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)
Phase 3 Randomized Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-LUNG01)
3 other identifiers
interventional
605
26 countries
209
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 nonsmall-cell-lung-cancer
Started Dec 2020
Typical duration for phase_3 nonsmall-cell-lung-cancer
209 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2020
CompletedFirst Posted
Study publicly available on registry
December 7, 2020
CompletedStudy Start
First participant enrolled
December 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2024
CompletedResults Posted
Study results publicly available
July 23, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2027
ExpectedMarch 24, 2026
March 1, 2026
3.4 years
November 19, 2020
May 7, 2025
March 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
From randomization until disease progression or death (whichever occurs first), up to approximately 27 months
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.
From randomization until date of death due to any cause, up to to approximately 38 months
Secondary Outcomes (3)
Progression-free Survival (PFS) As Assessed by Investigator Per RECIST v1.1 Following DS-1062a Versus Docetaxel
From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
Objective Response Rate (ORR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel
From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
Duration of Response (DOR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel
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
Study Arms (2)
DS-1062a 6.0 mg/kg
EXPERIMENTALParticipants will be randomized to receive 6.0 mg/kg of DS-1062a.
Docetaxel 75 mg/m^2
ACTIVE COMPARATORParticipants will be randomized to receive 75 mg/m\^2 docetaxel.
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- 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:
- +19 more criteria
You may not qualify if:
- 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
- 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
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
- AstraZenecacollaborator
Study Sites (209)
Ironwood Cancer and Research Center
Chandler, Arizona, 85224, United States
St. Joseph Heritage Healthcare
Anaheim, California, 92835, United States
The Oncology Institute of Hope and Innovation
Glendale, California, 91204, United States
University of California San Diego
La Jolla, California, 92093, United States
UCLA
Los Angeles, California, 90095, United States
PIH Health
Whittier, California, 90602, United States
Memorial Healthcare System- Memorial Cancer Institute
Hollywood, Florida, 33021, United States
Orlando Health
Orlando, Florida, 32806, United States
Florida Cancer Specialists
Tallahassee, Florida, 32308, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
Ft. Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804, United States
Baptist Health Louisville
Louisville, Kentucky, 40207, United States
Baton Rouge General
Baton Rouge, Louisiana, 70809, United States
American Oncology Partners of Maryland
Bethesda, Maryland, 20817, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
OptumCare Cancer Care
Las Vegas, Nevada, 89106, United States
Meridian Hematology and Oncology
Manahawkin, New Jersey, 08050, United States
Astera Cancer Care
Somerset, New Jersey, 08873, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Messino Cancer Centers
Asheville, North Carolina, 28806, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Roger Williams Medical Center
Providence, Rhode Island, 02908, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
University of Virginia Health System
Charlottesville, Virginia, 22903, United States
Virginia Cancer Specialist
Fairfax, Virginia, 22031, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336, United States
Northwest Medical Specialties
Tacoma, Washington, 98405, United States
CER San Juan
Buenos Aires, 01878, Argentina
Centro de Investigacion Pergamino S.A.
Pergamino, B2700CPM, Argentina
Instituto de OncologÃÂ-a de Rosario
Rosario, S2000KZE, Argentina
Gaston Martinengo
Rosario, S2000, Argentina
Flinders Medical Centre
Bedford Park, 05042, Australia
Blacktown Hosital
Blacktown, 02148, Australia
Austin Hospital
Heidelberg, 03084, Australia
Macquarie Hospital
North Ryde, 02109, Australia
Crown Princess Mary Cancer Centre Westmead Hospital
Sydney, 2145, Australia
Southern Medical Day Care Centre
Wollongong, 02500, Australia
Centre Hospitalier Jolimont-Lobbes
Haine-Saint-Paul, 07100, Belgium
CHA Centre Hospitalier de l Ardenne
Libramont, B-6800, Belgium
CHR site de la Citadelle
Liège, 04000, Belgium
CHU UCL Namur
Yvoir, 05530, Belgium
Instituto do Cancer do Ceara - ICC
Fortaleza, 60430-230, Brazil
Hospital Sao Lucas da Pucrs
Porto Alegre, 90610-000, Brazil
Hospital Nossa Senhora da Conceição
Porto Alegre, 91350-200, Brazil
Instituto Nacional de Cancer-INCA
Rio de Janeiro, 20231-050, Brazil
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, 15090-000, Brazil
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
University Health Network - Princess Margaret Hospital
Toronto, Ontario, M5G0A3, Canada
Sunnbrook Health Sciences Centre
Toronto, Ontario, ON M4N 3M5, Canada
MUHC-Glen Site and MUHC Research Institute
Montreal, Quebec, H4A 3J1, Canada
Beijing Cancer Hospital
Beijing, 100142, China
Hunan Cancer Hospital
Changsha, China
Xiangya Hospital central south university
Changsha, China
Linyi Cancer Hospital
Hangzhou, 310003, China
The First Affiliated Hospital of Zhejiang University
Hangzou, 310022, China
Harbin Medical University Cancer Hospital
Heilongjiang, 150081, China
Jiamusi Cancer Tuberculosis Hospital
Heilongjiang, 154007, China
Fudan University Shanghai Cancer Center
Henan, 450008, China
Hubei Cancer Hospital
Hubei, 430079, China
Jiangsu Province Hospital
Nanjing, China
The First Affiliated Hospital of Xi'an Jiaotong University
Shandong, 276000, China
Shanghai Chest Hospital
Shanghai, China
Henan Cancer Hospital
Shanghai Sheng, 200032, China
Zhejiang Cancer Hospital
Shanxi, 710061, China
West China Hospital, Sichuan University
Sichuan Province, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, 300060, China
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, China
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, 43002, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Zhejiang, 310016, China
Vseobecna Fakultni Nemocnice VFN
Prague, 12800, Czechia
Hopital Jean Minjoz
Besançon, 25030, France
Centre Hospitalier Universitaire de Grenoble
Grenoble, 38043, France
Centre Leon Berard
Lyon, 69008, France
CHU Louis Pradel
Lyon, France
APHM - Hopital Nord
Marseille, 13915, France
University Hospital of Nantes - Thoracic Oncology
Nantes, 44000, France
Institut Curie
Paris, 75248, France
CHU de Poitier Pole regional de Cancerologie
Poitiers, 86000, France
Hopital Pontchaillou
Rennes, 35000, France
Hopitaux Universitaire de Strasbourg
Strasbourg, 67098, France
Hopital Foch
Sureesnes, 92150, France
CHU Toulouse Hopital Larrey
Toulouse, 31059, France
Gustav Roussy Cancer Campus Grand Paris
Villejuif, 94805, France
Charite - Universitaetsmedizin Berlin
Berlin, 10117, Germany
Evangelische Lungenklinik Berlin
Berlin, 13125, Germany
Universitaet zu Koeln - Uniklinik Koeln
Cologne, 50937, Germany
IKF Krankenhaus Nordwest
Frankfurt am Main, 60488, Germany
Universitaetsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Asklepios Fachklinik Muenchen-Gauting
Gauting, 82131, Germany
Thoraxklinik Heidelberg gGmbH
Heidelberg, 69126, Germany
Lungenklinik Hemer
Hemer, 58675, Germany
Klinikverbund Allgäu
Kempten, 87439, Germany
Medizinische Klinik V
Standort Gießen, Germany
Klinikum Traunstein
Traunstein, Germany
Queen Mary Hospital
Hong Kong, 999077, Hong Kong
Prince of Wales Hospital / The Chinese University of Hong Kong
Hong Kong, 99999, Hong Kong
Orszagos Koranyi TBC es Pulmonologiai Intezet
Budapest, 01121, Hungary
Uzsoki Utcai Korhaz
Budapest, 1145, Hungary
Szent Borbala Korhaz
Tatabánya, 02800, Hungary
Tolna Megyei Balassa Janos Korhaz
Tolna, Hungary
Tudogyogyintezet Torokbalint
Törökbálint, H-2045, Hungary
Azienda Ospedaliero- Universitaria Policlinico S. Orsola-Malpighi
Bologna, 40138, Italy
Azienda Ospedaliera Universitaria Policlinico G Rodolico San Marco
Catania, 95030, Italy
ASL 3 Genovese Oncologia Medica Villa Scassi
Genova, 16149, Italy
Fondazione IRCCS Istituto Nazionale Tumori
Milan, 20133, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
IRCCS Istituto Europeo di Oncologia
Milan, 20141, Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Orbassano, 10043, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168, Italy
Instituicao de Fisioterapeutas Ocupacionais
Roma, RM00144, Italy
Hyogo Cancer Center
Akashi, 673-8558, Japan
Niigata Cancer Center Hospital
Chūōku, 951-8566, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Saitama Medical University International Medical Center
Hidaka, 350-1298, Japan
Kansai Medical University Hospital
Hirakata, 573-1191, Japan
Kanazawa University Hospital
Kanazawa, 920-8641, Japan
National Cancer Center Hospital East
Kashiwa, 277-8577, Japan
The Cancer Institute Hospital of JFCR
Kōtoku, 135-8550, Japan
Kyoto University Hospital
Kyoto, 606-8507, Japan
NHO Shikoku Cancer Center
Matsuyama, 791-0280, Japan
Shizuoka Cancer Center
Nagaizumi-chō, 411-8777, Japan
Okayama University Hospital
Okayama, 36927, Japan
Osaka City General Hospital
Osaka, 534-0021, Japan
Osaka International Cancer Institute
Osaka, 541-8567, Japan
Kindai University Hospital
Ōsaka-sayama, 589-8511, Japan
Saitama Cancer Center
Saitama, 362-0806, Japan
Sendai Kousei Hospital
Sendai, 980-0873, Japan
NHO Hokkaido Cancer Center
Shiroishi, 003-0804, Japan
Tokushima University Hospital
Tokushima, 770-8503, Japan
National Cancer Center Hospital
Tokyo, 104-0045, Japan
Fujita Health University Hospital
Toyoake, 470-1192, Japan
San Peregrino Cancer Center
Aguascalientes, 20230, Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, 44280, Mexico
Hospital Medica Sur Tlalpan
Mexico City, 14050, Mexico
Hospital Universitario Jose Eleuterio Gonzalez
Monterrey, 64460, Mexico
Erasmus MC
Amsterdam, 3000 CA, Netherlands
Amphia Ziekenhuis
Breda, 4818 CK, Netherlands
Isala Klinieken
Harderwijk, 3844 DG, Netherlands
St. Jansdal Ziekenhuis
Rotterdam, 3015 CD, Netherlands
II Klinika Chorob Pluc i Gruzlicy
Bialystok, 15-276, Poland
Szpitale Pomorskie Sp.zo.o
Gdynia, 81-519, Poland
Ms Pneumed
Lublin, 20-090, Poland
SP Zespol Gruzlicy i Chorob Pluc
Olsztyn, 10-357, Poland
Med Polonia Sp. z o.o.
Poznan, 60-693, Poland
Szpital Specjalistyczny w Prabutach Sp. z o.o.
Prabuty, 82-550, Poland
Oddział Onkologii Wojewódzki Szpital Specjalistyczny Słupsk
Słupsk, 76-200, Poland
Magodent Sp. z.o.o Szpital Elblaska
Warsaw, 01-748, Poland
Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, 02-781, Poland
FDI Clinical Research
San Juan, 00927, Puerto Rico
SC Oncopremium Team SRL
Baia Mare, 430291, Romania
Institutul Oncologic Profesor Doctor Alexandru Trestioreanu
Bucharest, 022328, Romania
Centrul Medical Sanador
Bucharest, 20125, Romania
Clinical Emergency Hospital
Constanța, 900591, Romania
Onco Clinic Consult SA
Craiova, 200103, Romania
Sf Nectarie Oncology Center
Craiova, 200347, Romania
Oncolab SRL
Craiova, 200385, Romania
SC Oncomed SRL
Timișoara, 300425, Romania
Kursk Regional Clinical Oncology Dispensary
Kursk, 305524, Russia
Federal State Budgetary Institution - N.N. Blokhin National Medical Research Center of Oncology
Moscow, 115478, Russia
University Headache Clinic LLC
Moscow, 121467, Russia
VitaMed LLC
Moscow, 129515, Russia
Institute of Oncology Hadassah Moscow
Moscow, Russia
LLC MSCH "Klinitsist"
Novosibirsk, 630099, Russia
N.N. Petrov Research Institute of Oncology
Saint Petersburg, 197758, Russia
National Cancer Centre Singapore
Singapore, 169610, Singapore
ICON Cancer Centre Farrer Park Hospital
Singapore, 217562, Singapore
OncoCare Cancer Centre - Gleneagles Medical Centre Location
Singapore, 258499, Singapore
Chungbuk National University Hospital
Cheongju-si, 28644, South Korea
Kyungpook National University Chilgok Hospital
Daegu, 41404, South Korea
St. Vincents Hospital The Catholic University of Korea
Gyeonggi-do, 16247, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Yonsei University Health System - Severance Hospital
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea, Seoul St. Marys Hospital
Seoul, 06591, South Korea
Seoul National University Boramae Medical Center
Seoul, 07061, South Korea
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, 08036, Spain
Hospital Universitario Vall d'Hebron
Barcelona, 80350, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Puerte de Hierro de Majadahonda
Madrid, 28222, Spain
Hospital Regional Universitario Málaga
Málaga, 29010, Spain
CHUO
Ourense, 32005, Spain
Hospital Virgen Macarena
Seville, 41007, Spain
Hospital Universitario de Valme
Seville, 41014, Spain
Hospital General Universitario de Valencia
Valencia, 46014, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Hospital Clinico Universitario Lozano Bleza
Zaragoza, 50009, Spain
Inselspital Universitätsspital Bern
Bern, 3010, Switzerland
Kantonsspital St. Gallen
Sankt Gallen, 9007, Switzerland
Stadtspital Waid ; Triemli, Site Triemli - clinic for Medical oncology & hematology
Zurich, 8063, Switzerland
E-Da Hospital
Kaohsiung City, 00824, Taiwan
Chang Gung Memorial Hospital CGMH - Kaohsiung Branch
Niaosong, 00833, Taiwan
Chung Shan Medical University Hospital
Taichung, 00420, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Cheng Kung University Hospital NCKUH
Tainan, 00704, Taiwan
Chi Mei Medical Center CMMC - Liouying Branch
Tainan, 00736, Taiwan
National Taiwan University Hospital NTUH
Taipei, 00100, Taiwan
LinKou Chang Gung Memorial Hospital
Taoyuan District, 333, Taiwan
University College Hospital
London, NW1 2BU, United Kingdom
The Christie Hospital
Manchester, M20 4BX, United Kingdom
The James Cook University Hospital
Middlesbrough, TS4 3BW, United Kingdom
Related Publications (2)
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.
PMID: 41268710DERIVEDAhn 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.
PMID: 39250535DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Contact for Clinical Trial Information
- Organization
- Daiichi Sankyo
Study Officials
- STUDY DIRECTOR
Global Clinical Leader
Daiichi Sankyo
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2020
First Posted
December 7, 2020
Study Start
December 21, 2020
Primary Completion
May 10, 2024
Study Completion (Estimated)
February 15, 2027
Last Updated
March 24, 2026
Results First Posted
July 23, 2025
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
- Access Criteria
- Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
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/