Dato-DXd + PembrolizumabExperimentalParticipants will be randomized to receive 6.0mg/kg Dato-DXd plus 200 mg pembrolizumab.
Receives: Drug: Datopotamab Deruxtecan; Drug: Pembrolizumab
Pembrolizumab + Pemetrexed + Platinum ChemotherapyActive comparatorParticipants will be randomized to receive 200 mg pembrolizumab plus 500 mg/m^2 pemetrexed plus platinum chemotherapy (cisplatin 75 mg/m^2 or carboplatin area under the curve [AUC) 5]).
Receives: Drug: Pembrolizumab; Drug: Pemetrexed; Drug: Carboplatin; Drug: Cisplatin

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 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 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 43 months

  2. Progression-free Survival Based on Blinded Independent Central Review in All Randomized Participants who are TROP2 NMR positive

    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 43 months

  3. Overall Survival in All Randomized Participants

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

    Measured: From randomization until disease progression or death (whichever occurs first), up to approximately 76 months

  4. Overall Survival in All Randomized Participants who are TROP2 NMR positive

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

    Measured: From randomization until disease progression or death (whichever occurs first), up to approximately 76 months

Secondary outcomes (11)

  1. Objective Response Rate by Blinded Independent Central Review in All Randomized Participants

    Objective Response Rate (ORR) is defined as the proportion of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), assessed by BICR per RECIST Version 1.1.

    Measured: From randomization until disease progression or death (whichever occurs first), up to approximately 43 months

  2. Objective Response Rate by Blinded Independent Central Review in All Randomized Participants who are TROP2 NMR positive

    Objective Response Rate (ORR) is defined as the proportion of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), assessed by BICR per RECIST Version 1.1.

    Measured: From randomization until disease progression or death (whichever occurs first), up to approximately 43 months

  3. Progression-free Survival by Investigator in Both All Randomized Participants and Randomized Participants who are TROP2 NMR positive

    Progression-free Survival (PFS) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by the Investigator per RECIST Version 1.1.

    Measured: From randomization until disease progression or death (whichever occurs first), up to approximately 43 months

  4. Objective Response Rate by Investigator in Both All Randomized Participants and Randomized Participants who are TROP2 NMR positive

    Objective Response Rate (ORR) is defined as the proportion of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), assessed by the Investigator per RECIST Version 1.1.

    Measured: From randomization until disease progression or death (whichever occurs first), up to approximately 43 months

  5. Duration of Response by BICR and Investigator in Both All Randomized Participants and Randomized Participants who are TROP2 NMR positive

    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 43 months

  6. Time to Response by BICR and Investigator in Both All Randomized Participants and Randomized Participants who are TROP2 NMR positive

    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 43 months

  7. Disease Control Rate by BICR and Investigator in Both All Randomized Participants and Randomized Participants who are TROP2 NMR positive

    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 43 months

  8. Progression-free Survival 2 in Both All Randomized Participants and Randomized Participants who are TROP2 NMR positive

    Progression-free Survival 2 (PFS2) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by local standard clinical practice

    Measured: From randomization until disease progression or death (whichever occurs first), up to approximately 76 months

  9. Time to Deterioration

    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 until disease progression or death (whichever occurs first), up to approximately 76 months

  10. Number of Participants With Treatment-emergent Adverse Events (TEAE)

    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 76 months

  11. Proportion of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) and Proportion of Participants Who Have Treatment-emergent ADA

    The immunogenicity of Dato-DXd in combination with pembrolizumab will be assessed.

    Measured: Baseline and up to 76 months

Timeline

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

  1. First posted27 Sep 2022
  2. Study start11 Jan 2023
  3. Primary completion11 May 2029 (estimated)
  4. Study completion11 May 2031 (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
1,170 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05555732
Sponsor's protocol ID
DS1062-A-U303
Other IDs
2022-500802-16-00, MK-3475-E10, jRCT2061220066, TROPION-Lung07, KEYNOTE-E10
Status last verified
Jun 2026
First submitted
22 Sep 2022
Last updated
23 Jun 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

  • Okamoto I, Kuyama S, Girard N, Lu S, Franke F, Li Z, Danchaivijitr P, Han JY, Sun JM, Sugawara S, Pan E, Ren N, Chen A, Rajagopalan R, Lisberg AE. TROPION-Lung07: Phase III study of Dato-DXd + pembrolizumab +/- platinum-based chemotherapy as 1L therapy for advanced non-small-cell lung cancer. Future Oncol. 2024;20(37):2927-2936. doi: 10.1080/14796694.2024.2409621. Epub 2024 Oct 29.

    PubMed 39469838

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Datopotamab Deruxtecan, Pembrolizumab and Pemetrexed in people with Metastatic Non Small Cell Lung Cancer, run by Daiichi Sankyo at 260 sites in 29 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 6 inclusion and 19 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 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 260 sites in United States, China, Japan, France, Spain and 24 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 All Randomized Participants (time frame: From randomization until disease progression or death (whichever occurs first), up to approximately 43 months). The study lists 4 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 NCT05555732, 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 23 Jun 2026.

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