Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer
A Multicenter, Randomized, Open-Label, Phase 3 Trial of Trastuzumab Deruxtecan (Enhertu®) Plus Chemotherapy Plus or Minus Pembrolizumab Versus Chemotherapy Plus Trastuzumab Plus or Minus Pembrolizumab as First-Line Treatment in Participants With Unresectable, Locally Advanced or Metastatic HER2-Positive Gastric Or Gastroesophageal Junction (GEJ) Cancer (Destiny-Gastric05)
3 other identifiers
interventional
726
25 countries
245
Brief Summary
This clinical trial is designed to assess the efficacy and safety of the triplet combination of trastuzumab deruxtecan (ENHERTU, T-DXd, DS-8201a) plus a fluoropyrimidine plus pembrolizumab versus standard of care (SoC) chemotherapy plus trastuzumab plus pembrolizumab as first-line therapy in participants with unresectable, locally advanced or metastatic HER2-positive tumor PD-L1 CPS ≥1 gastric or GEJ cancer in the Main Cohort. An Exploratory Cohort will also be evaluated to assess the efficacy and safety of T-DXd plus a fluoropyrimidine versus SoC chemotherapy plus trastuzumab in participants with unresectable, locally advanced or metastatic HER2-positive tumor PD-L1 CPS \<1 gastric or GEJ cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 gastric-cancer
Started Feb 2025
245 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
December 9, 2024
CompletedFirst Posted
Study publicly available on registry
December 12, 2024
CompletedStudy Start
First participant enrolled
February 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2030
March 16, 2026
March 1, 2026
3.3 years
December 9, 2024
March 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
PFS is defined as the time interval from the date of randomization to the date of radiographic disease progression as assessed by blinded independent central review (BICR) based on RECIST v1.1 or death due to any cause
From date of randomization to the date of radiographic disease progression or death due to any cause, up to 59 months
Secondary Outcomes (1)
Overall Survival (OS)
From date of randomization to the date of death due to any cause, up to 59 months
Study Arms (4)
Main Cohort: Arm M1
EXPERIMENTALParticipants will receive T-DXd plus fluoropyrimidine (5-FU or capecitabine) plus pembrolizumab
Main Cohort: Arm M2
EXPERIMENTALParticipants will receive Trastuzumab plus platinum-based chemotherapy (cisplatin plus 5-FU or oxaliplatin plus capecitabine) plus pembrolizumab
Exploratory Cohort: Arm E1
EXPERIMENTALParticipants will receive T-DXd plus fluoropyrimidine (5-FU or capecitabine)
Exploratory Cohort: Arm E2
EXPERIMENTALParticipants will receive Trastuzumab plus platinum-based chemotherapy (cisplatin plus 5-FU or oxaliplatin plus capecitabine)
Interventions
T-DXd will be administered at a dose of 5.4 mg/kg intravenously (IV) every 3 weeks (Q3W)
Pembrolizumab will be administered at a dose of 200 mg IV Q3W
Trastuzumab will be administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg IV Q3W
For Arms M1 and E1: 5-FU or capecitabine will be administered. For Arms M2 and E2: Cisplatin plus 5-FU or oxaliplatin plus capecitabine will administered.
Eligibility Criteria
You may qualify if:
- Sign and date the Tissue Prescreening ICF, prior to HER2 and PD-L1 CPS central testing. Sign and date the Main Screening ICF, prior to the start of any trial-specific qualification procedures. Sign and date the Optional PGx ICF (included in the Main Screening ICF) prior to any PGx procedure.
- Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is \>18 years old.
- Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma histologically confirmed by pathology report. Prior treatment in the perioperative and/or adjuvant setting is permissible, provided there is \>6 months between the end of perioperative or neoadjuvant treatment and the diagnosis of recurrent disease.
- Note: Prior use of IO (ie, anti-PD-1/PD-L1) therapy in the (neo)adjuvant setting is allowed as long as there is \>6 months between the end of IO therapy and the diagnosis of recurrent disease.
- Centrally determined HER2-positive (IHC 3+ or IHC 2+/ISH-positive) gastric or GEJ cancer as classified by the American Society of Clinical Oncology-College of American Pathologists for GC on a tumor biopsy as detected by prospective central test on new (core, incisional, excisional biopsy) or existing tumor tissue taken at the time of diagnosis of locally advanced or metastatic disease.
- Note: Archival samples taken from a previous diagnostic or surgical biopsy not previously irradiated can be accepted. Details pertaining to tumor tissue submission can be found in the Study Laboratory Manual.
- All participants must provide a tumor sample for tissue-based IHC staining to centrally determine HER2 expression, PD-L1 CPS, and other correlatives. The mandatory FFPE tumor sample can be from either the primary tumor or metastatic biopsy. Specimens with limited tumor content (as centrally determined) and cytology samples are inadequate for defining tumor HER2 and PD-L1 status.
- At least 1 target measurable lesion on CT or MRI, assessed by the investigator based on RECIST v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.
- LVEF ≥50% within 28 days before randomization.
You may not qualify if:
- Prior exposure to other HER2-targeting therapies (including ADCs).
- Lack of physiological integrity of the upper gastrointestinal tract (ie, severe Crohn disease that results in malabsorption) or malabsorption syndrome that would preclude feasibility of oral chemotherapy (ie, capecitabine).
- Known DPD enzyme deficiency. Note: Screening for DPD enzyme deficiency is required only in regions/countries where DPD testing is SoC and with unknown DPD status. For regions/countries where DPD testing is not SoC, local practice should be followed.
- Contraindications to trastuzumab, 5-FU, capecitabine, cisplatin, or oxaliplatin treatment as per local label.
- Medical history of myocardial infarction within 6 months before randomization or symptomatic CHF (New York Heart Association Class II to IV). Participants with troponin levels above ULN at Screening (as defined by the manufacturer) and without any myocardial infarction -related symptoms should have a cardiologic consultation during the Screening Period to rule out myocardial infarction.
- Has a corrected QT interval (QTcF) prolongation to \>470 ms (females) or \>450 ms (males) based on the average of the screening triplicate 12-lead ECG.
- Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening
- Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the trial randomization, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (250)
Yale Cancer Center
New Haven, Connecticut, 06511, United States
Orchard Healthcare Research Inc.
Skokie, Illinois, 60077, United States
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, 66160, United States
Maryland Oncology Hematology, P.A.
Silver Spring, Maryland, 20904, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
University of Michigan Comprehensive Cancer Center Michigan Medicine
Ann Arbor, Michigan, 48109, United States
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, 55404, United States
Memorial Sloan Kettering Cancer Center - MAIN
New York, New York, 10065, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Penn State University Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Prisma Health Cancer Institute, ITOR, CRU
Greenville, South Carolina, 29605, United States
Tennessee Oncology Nashville Midtown
Nashville, Tennessee, 37203, United States
UT Southwestern Medical Center
Dallas, Texas, 75235, United States
Texas Oncology, P.A. - Tyler
Tyler, Texas, 75702, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502-1871, United States
Blue Ridge Cancer Care
Roanoke, Virginia, 24014, United States
Wenatchee Valley Hospital & Clinics
Wenatchee, Washington, 98801, United States
CEMIC Ciudad Autonoma
Buenos Aires, Argentina
Instituto Medico Especializado Alexander Fleming
Buenos Aires, Argentina
Clinica Universitaria Privada Reina Fabiola
Córdoba, Argentina
Centro de Investigaciones Medicas Mar del Plata
Mar del Plata, Argentina
Instituto Medico de la Fundacion Estudios Clinicos
Rosario, Argentina
Flinders Medical Centre
Bedford Park, Australia
Monash Medical Centre Clayton
Clayton, Australia
Townsville University Hospital
Douglas, Australia
Peter MacCallum Cancer Centre
North Melbourne, Australia
GenesisCare North Shore (Oncology)
St Leonards, Australia
St John of God Subiaco Hospital
Subiaco, Australia
Wollongong Hospital
Wollongong, Australia
LKH - Universitaetsklinikum Graz
Graz, Austria
Medizinische Universität Innsbruck
Innsbruck, Austria
Medizinische Universität Wien
Vienna, Austria
St. Josef Krankenhaus Wien
Vienna, Austria
Landesklinikum Wiener Neustadt
Wiener Neustadt, Austria
Institut Jules Bordet
Anderlecht, Belgium
AZ Sint-Lucas
Bruges, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
UZ Leuven
Leuven, Belgium
Centre Hospitalier Universitaire de Liege
Liège, Belgium
CHU UCL Namur
Namur, Belgium
Centro de Oncologia - Unidade Brasilia - Hospital Sirio Libanes
Brasília, Brazil
ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira Sao Paulo
Brazil, Brazil
CEPON - Centro de Pesquisas Oncológicas de Santa Catarina
Florianópolis, Brazil
Fundação Doutor Amaral Carvalho
Jaú, Brazil
Liga Norte-Rio-Grandense Contra o Câncer
Natal, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Brazil
Hospital São Lucas da PUCRS
Porto Alegre, Brazil
IMIP - Instituto de Medicina Integral Professor Fernando Figueira
Recife, Brazil
Hospital das Clínicas FMRP-USP
Ribeirão Preto, Brazil
INCA - Instituto Nacional de Câncer
Rio de Janeiro, Brazil
Obras Sociais Irmã Dulce - Hospital Santo Antônio
Salvador, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
Sao Jose Rio Preto, Brazil
Cité de la Santé de Laval
Laval, H7M 3L9, Canada
Trillium Health Partners Credit Valley Hospital
Mississauga, L5M 2N1, Canada
St. Mary's Hospital
Montreal, H3T 1M5, Canada
CHUS - Hôtel-Dieu
Sherbrooke, Canada
Mount Sinai Hospital
Toronto, M5G 1X5, Canada
Mount Sinai Hospital
Toronto, M5G 1X5, Canada
Sunnybrook Health Sciences Centre
Toronto, Canada
University Health Network - Princess Margaret Cancer Centre
Toronto, Canada
Biocenter
Concepción, Chile
URUMED Spa
Rancagua, Chile
Centro de Investigacion del Maule
Region Del Maule, Chile
Centro de Estudios Clinicos SAGA
Santiago, Chile
FALP - Fundación Arturo López Pérez
Santiago, Chile
Hospital Clinico Universidad de Chile
Santiago, Chile
Beijing Cancer Hospital
Beijing, 100142, China
Peking University Third Hospital
Beijing, 100191, China
The First People's Hospital of Changzhou
Changzhou, China
Fujian Cancer Hospital
Fuzhou, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, China
The First Affiliated Hospital of Zhejiang University school of medicine
Hangzhou, China
Harbin Medical University Cancer Hospital
Harbin, China
Anhui Provincial Cancer Hospital
Hefei, China
Shandong Cancer Hospital
Jinan, China
Gansu Provincial Cancer Hospital
Lanzhou, China
Lanzhou University Second Hospital
Lanzhou, China
Linyi Cancer Hospital
Linyi, China
Meizhou People's Hospital
Meizhou, China
Liaoning Cancer Hospital & Institute
Shenyang, China
The Second Affiliated Hospital of Soochow University
Suzhou, China
Shanxi Provincial Cancer Hospital
Taiyuan, China
Shanxi Provincial People's Hospital
Taiyuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
The Affiliated Cancer Hospital of Xinjiang Medical university
Ürümqi, China
Hubei Cancer Hospital
Wuhan, 430079, China
Wuxi 4th People's Hospital
Wuxi, China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, China
The First Affiliated Hospital of Xiamen University
Xiamen, China
Fudan University Shanghai Cancer Center
Xuhui District, China
Xuzhou Central Hospital
Xuzhou, China
General Hospital of Ningxia Medical University
Yinchuan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Masarykuv onkologicky ustav
Brno, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia
Fakultni nemocnice Olomouc
Olomouc, Czechia
Fakultni nemocnice v Motole
Prague, Czechia
Institut Sainte Catherine
Avignon, France
CHU de Brest - Hopital de la Cavale Blanche
Brest, France
Centre Georges François Leclerc
Dijon, France
CHU Grenoble - Hopital Michallon
Grenoble, France
Centre Oscar Lambret
Lille, France
Hopital Prive Jean Mermoz
Lyon, France
CHU Montpellier, Saint Eloi
Montpellier, France
Chru De Nantes Hotel-Dieu
Nantes, France
Hôpital Européen Georges Pompidou
Paris, France
Hôpital Saint-Antoine
Paris, France
Institut Mutualiste Montsouris
Paris, France
CHU Bordeaux - Hôpital Haut-Lévêque
Pessac, France
CHU Poitiers - Hôpital la Milétrie
Poitiers, France
Institut de Cancérologie de Strasbourg Europe - ICANS
Strasbourg, France
Hôpital Foch
Suresnes, France
Hopital Rangueil
Toulouse, France
Charité Universitätsmedizin Berlin - Campus Virchow-Klinikum
Berlin, Germany
Vivantes Klinikum im Friedrichshain
Berlin, Germany
Klinikum Chemnitz gGmbH
Chemnitz, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, Germany
Universitaetsklinikum Frankfurt Goethe-Universitaet
Frankfurt am Main, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, Germany
Universitaetsklinikum Heidelberg
Heidelberg, Germany
Universitaetsklinikum Leipzig AoeR
Leipzig, Germany
Klinikum rechts der Isar der TU Muenchen
München, Germany
Presidio Ospedaliero Garibaldi Nesima
Catania, Italy
Azienda Ospedaliera Universitaria Careggi
Florenze, Italy
IRCCS Ospedale Policlinico San Martino
Genova, Italy
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
Milan, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
Ospedale San Raffaele
Milan, Italy
A.O.U. Policlinico di Modena
Modena, Italy
Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"
Naples, Italy
IOV - Istituto Oncologico Veneto IRCCS
Padua, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Azienda Unità Sanitaria Locale- Ravenna
Ravenna, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy
Istituto Clinico Humanitas
Rozzano, Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Italy
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Torino, Italy
Azienda Ospedaliera Card. G. Panico
Tricase, Italy
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Bunkyō City, Japan
National Cancer Center Hospital
Chūōku, Japan
Gifu University Hospital
Gifu, Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Japan
National Cancer Center Hospital East
Kashiwa-shi, Japan
JCHO Kyushu Hospital
Kitakyushu, 806-0034, Japan
Kochi Health Sciences Center
Kochi, Japan
Cancer Institute Hospital of JFCR
Kōtoku, 135-8550, Japan
NHO Shikoku Cancer Center
Matsuyama, 791-0280, Japan
Aichi Cancer Center Hospital
Nagoya, Japan
Miyagi Cancer Center
Natori-shi, Japan
Niigata Cancer Center Hospital
Niigata, 951-8566, Japan
Osaka International Cancer Institute
Osaka, 541-8567, Japan
Kindai University Hospital
Osakasayama-shi, 589-8511, Japan
Hokkaido University Hospital
Sapporo, 060-8648, Japan
Osaka University Hospital
Suita-shi, 565-0871, Japan
Kanagawa Cancer Center
Yokohama, 241-8515, Japan
Antoni van Leeuwenhoek
Amsterdam, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
Radboudumc
Nijmegen, Netherlands
Erasmus Medisch Centrum
Rotterdam, Netherlands
ETZ Elisabeth
Tilburg, Netherlands
UMC Utrecht
Utrecht, Netherlands
Haukeland University Hospital
Bergen, Norway
Akershus universitetssykehus HF
Lørenskog, Norway
Oslo Universitetssykehus HF, Ullevål
Oslo, Norway
St. Olavs Hospital Hf, Universitetssykehuset i Trondheim
Trondheim, Norway
Beskidzkie Centrum Onkologii im.Jana Pawla II
Bielsko-Biala, Poland
Szpital Wojewodzki im. Mikolaja Kopernika
Koszalin, Poland
Wielkopolskie Centrum Onkologii
Poznan, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej Curie Panstwowy Instytut Badawczy W Warszawie
Warsaw, Poland
Warszawski Uniwersytet Medyczny
Warsaw, Poland
Hospital de Braga
Braga, Portugal
Hospital da Senhora da Oliveira Guimarães, E.P.E.
Guimarães, Portugal
Fundação Champalimaud
Lisbon, Portugal
Hospital da Luz
Lisbon, Portugal
Unidade Local de Saúde de Santa Maria, E.P.E. - Hospital de Santa Maria
Lisbon, Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Porto, Portugal
Institutul Clinic Fundeni
Bucharest, Romania
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca
Cluj-Napoca, Romania
S.C Medisprof S.R.L
Cluj-Napoca, Romania
Centrul de Oncologie Sfantul Nectarie Craiova
Craiova, Romania
Institutul Regional de Oncologie Iasi
Iași, Romania
S.C Ovidius Clinical Hospital S.R.L
Ovidiu, Romania
S.C. Sigmedical Services SRL
Suceava, Romania
Chungbuk National University Hospital
Cheongju-si, South Korea
Kyungpook National University Chilgok Hospital
Daegu, South Korea
National Cancer Center
Goyang-si, South Korea
Chonnam National University Hwasun Hospital
Hwasun-gun, 58128, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Jeonbuk national university hospital
Jeonju, 54907, South Korea
Seoul National University Bundang Hospital
Seongnam, 13620, South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si, South Korea
Korea University Anam Hospital
Seoul, 2841, South Korea
Seoul National University Hospital
Seoul, 3080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 3722, South Korea
Asan Medical Center
Seoul, 5505, South Korea
Samsung Medical Center
Seoul, 6351, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
ICO Badalona - Hospital Universitari Germans Trias i Pujol
Badalona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Universitario Reina Sofia
Córdoba, Spain
Hospital General Universitario de Elche
Elche, Spain
ICO l'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
MD Anderson Cancer Centre
Madrid, Spain
Hospital Regional Universitario de Malaga
Málaga, Spain
Hospital General Universitario Morales Meseguer
Murcia, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain
Hospital Universitario de Navarra
Pamplona, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Taipei Veterans General Hospital
Taipei, 112201, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital,Linkou
Taoyuan, 333, Taiwan
Siriraj Hospital
Bangkoknoi, Thailand
Vajira Hospital
Dusit, Thailand
Songklanagarind Hospital
Hat Yai, Thailand
Chulabhorn Hospital
Laksi, Thailand
King Chulalongkorn Memorial Hospital
Pathum Wan, Thailand
Medical Park Seyhan Hospital
Adana, Turkey (Türkiye)
Ankara City Hospital
Ankara, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
Ankara, Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, Turkey (Türkiye)
Dicle University, Medical faculty
Diyarbakır, Turkey (Türkiye)
Ataturk University Medical Faculty
Erzurum, Turkey (Türkiye)
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Istanbul, Turkey (Türkiye)
Medipol University Medical Faculty
Istanbul, Turkey (Türkiye)
İ.E.Ü. Medicalpoint İzmir Hastanesi
Izmir, Turkey (Türkiye)
Medical Park Samsun Hastanesi
Samsun, Turkey (Türkiye)
Queen Elizabeth Hospital
Birmingham, United Kingdom
Velindre Cancer Centre
Cardiff, United Kingdom
Ninewells Hospital
Dundee, United Kingdom
Castle Hill Hospital
Hull, United Kingdom
St James's University Hospital
Leeds, United Kingdom
Sarah Cannon Research Institute UK
London, United Kingdom
University College London Hospitals
London, United Kingdom
Altnagelvin Area Hospital
Londonderry, United Kingdom
The Christie Hospital
Manchester, United Kingdom
Royal Marsden Hospital
Sutton, United Kingdom
Hanoi Oncology hospital
Hanoi, Vietnam
National Cancer Hospital
Hanoi, Vietnam
Cho Ray Hospital
Ho Chi Minh City, Vietnam
HCMC Oncology Hospital
Ho Chi Minh City, Vietnam
HCMC University Medical Center
HoChiMinh, Vietnam
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- This is an open-label study.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2024
First Posted
December 12, 2024
Study Start
February 27, 2025
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
February 1, 2030
Last Updated
March 16, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Completed studies that has reached a global end or completion with all data set collected and analyzed, and 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 on completed 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) on completed studies 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/