AzTrials
AzTrials

Non-small Cell Lung CancerPhase 3NCT04656652

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

A Phase 3 study testing DS-1062a and Docetaxel in people with Non-small Cell Lung Cancer, run by Daiichi Sankyo at 209 sites in 26 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 will evaluate the efficacy, safety, and pharmacokinetics of DS-1062a versus docetaxel in participants with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) with or without actionable genomic alterations. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
DS-1062a and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
605 participants
Where
209 sitesin 26 countries
Study dates
21 Dec 2020to 15 Feb 2027
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 inform consent form (ICF) prior to the start of any study specific qualification procedures.
  • Adults ≥18 years (if the legal age of consent is >18 years old, then follow local regulatory requirements)
  • Life expectancy ≥3 months
  • Has pathologically documented Stage IIIB, IIIC, or stage IV NSCLC disease with or without actionable genomic alterations (AGA) at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition) and meets following criteria for NSCLC:
  • Participants without AGA:
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  • Must have documented negative test results for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK).
  • Must have no known genomic alterations in ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), proto oncogene B-raf (BRAF), mesenchymal-epithelial transition (MET) exon 14 skipping, or rearranged during transfection (RET).
  • Participants with AGA must have one or more documented actionable genomic alteration(s): EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, or RET.
  • Has documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC.
  • Participant without AGA must meet 1 of the following prior therapy requirements for advanced or metastatic NSCLC:
  • Received platinum-based chemotherapy in combination with α-PD-1/α-PD-L1 monoclonal antibody as the only prior line of therapy.
  • Includes participants who received prior platinum-based/chemotherapy with or without radiotherapy with maintenance α-PD-1/α-PD-L1 monoclonal antibody for Stage III disease and relapsed/progressed within 6 months from the last dose of platinum-based chemotherapy.
  • Includes participants who received prior platinum-based/chemotherapy with or without radiotherapy (with or without maintenance α-PD-1/α-PD-L1 monoclonal antibody) for Stage III disease and subsequently received α-PD-1/α-PD-L1 monoclonal antibody therapy (with or without platinum-based chemotherapy) for recurrent disease.
  • Received platinum-based chemotherapy and α-PD-1/α-PD-L1 monoclonal antibody (in either order) sequentially as the only 2 prior lines of therapy.
  • Participants with AGA must meet the following for advanced or metastatic NSCLC:
  • Participants who have been treated with 1 or 2 prior lines of applicable targeted therapy that is locally approved for the participant's genomic alteration at the time of screening;
  • Participants who have tumors with EGFR L858R or exon 19 deletion mutations must have received prior Osimertinib.
  • Those who received a targeted agent as adjuvant therapy for early-stage disease must have relapsed or progressed while on the treatment or within 6 months of the last dose OR received at least one additional course of targeted therapy for the same genomic alteration (which may or may not be same agent used in the adjuvant setting) for relapsed/progressive disease.
  • Participants who have been treated with a prior tyrosine kinase inhibitor (TKI ) must receive additional approved targeted therapy, if locally available and clinically appropriate, for the applicable genomic alteration, or the participant will not be allowed in the study.
  • Participants who have received platinum-based chemotherapy as the only prior line of cytotoxic therapy:
  • One platinum-containing regimen for advanced disease
  • Those who received a platinum-containing regimen as adjuvant therapy for early-stage disease must have relapsed or progressed while on the treatment or within 6 months of the last dose OR received at least one additional course of platinum-containing therapy (which may or may not be same as in the adjuvant setting) for relapsed/progressive disease.
  • May have received up to one α-PD-1/α-PD-L1 monoclonal antibody alone or in combination with a cytotoxic agent.
  • Must undergo a pre-treatment tumor biopsy procedure or if available, tumor tissue previously retrieved from a biopsy procedure performed within 2 years prior to the participant signing informed consent and that has a minimum of 10 × 4 micron sections or a tissue block equivalent of 10 × 4 micron sections may be substituted for the pre-treatment biopsy procedure during Screening. If a documented law or regulation prohibits (or does not approve) sample collection, then such samples will not be collected/submitted
  • Measurable disease based on local imaging assessment using RECIST v1.1
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at Screening
  • Within 7 days before randomization, has adequate bone marrow, hepatic, and renal function
  • Left ventricular ejection fraction (LVEF) ≥50% by either echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before randomization
  • Adequate blood clotting function defined as international normalized ratio/prothrombin time and either partial thromboplastin or activated partial thromboplastin time ≤1.5 × upper limit of normal (ULN)
  • Adequate treatment washout period before randomization
  • Females of childbearing potential must have a negative serum pregnancy test at screening and must be willing to use highly effective birth control from the time of enrollment up to 7 months after the last dose of DS-1062a or for at least 6 months after the last dose of docetaxel
  • Males must be surgically sterile or must use a condom in addition to highly effective birth control if his partners are of reproductive potential from the time of enrollment and for at least 4 months after last dose of DS-1062a or for at least 6 months after the last dose of docetaxel
  • Male participants must not freeze or donate sperm from the time of Screening and throughout the study period and for at least 4 months after the last dose of DS-1062a or for at least 6 months after the last dose of docetaxel
  • Female participants must not donate, or retrieve for their own use, ova from the time of Screening and throughout the study period and for at least 7 months after the last dose of DS-1062a and for at least 6 months after the last dose of docetaxel

Who cannot join

  • Mixed small-cell lung cancer (SCLC) and NSCLC histology
  • Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Participants with clinically inactive brain metastases may be included in the study. Participants with treated brain metastases who are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy.
  • Has leptomeningeal carcinomatosis or metastasis
  • Had prior treatment with:
  • Any agent including antibody drug conjugate (ADC) containing a chemotherapeutic agent targeting topoisomerase I
  • TROP2-targeted therapy
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  • Docetaxel
  • Had prior treatment with platinum-based chemotherapy and prior immunotherapy for Stage II NSCLC disease (eg, in the neo-adjuvant or adjuvant setting) without subsequently meeting the prior therapy requirements for Stage III or metastatic NSCLC disease
  • Has NSCLC disease that is eligible for definitive local therapy alone
  • Has uncontrolled or significant cardiac disease, including:
  • Mean QT interval corrected for heart rate using Fridericia's formula >470 msec (based on the average of Screening triplicate 12-lead electrocardiogram [ECG] determinations).
  • Myocardial infarction or uncontrolled/unstable angina within 6 months before randomization
  • Congestive heart failure (CHF) (New York Heart Association Class II to IV) at Screening. Participants 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 or significant cardiac arrhythmia
  • LVEF <50% by ECHO or MUGA scan within 28 days before randomization
  • Uncontrolled hypertension (resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) within 28 days before randomization
  • Has a history of (non-infectious) interstitial lung disease (ILD)/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 resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months before randomization, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.), or any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or prior pneumonectomy.
  • Significant third-space fluid retention (for example ascites or pleural effusion) and is not amenable for required repeated drainage
  • Clinically significant corneal disease
  • Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals; suspected infections (eg, prodromal symptoms); or inability to rule out infections
  • Has known human immunodeficiency virus (HIV) infection that is not well controlled
  • Has an active or uncontrolled hepatitis B and/or hepatitis C infection, is positive for hepatitis B or C virus based on the evaluation of results of tests for hepatitis B (hepatitis B surface antigen [HBsAg], anti-hepatitis B surface antibody [anti-HBs], anti-hepatitis B core antibody [anti-HBc], or hepatitis B virus [HBV] DNA), and/or hepatitis C infection (as per hepatitis C virus [HCV] RNA) within 28 days of randomization.
  • Has a history of malignancy, other than NSCLC, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ≥3 years
  • Toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet improved to NCI-CTCAE version 5.0 Grade ≤1 or baseline
  • Has a history of severe hypersensitivity reactions to either the drug substances, inactive ingredients (including but not limited to polysorbate 80) of DS-1062a or docetaxel, or monoclonal antibodies
  • Pregnant or breastfeeding
  • Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions

Trial locations and contacts

209 sites in 26 countries.

209 sites in 26 countries

United States32 sites

  • St. Joseph Heritage Healthcare

    Anaheim, California, 92835

  • Messino Cancer Centers

    Asheville, North Carolina, 28806

  • Baton Rouge General

    Baton Rouge, Louisiana, 70809

  • American Oncology Partners of Maryland

    Bethesda, Maryland, 20817

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Ironwood Cancer and Research Center

    Chandler, Arizona, 85224

  • University of Virginia Health System

    Charlottesville, Virginia, 22903

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Chicago

    Chicago, Illinois, 60637

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Virginia Cancer Specialist

    Fairfax, Virginia, 22031

  • Ft. Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46804

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104

  • The Oncology Institute of Hope and Innovation

    Glendale, California, 91204

  • Memorial Healthcare System- Memorial Cancer Institute

    Hollywood, Florida, 33021

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336

  • University of California San Diego

    La Jolla, California, 92093

  • OptumCare Cancer Care

    Las Vegas, Nevada, 89106

  • UCLA

    Los Angeles, California, 90095

  • Baptist Health Louisville

    Louisville, Kentucky, 40207

  • Meridian Hematology and Oncology

    Manahawkin, New Jersey, 08050

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Orlando Health

    Orlando, Florida, 32806

  • Roger Williams Medical Center

    Providence, Rhode Island, 02908

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Astera Cancer Care

    Somerset, New Jersey, 08873

  • Northwest Medical Specialties

    Tacoma, Washington, 98405

  • Florida Cancer Specialists

    Tallahassee, Florida, 32308

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • PIH Health

    Whittier, California, 90602

Other trials in United States

Japan21 sites

  • Hyogo Cancer Center

    Akashi, 673-8558

  • Niigata Cancer Center Hospital

    Chūōku, 951-8566

  • Kyushu University Hospital

    Fukuoka, 812-8582

  • Saitama Medical University International Medical Center

    Hidaka, 350-1298

  • Kansai Medical University Hospital

    Hirakata, 573-1191

  • Kanazawa University Hospital

    Kanazawa, 920-8641

  • National Cancer Center Hospital East

    Kashiwa, 277-8577

  • The Cancer Institute Hospital of JFCR

    Kōtoku, 135-8550

  • Kyoto University Hospital

    Kyoto, 606-8507

  • NHO Shikoku Cancer Center

    Matsuyama, 791-0280

  • Shizuoka Cancer Center

    Nagaizumi-chō, 411-8777

  • Okayama University Hospital

    Okayama, 36927

  • Osaka City General Hospital

    Osaka, 534-0021

  • Osaka International Cancer Institute

    Osaka, 541-8567

  • Kindai University Hospital

    Ōsaka-sayama, 589-8511

  • Saitama Cancer Center

    Saitama, 362-0806

  • Sendai Kousei Hospital

    Sendai, 980-0873

  • NHO Hokkaido Cancer Center

    Shiroishi, 003-0804

  • Tokushima University Hospital

    Tokushima, 770-8503

  • National Cancer Center Hospital

    Tokyo, 104-0045

  • Fujita Health University Hospital

    Toyoake, 470-1192

Other trials in Japan

China19 sites

  • Beijing Cancer Hospital

    Beijing, 100142

  • Hunan Cancer Hospital

    Changsha

  • Xiangya Hospital central south university

    Changsha

  • Linyi Cancer Hospital

    Hangzhou, 310003

  • The First Affiliated Hospital of Zhejiang University

    Hangzou, 310022

  • Harbin Medical University Cancer Hospital

    Heilongjiang, 150081

  • Jiamusi Cancer Tuberculosis Hospital

    Heilongjiang, 154007

  • Fudan University Shanghai Cancer Center

    Henan, 450008

  • Hubei Cancer Hospital

    Hubei, 430079

  • Jiangsu Province Hospital

    Nanjing

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Shandong, 276000

  • Shanghai Chest Hospital

    Shanghai

  • Henan Cancer Hospital

    Shanghai Sheng, 200032

  • Zhejiang Cancer Hospital

    Shanxi, 710061

  • West China Hospital, Sichuan University

    Sichuan Province

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, 300060

  • Affiliated Cancer Hospital of Xinjiang Medical University

    Ürümqi

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

    Wuhan, 43002

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Zhejiang, 310016

Other trials in China

France13 sites

  • Hopital Jean Minjoz

    Besançon, 25030

  • Centre Hospitalier Universitaire de Grenoble

    Grenoble, 38043

  • Centre Leon Berard

    Lyon, 69008

  • CHU Louis Pradel

    Lyon

  • APHM - Hopital Nord

    Marseille, 13915

  • University Hospital of Nantes - Thoracic Oncology

    Nantes, 44000

  • Institut Curie

    Paris, 75248

  • CHU de Poitier Pole regional de Cancerologie

    Poitiers, 86000

  • Hopital Pontchaillou

    Rennes, 35000

  • Hopitaux Universitaire de Strasbourg

    Strasbourg, 67098

  • Hopital Foch

    Sureesnes, 92150

  • CHU Toulouse Hopital Larrey

    Toulouse, 31059

  • Gustav Roussy Cancer Campus Grand Paris

    Villejuif, 94805

Other trials in France

Spain13 sites

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036

  • Hospital Universitario Vall d'Hebron

    Barcelona, 80350

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Puerte de Hierro de Majadahonda

    Madrid, 28222

  • Hospital Regional Universitario Málaga

    Málaga, 29010

  • CHUO

    Ourense, 32005

  • Hospital Virgen Macarena

    Seville, 41007

  • Hospital Universitario de Valme

    Seville, 41014

  • Hospital General Universitario de Valencia

    Valencia, 46014

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

  • Hospital Clinico Universitario Lozano Bleza

    Zaragoza, 50009

Other trials in Spain

Germany11 sites

  • Charite - Universitaetsmedizin Berlin

    Berlin, 10117

  • Evangelische Lungenklinik Berlin

    Berlin, 13125

  • Universitaet zu Koeln - Uniklinik Koeln

    Cologne, 50937

  • IKF Krankenhaus Nordwest

    Frankfurt am Main, 60488

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Asklepios Fachklinik Muenchen-Gauting

    Gauting, 82131

  • Thoraxklinik Heidelberg gGmbH

    Heidelberg, 69126

  • Lungenklinik Hemer

    Hemer, 58675

  • Klinikverbund Allgäu

    Kempten, 87439

  • Medizinische Klinik V

    Standort Gießen

  • Klinikum Traunstein

    Traunstein

Other trials in Germany

South Korea10 sites

  • Chungbuk National University Hospital

    Cheongju-si, 28644

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

  • St. Vincents Hospital The Catholic University of Korea

    Gyeonggi-do, 16247

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Yonsei University Health System - Severance Hospital

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

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

    Seoul, 06591

  • Seoul National University Boramae Medical Center

    Seoul, 07061

Other trials in South Korea

Italy9 sites

  • Azienda Ospedaliero- Universitaria Policlinico S. Orsola-Malpighi

    Bologna, 40138

  • Azienda Ospedaliera Universitaria Policlinico G Rodolico San Marco

    Catania, 95030

  • ASL 3 Genovese Oncologia Medica Villa Scassi

    Genova, 16149

  • Fondazione IRCCS Istituto Nazionale Tumori

    Milan, 20133

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • IRCCS Istituto Europeo di Oncologia

    Milan, 20141

  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga

    Orbassano, 10043

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168

  • Instituicao de Fisioterapeutas Ocupacionais

    Roma, RM00144

Other trials in Italy

Poland9 sites

  • II Klinika Chorob Pluc i Gruzlicy

    Bialystok, 15-276

  • Szpitale Pomorskie Sp.zo.o

    Gdynia, 81-519

  • Ms Pneumed

    Lublin, 20-090

  • SP Zespol Gruzlicy i Chorob Pluc

    Olsztyn, 10-357

  • Med Polonia Sp. z o.o.

    Poznan, 60-693

  • Szpital Specjalistyczny w Prabutach Sp. z o.o.

    Prabuty, 82-550

  • Oddział Onkologii Wojewódzki Szpital Specjalistyczny Słupsk

    Słupsk, 76-200

  • Magodent Sp. z.o.o Szpital Elblaska

    Warsaw, 01-748

  • Maria Sklodowska-Curie National Research Institute of Oncology

    Warsaw, 02-781

Other trials in Poland

Romania8 sites

  • SC Oncopremium Team SRL

    Baia Mare, 430291

  • Institutul Oncologic Profesor Doctor Alexandru Trestioreanu

    Bucharest, 022328

  • Centrul Medical Sanador

    Bucharest, 20125

  • Clinical Emergency Hospital

    Constanța, 900591

  • Onco Clinic Consult SA

    Craiova, 200103

  • Sf Nectarie Oncology Center

    Craiova, 200347

  • Oncolab SRL

    Craiova, 200385

  • SC Oncomed SRL

    Timișoara, 300425

Other trials in Romania

Taiwan8 sites

  • E-Da Hospital

    Kaohsiung City, 00824

  • Chang Gung Memorial Hospital CGMH - Kaohsiung Branch

    Niaosong, 00833

  • Chung Shan Medical University Hospital

    Taichung, 00420

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Cheng Kung University Hospital NCKUH

    Tainan, 00704

  • Chi Mei Medical Center CMMC - Liouying Branch

    Tainan, 00736

  • National Taiwan University Hospital NTUH

    Taipei, 00100

  • LinKou Chang Gung Memorial Hospital

    Taoyuan, 333

Other trials in Taiwan

Russia7 sites

  • Kursk Regional Clinical Oncology Dispensary

    Kursk, 305524

  • Federal State Budgetary Institution - N.N. Blokhin National Medical Research Center of Oncology

    Moscow, 115478

  • University Headache Clinic LLC

    Moscow, 121467

  • VitaMed LLC

    Moscow, 129515

  • Institute of Oncology Hadassah Moscow

    Moscow

  • LLC MSCH "Klinitsist"

    Novosibirsk, 630099

  • N.N. Petrov Research Institute of Oncology

    Saint Petersburg, 197758

Other trials in Russia

Australia6 sites

  • Flinders Medical Centre

    Bedford Park, 05042

  • Blacktown Hosital

    Blacktown, 02148

  • Austin Hospital

    Heidelberg, 03084

  • Macquarie Hospital

    North Ryde, 02109

  • Crown Princess Mary Cancer Centre Westmead Hospital

    Sydney, 2145

  • Southern Medical Day Care Centre

    Wollongong, 02500

Other trials in Australia

Brazil5 sites

  • Instituto do Cancer do Ceara - ICC

    Fortaleza, 60430-230

  • Hospital Sao Lucas da Pucrs

    Porto Alegre, 90610-000

  • Hospital Nossa Senhora da Conceição

    Porto Alegre, 91350-200

  • Instituto Nacional de Cancer-INCA

    Rio de Janeiro, 20231-050

  • Hospital de Base de Sao Jose do Rio Preto

    São José do Rio Preto, 15090-000

Other trials in Brazil

Hungary5 sites

  • Orszagos Koranyi TBC es Pulmonologiai Intezet

    Budapest, 01121

  • Uzsoki Utcai Korhaz

    Budapest, 1145

  • Szent Borbala Korhaz

    Tatabánya, 02800

  • Tolna Megyei Balassa Janos Korhaz

    Tolna

  • Tudogyogyintezet Torokbalint

    Törökbálint, H-2045

Other trials in Hungary

Argentina4 sites

  • CER San Juan

    Buenos Aires, 01878

  • Centro de Investigacion Pergamino S.A.

    Pergamino, B2700CPM

  • Instituto de OncologÃÂ-a de Rosario

    Rosario, S2000KZE

  • Gaston Martinengo

    Rosario, S2000

Other trials in Argentina

Belgium4 sites

  • Centre Hospitalier Jolimont-Lobbes

    Haine-Saint-Paul, 07100

  • CHA Centre Hospitalier de l Ardenne

    Libramont, B-6800

  • CHR site de la Citadelle

    Liège, 04000

  • CHU UCL Namur

    Yvoir, 05530

Other trials in Belgium

Canada4 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • MUHC-Glen Site and MUHC Research Institute

    Montreal, Quebec, H4A 3J1

  • University Health Network - Princess Margaret Hospital

    Toronto, Ontario, M5G0A3

  • Sunnbrook Health Sciences Centre

    Toronto, Ontario, ON M4N 3M5

Other trials in Canada

Mexico4 sites

  • San Peregrino Cancer Center

    Aguascalientes, 20230

  • Hospital Civil de Guadalajara Fray Antonio Alcalde

    Guadalajara, 44280

  • Hospital Medica Sur Tlalpan

    Mexico City, 14050

  • Hospital Universitario Jose Eleuterio Gonzalez

    Monterrey, 64460

Other trials in Mexico

Netherlands4 sites

  • Erasmus MC

    Amsterdam, 3000 CA

  • Amphia Ziekenhuis

    Breda, 4818 CK

  • Isala Klinieken

    Harderwijk, 3844 DG

  • St. Jansdal Ziekenhuis

    Rotterdam, 3015 CD

Other trials in Netherlands

Singapore3 sites

  • National Cancer Centre Singapore

    Singapore, 169610

  • ICON Cancer Centre Farrer Park Hospital

    Singapore, 217562

  • OncoCare Cancer Centre - Gleneagles Medical Centre Location

    Singapore, 258499

Other trials in Singapore

Switzerland3 sites

  • Inselspital Universitätsspital Bern

    Bern, 3010

  • Kantonsspital St. Gallen

    Sankt Gallen, 9007

  • Stadtspital Waid ; Triemli, Site Triemli - clinic for Medical oncology &amp; hematology

    Zurich, 8063

Other trials in Switzerland

United Kingdom3 sites

  • University College Hospital

    London, NW1 2BU

  • The Christie Hospital

    Manchester, M20 4BX

  • The James Cook University Hospital

    Middlesbrough, TS4 3BW

Other trials in United Kingdom

Hong Kong2 sites

  • Queen Mary Hospital

    Hong Kong, 999077

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

    Hong Kong, 99999

Other trials in Hong Kong

Czechia1 site

  • Vseobecna Fakultni Nemocnice VFN

    Prague, 12800

Other trials in Czechia

Puerto Rico1 site

  • FDI Clinical Research

    San Juan, 00927

Other trials in Puerto Rico

About this study

Official title: Phase 3 Randomized Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-LUNG01)

This study will evaluate the efficacy, safety, and pharmacokinetics of DS-1062a versus docetaxel in participants with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) with or without actionable genomic alterations.

Read the detailed description

This study will evaluate DS-1062a 6.0 mg/kg vs docetaxel 75 mg/m^2 in participants with advanced or metastatic NSCLC with or without actionable genomic alterations (AGAs). Participants without actionable genomic alterations must have been previously treated with platinum-based chemotherapy and α (anti)-programmed cell death 1 (PD-1)/α-programmed cell death ligand 1 (PD-L1) monoclonal antibody, either in combination or sequentially. Participants with AGA must have progressed on or after 1 platinum-containing therapy and 1 to 2 prior lines of approved targeted therapy for the applicable genomic alteration. The study will be divided into 3 periods: Screening Period, Treatment Period, and Follow-up Period.

Being tested
DS-1062a, Docetaxel
Keywords
Metastatic Non-small Cell Lung Cancer, Advanced Non-small Cell Lung Cancer, Non-small Cell Lung Cancer, DS-1062, Docetaxel, Datopotamab Deruxtecan (Dato-DXd)
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.

  • DS-1062aDrug

    Also called Datopotamab deruxtecan (Dato-DXd)

    DS-1062a will be administered as an intravenous (IV) infusion on Day 1 of each 3-week cycle

  • DocetaxelDrug

    Docetaxel will be administered as an IV infusion on Day 1 of each 3-week cycle.

Study groups in NCT04656652
Study groupRoleWhat they receive
DS-1062a 6.0 mg/kgExperimentalParticipants will be randomized to receive 6.0 mg/kg of DS-1062a.
Receives: Drug: DS-1062a
Docetaxel 75 mg/m^2Active comparatorParticipants will be randomized to receive 75 mg/m^2 docetaxel.
Receives: Drug: Docetaxel

What is being measured

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

  1. Progression-free Survival (PFS) As Assessed by Blinded Independent Central Review (BICR) Per RECIST v1.1 Following DS-1062a Versus Docetaxel

    PFS is defined as the time from randomization to the earlier of the dates of the first documentation of radiographic progressive disease or death due to any cause.

    Measured: From randomization until disease progression or death (whichever occurs first), up to approximately 27 months

  2. Overall Survival (OS) Following DS-1062a Versus Docetaxel

    OS is defined as the time from randomization to the date of death due to any cause.

    Measured: From randomization until date of death due to any cause, up to to approximately 38 months

Secondary outcomes (3)

  1. Progression-free Survival (PFS) As Assessed by Investigator Per RECIST v1.1 Following DS-1062a Versus Docetaxel

    PFS is defined as the time from randomization to the earlier of the dates of the first documentation of radiographic progressive disease or death due to any cause.

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

  2. Objective Response Rate (ORR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel

    ORR is defined as the proportion of subjects who achieved a best overall response (BOR) of complete response (CR) or partial response (PR), as assessed by BICR and investigator per RECIST v1.1.

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

  3. Duration of Response (DOR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel

    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 documentation of radiographic Progressive Disease or death due to any cause, whichever occurs first.

    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

Timeline

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

  1. First posted7 Dec 2020
  2. Study start21 Dec 2020
  3. Primary completion10 May 2024
  4. Study completion15 Feb 2027 (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
605 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04656652
Sponsor's protocol ID
DS1062-A-U301
Other IDs
2020-004643-80, 2023-509865-19-00, 2023
Status last verified
Aug 2026
First submitted
19 Nov 2020
Last updated
26 Aug 2026
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

  • Sands J, Ahn MJ. Datopotamab deruxtecan versus docetaxel for non-small cell lung cancer: a plain language summary of the TROPION-Lung01 study. Future Oncol. 2026 Feb;22(3):271-284. doi: 10.1080/14796694.2025.2586004. Epub 2025 Nov 21.

    PubMed 41268710

  • Ahn MJ, Lisberg A, Goto Y, Sands J, Hong MH, Paz-Ares L, Pons-Tostivint E, Perol M, Felip E, Sugawara S, Hayashi H, Cho BC, Blumenschein G Jr, Shum E, Lee JS, Heist RS, Cornelissen R, Chang WC, Kowalski D, Zebger-Gong H, Chargualaf M, Gu W, Lan L, Howarth P, Joseph R, Okamoto I. A Pooled Analysis of Datopotamab Deruxtecan in Patients With EGFR-Mutated NSCLC. J Thorac Oncol. 2025 Nov;20(11):1669-1682. doi: 10.1016/j.jtho.2025.06.002. Epub 2025 Jun 12.

    PubMed 40516821

  • Ahn MJ, Tanaka K, Paz-Ares L, Cornelissen R, Girard N, Pons-Tostivint E, Vicente Baz D, Sugawara S, Cobo M, Perol M, Mascaux C, Poddubskaya E, Kitazono S, Hayashi H, Hong MH, Felip E, Hall R, Juan-Vidal O, Brungs D, Lu S, Garassino M, Chargualaf M, Zhang Y, Howarth P, Uema D, Lisberg A, Sands J; TROPION-Lung01 Trial Investigators. Datopotamab Deruxtecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III TROPION-Lung01 Study. J Clin Oncol. 2025 Jan 20;43(3):260-272. doi: 10.1200/JCO-24-01544. Epub 2024 Sep 9.

    PubMed 39250535

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DS-1062a and Docetaxel in people with Non-small Cell Lung Cancer, run by Daiichi Sankyo at 209 sites in 26 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 35 inclusion and 28 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 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 209 sites in United States, Japan, China, France, Spain and 21 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?

Yes. Results are posted in the registry (first posted 23 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (PFS) As Assessed by Blinded Independent Central Review (BICR) Per RECIST v1.1 Following DS-1062a Versus Docetaxel (time frame: From randomization until disease progression or death (whichever occurs first), up to approximately 27 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 NCT04656652, which also lists 3 linked publications.

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 26 Aug 2026.

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