search
Back to results

Trastuzumab Deruxtecan for Subjects With HER2-Positive Gastric Cancer or Gastro-Esophageal Junction Adenocarcinoma After Progression on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04)

Primary Purpose

Gastric Cancer, Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Trastuzumab deruxtecan
Ramucirumab
Paclitaxel
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer, Adenocarcinoma focused on measuring Gastric Cancer, Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Trastuzumab deruxtecan, T-DXd, DS-8201a, Ramucirumab, Paclitaxel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults (according to local regulation) and able to provide informed consent for study participation.
  • Pathologically documented gastric and GEJ adenocarcinoma that has been previously treated in the metastatic setting (unresectable, locally advanced, or metastatic disease).
  • Progression on or after first-line therapy with a trastuzumab or approved trastuzumab biosimilar-containing regimen. Note: Prior neoadjuvant or adjuvant therapy with a trastuzumab-containing regimen can be counted as a line of therapy if the subject progressed on or within 6 months of completing neoadjuvant or adjuvant therapy. Prior neoadjuvant or adjuvant therapy that does not include trastuzumab will not be counted as a line of therapy regardless of the progression status of the subject.
  • Centrally confirmed HER2-positive (IHC 3+ or IHC 2+ and evidence of HER2 amplification by ISH) as classified by ASCO-CAP on a tumor biopsy obtained after progression on or after a first-line trastuzumab or approved trastuzumab biosimilar-containing regimen.
  • Eastern Cooperative Oncology Group performance status of 0 or 1 at Screening.
  • Adequate bone marrow, renal, and hepatic function within 14 days of randomization.

Exclusion Criteria:

  • Use of anticancer therapy after trastuzumab-containing treatment
  • Medical history of myocardial infarction (MI) within 6 months before randomization/enrollment, symptomatic congestive heart failure (New York Heart Association Class II to IV).
  • Has a QT interval corrected by Fridericia's formula (QTcF) prolongation to >470 msec (female subjects) or >450 msec (male subjects) based on average of the Screening triplicate12-lead ECG.
  • 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.
  • Any autoimmune, connective tissue or inflammatory disorders (eg, rheumatoid arthritis, Sjögren syndrome, sarcoidosis, etc.) where there is documented (or a suspicion of) pulmonary involvement at the time of Screening.
  • Prior complete pneumonectomy.
  • 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.
  • Has multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated.
  • History of severe hypersensitivity reactions to either the T-DXd or inactive ingredients in T-DXd.
  • History of severe hypersensitivity reactions to other monoclonal antibodies, including ramucirumab or to any of its excipients.
  • Known allergy or hypersensitivity to paclitaxel or any components used in the paclitaxel preparation or other contraindication for taxane therapy.
  • Current uncontrolled infection requiring antibiotics, antivirals, or antifungals or an unexplained fever >38.0°C during Screening visits or on the first scheduled day of dosing (at the discretion of the Investigator, participants with tumor fever may be enrolled), which in the Investigator's opinion might compromise the participant's participation in the study or affect the study outcome
  • Clinically significant gastrointestinal disorder (eg, including hepatic disorders, bleeding, inflammation, occlusion, ileus, diarrhea Grade >1, jaundice, intestinal paralysis, malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, or partial bowel obstruction) in the opinion of Investigator

Sites / Locations

  • Instituto Medico Especializado Alexander FlemingRecruiting
  • IONC Instituto Oncologico de Cordoba - Fundacion Richardet Longo
  • ExelsusRecruiting
  • Fundacion CenitRecruiting
  • UCL St. LucRecruiting
  • Antwerp University HospitalRecruiting
  • Pôle Hospitalier JolimontRecruiting
  • UZ LeuvenRecruiting
  • PERSONAL - Oncologia de Precisao e PersonalizadaRecruiting
  • Hospital Sirio LibanesRecruiting
  • ONCOSITE - Centro de Pesquisa Clinica em Oncologia LTDARecruiting
  • Hospital Ernesto Dornelles
  • SIM Centro de Investigacion Clinica
  • Fundacion Arturo Lopez PerezRecruiting
  • Clinica San Carlos de ApoquindoRecruiting
  • Anhui Provincial HospitalRecruiting
  • Fujian Medical University - Fujian Provincial Cancer HospitalRecruiting
  • Xiamen University - The First Affiliated HospitalRecruiting
  • The Sixth Affiliated Hospital of Sun Yat-Sen UniversityRecruiting
  • 1Affiliated H of Sun Yat Sen URecruiting
  • Hebei Medical Univ 4th HospRecruiting
  • Harbin Medical University Cancer HospitalRecruiting
  • The First Affiliated Hospital of Zhengzhou UniversityRecruiting
  • Zhongnan univ Xiangya hospRecruiting
  • Jiangsu Province HospRecruiting
  • Liaoning Cancer HospitalRecruiting
  • 1st Hosp of China Medical UnivRecruiting
  • Shandong Cancer Hospital & InstituteRecruiting
  • Zhongshan Hosp Fudan UnivRecruiting
  • Shanghai First People's HospRecruiting
  • Xinjiang Medical University - Cancer HospitalRecruiting
  • Zhejiang Medical University - Zhejiang Cancer HospitalRecruiting
  • Beijing Cancer HospitalRecruiting
  • Peking Univ 3rd HospRecruiting
  • The 1st Hospital of Jilin UnivRecruiting
  • Sir Run Run Shaw HospitalRecruiting
  • Linyi Cancer HospitalRecruiting
  • 1 Affiliated H of Nanchang URecruiting
  • Fudan University - Shanghai Cancer CenterRecruiting
  • CHU BesançonRecruiting
  • CHRURecruiting
  • Centre Oscar LambretRecruiting
  • Centre Leon BerardRecruiting
  • Hopital de la TimoneRecruiting
  • Institut de Recherche en Cancerologie de Montpellier IRCMRecruiting
  • Hopital Saint AntoineRecruiting
  • L Institut Mutualiste MontsourisRecruiting
  • Hopital Europeen G. PompidouRecruiting
  • Centre Hospitalier Universitaire CHU de Rennes - Hopital de Pontchaillou
  • Pharmacie ICLNRecruiting
  • Gustave Roussy, étage -1.Recruiting
  • Charité-Unimedizin Berlin
  • Uniklinikum Carl-Gustav-Carus
  • Evang. Klin. Essen-Mitte gGmbH
  • Ins. für klinische onk. Forschung
  • Häm-Onk. Praxis Eppendorf
  • Asklepios Tumorzentrum Altona
  • Uni zu Koln-Unikl. Koln
  • Universitares Krebszentrum
  • Pamela Youde Nethersole Eastern HospitalRecruiting
  • Princess Margaret HospitalRecruiting
  • Queen Mary HospitalRecruiting
  • The Chinese University of Hong Kong (CUHK) - Prince of Wales Hospital (PWH) - Vascular and Interventional Radiology Foundation (VIRF) Clinical Science CentreRecruiting
  • Magyar Honvedseg Egeszs. KRecruiting
  • Debreceni Egyetem Klinikai
  • Tolna M. Balassa Janos KorhazRecruiting
  • Cork University Hospital
  • Tallaght University HospitalRecruiting
  • Beaumont HospitalRecruiting
  • St James's HospitalRecruiting
  • Soroka Univ Medical CTRRecruiting
  • Davidoff CenterRecruiting
  • The Chaim Sheba Medical CenterRecruiting
  • AOU PisanaRecruiting
  • IRCC-FPO Candiolo
  • AOU Mater DominiRecruiting
  • San Raffaele Hospital
  • Istituto Nazionale dei TumoriRecruiting
  • Istituto Europeo di Oncologia S.r.L Divisione di Oncologia Medica Gastrointestinale e Tumori NeuroendocriniRecruiting
  • Ospedale NiguardaRecruiting
  • Istituto Oncologico VenetoRecruiting
  • Azienda Ospedaliero-Universitaria PisanaRecruiting
  • Aou VanvitelliRecruiting
  • Aichi Cancer Center HospitalRecruiting
  • National Cancer Center HospitalRecruiting
  • Osaka International Cancer InstituteRecruiting
  • Gifu University HospitalRecruiting
  • National Cancer Center Hospital EastRecruiting
  • Kobe City Medical Center General HospitalRecruiting
  • Kochi Health Sciences CenterRecruiting
  • The Cancer Institute Hospital of JFCRRecruiting
  • National Hospital Organization Shikoku Cancer CenterRecruiting
  • Niigata Cancer Center HospitalRecruiting
  • Osaka University HospitalRecruiting
  • Kindai University HospitalRecruiting
  • Kyungpook Nat Uni Chilgok HosRecruiting
  • Chonnam National University Hwasun HospitalRecruiting
  • Seoul Nati Univ Bundang HospRecruiting
  • Korea Univ Anam HospRecruiting
  • Seoul National University HospitalRecruiting
  • Severance HospitalRecruiting
  • Asan Medical CenterRecruiting
  • Samsung Medical CenterRecruiting
  • Seoul St. Marys HospitalRecruiting
  • Chonbuk National University Hospital - Jeonbuk Regional Cancer CenterRecruiting
  • Sklodowska-Curie Inst OncologyRecruiting
  • Uniwersytecki Szpital Kliniczny im.Mikulicza-RadeckiegoRecruiting
  • Hospital Sra da OliveiraRecruiting
  • Instituto Portugues De Oncologia Do Porto Francisco Gentil, E.P.E.Recruiting
  • C Hosp Tras Montes Alto DouroRecruiting
  • S.C. Oncopremium-Team SRL
  • Institutul Oncologic Prof. Dr. Alexandru Trestiorean Bucuresti IOB
  • S.C. Medisprof SRL
  • Centrul de Oncologie Sf. Nectarie
  • SBIH Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine
  • City Clinical Oncology Dispensary
  • Private Medical Institution "Euromedservice"
  • Republican Clinical Oncology Dispensary
  • National Univ Cancer Inst SGPRecruiting
  • National Cancer Centre SingaporeRecruiting
  • Hospital Vall d'HebronRecruiting
  • Hospital Clinic de BarcelonaRecruiting
  • Hospital Germans Trias i PujolRecruiting
  • H. Gregorio MaranonRecruiting
  • Hosp Univ Ramón y CajalRecruiting
  • Hospital Universitario La PazRecruiting
  • Hospital de NavarraRecruiting
  • Hospital Clinico Universitario de Santiago de CompostelaRecruiting
  • H. Clinico U. de ValenciaRecruiting
  • KMUHRecruiting
  • CGMF-Kaohsiung BranchRecruiting
  • China Medical Univ HospRecruiting
  • National Cheng Kung Univ HospRecruiting
  • National Taiwan University Hospital NTUHRecruiting
  • MacKay Memorial Hospital
  • Taipei Veterans General HospRecruiting
  • CGMF-Linkou BranchRecruiting
  • SBU Adana Sehir HastanesiRecruiting
  • Trakya Universitesi BalkanRecruiting
  • Suleyman Yalcin Seh. Hast.Recruiting
  • Inonu Uni. Turgut Ozal TipRecruiting
  • National Cancer Institute
  • MedicalCenter ASKLEPION LLC
  • LLC "Oncolife"
  • Queens University Belfast - Centre for Cancer Research and Cell Biology CCRCB
  • University Hospitals Birmingham UHB NHS Foundation Trust - Queen Elizabeth Hospital Birmingham QEHBRecruiting
  • Addenbrooke's HospitalRecruiting
  • Velindre NHS Trust - Velindre Cancer Centre VCCRecruiting
  • Ninewells HospitalRecruiting
  • Beatson West of Scotland Cancer CentreRecruiting
  • The Clatterbridge Cancer Centre NHS Foundation TrustRecruiting
  • UCLH TrustRecruiting
  • Royal Marsden NHSRecruiting
  • Christie HospitalRecruiting
  • University of Oxford, The Churchill Hospital
  • Royal Marsden SuttonRecruiting
  • Leeds Teaching Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Trastuzumab deruxtecan

Ramucirumab + paclitaxel

Arm Description

Participants who will be randomized to receive a 6.4 mg/kg intravenous (IV) dose of trastuzumab deruxtecan once every 3 weeks on Day 1 of each 21-day cycle.

Participants who will be randomized to receive a 8 mg/kg IV dose of ramucirumab on Days 1 and 15 in combination with 80 mg/m^2 IV dose of paclitaxel on Days 1, 8, and 15 of a 28-day cycle.

Outcomes

Primary Outcome Measures

Overall Survival in Participants Who Were Administered Trastuzumab Deruxtecan Compared With Ramucirumab in Combination With Paclitaxel
Overall survival (OS) is defined as the time from date of randomization until death from any cause.

Secondary Outcome Measures

Progression-free Survival in Participants Who Were Administered Trastuzumab Deruxtecan Compared With Ramucirumab in Combination With Paclitaxel
Progression-free survival (PFS) is defined as the time from date of randomization until first objective radiographic tumor progression or death from any cause, based on Investigator assessment.
Objective Response Rate in Participants Who Were Administered Trastuzumab Deruxtecan Compared With Ramucirumab in Combination With Paclitaxel
Objective response rate (ORR) is defined as the proportion of participants who achieve a best response of complete response (CR) or partial response (PR) using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by Investigator.
Duration of Response in Participants Who Were Administered Trastuzumab Deruxtecan Compared With Ramucirumab in Combination With Paclitaxel
Duration of response (DoR) is defined time from the initial response (CR or PR) until documented tumor progression or death from any cause and based on Investigator assessment.
Disease Control Rate in Participants Who Were Administered Trastuzumab Deruxtecan Compared With Ramucirumab in Combination With Paclitaxel
Disease control rate (DCR) is defined as the proportion of participants who achieved CR, PR, or stable disease (SD) for a minimum of 6 weeks during study treatment, based on Investigator assessment.
Incidence of Treatment-emergent Adverse Events (TEAE), Serious Adverse Events (SAE), Adverse Events of Special Interest (AESI), and Physical Examination Findings
Adverse events will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0.
Serum Concentrations for Trastuzumab Deruxtecan, total anti-HER2 antibody, and Active Metabolite MAAA-1181a
Percentage of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline)
The immunogenicity of trastuzumab deruxtecan will be assessed.
Percentage of Participants Who Have Treatment-emergent ADAs
The immunogenicity of trastuzumab deruxtecan will be assessed.

Full Information

First Posted
January 8, 2021
Last Updated
September 5, 2023
Sponsor
Daiichi Sankyo, Inc.
Collaborators
AstraZeneca
search

1. Study Identification

Unique Protocol Identification Number
NCT04704934
Brief Title
Trastuzumab Deruxtecan for Subjects With HER2-Positive Gastric Cancer or Gastro-Esophageal Junction Adenocarcinoma After Progression on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04)
Official Title
A Phase 3, Multicenter, 2-Arm Randomized, Open-Label Study of Trastuzumab Deruxtecan in Subjects With HER2-Positive Metastatic and/or Unresectable Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma Subjects Who Have Progressed on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 21, 2021 (Actual)
Primary Completion Date
April 15, 2024 (Anticipated)
Study Completion Date
November 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.
Collaborators
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with ramucirumab and paclitaxel (Ram + PTX) in participants with HER2-positive gastric or gastro-esophageal junction (GEJ) adenocarcinoma who have progressed on or after a trastuzumab-containing regimen and have not received any additional systemic therapy.
Detailed Description
This study will assess the efficacy and safety of T-DXd compared with Ram + PTX in participants with HER2-positive (defined as immunohistochemistry [IHC] 3+ or IHC 2+/in situ hybridization [ISH]+) gastric or GEJ adenocarcinoma (based on [American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines who have progressed on or after a trastuzumab-containing regimen and have not received any additional systemic therapy. Participants will be randomized 1:1 to either T-DXd or Ram + PTX treatment. The primary objective will assess overall survival. Secondary objectives will further assess progression-free survival, objective response rate, duration of response, disease control rate, safety, pharmacokinetics, and immunogenicity of T-DXd.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
Keywords
Gastric Cancer, Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Trastuzumab deruxtecan, T-DXd, DS-8201a, Ramucirumab, Paclitaxel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
490 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trastuzumab deruxtecan
Arm Type
Experimental
Arm Description
Participants who will be randomized to receive a 6.4 mg/kg intravenous (IV) dose of trastuzumab deruxtecan once every 3 weeks on Day 1 of each 21-day cycle.
Arm Title
Ramucirumab + paclitaxel
Arm Type
Active Comparator
Arm Description
Participants who will be randomized to receive a 8 mg/kg IV dose of ramucirumab on Days 1 and 15 in combination with 80 mg/m^2 IV dose of paclitaxel on Days 1, 8, and 15 of a 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Trastuzumab deruxtecan
Other Intervention Name(s)
T-DXd, DS-8201a, ENHERTU®
Intervention Description
6.4 mg/kg IV infusion every 3 weeks on Day 1 of each 21-day cycle
Intervention Type
Drug
Intervention Name(s)
Ramucirumab
Other Intervention Name(s)
CYRAMZA®
Intervention Description
8 mg/kg IV infusion on Days 1 and 15 of a 28-day cycle
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
80 mg/m^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle
Primary Outcome Measure Information:
Title
Overall Survival in Participants Who Were Administered Trastuzumab Deruxtecan Compared With Ramucirumab in Combination With Paclitaxel
Description
Overall survival (OS) is defined as the time from date of randomization until death from any cause.
Time Frame
Time from date of randomization until death (due to any cause), up to approximately 36 months
Secondary Outcome Measure Information:
Title
Progression-free Survival in Participants Who Were Administered Trastuzumab Deruxtecan Compared With Ramucirumab in Combination With Paclitaxel
Description
Progression-free survival (PFS) is defined as the time from date of randomization until first objective radiographic tumor progression or death from any cause, based on Investigator assessment.
Time Frame
Time from date of randomization until first objective radiographic disease progression or death (due to any cause) whichever occurs first, up to approximately 36 months
Title
Objective Response Rate in Participants Who Were Administered Trastuzumab Deruxtecan Compared With Ramucirumab in Combination With Paclitaxel
Description
Objective response rate (ORR) is defined as the proportion of participants who achieve a best response of complete response (CR) or partial response (PR) using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by Investigator.
Time Frame
From start of treatment to date of documented disease progression, up to approximately 36 months
Title
Duration of Response in Participants Who Were Administered Trastuzumab Deruxtecan Compared With Ramucirumab in Combination With Paclitaxel
Description
Duration of response (DoR) is defined time from the initial response (CR or PR) until documented tumor progression or death from any cause and based on Investigator assessment.
Time Frame
Time from initial response (CR or PR) to date of documented disease progression or death (due to any cause) whichever occurs first, up to approximately 36 months
Title
Disease Control Rate in Participants Who Were Administered Trastuzumab Deruxtecan Compared With Ramucirumab in Combination With Paclitaxel
Description
Disease control rate (DCR) is defined as the proportion of participants who achieved CR, PR, or stable disease (SD) for a minimum of 6 weeks during study treatment, based on Investigator assessment.
Time Frame
From start of treatment to date of documented disease progression, up to approximately 36 months
Title
Incidence of Treatment-emergent Adverse Events (TEAE), Serious Adverse Events (SAE), Adverse Events of Special Interest (AESI), and Physical Examination Findings
Description
Adverse events will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0.
Time Frame
From time subjects signs informed consent form up to 40 days after last study dose
Title
Serum Concentrations for Trastuzumab Deruxtecan, total anti-HER2 antibody, and Active Metabolite MAAA-1181a
Time Frame
Cycles 1-4 and subsequent cycles on Day 1 pre- and post-infusion (each cycle is 28 days)
Title
Percentage of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline)
Description
The immunogenicity of trastuzumab deruxtecan will be assessed.
Time Frame
Cycles 1, 2, and 4 on Day 1 pre-infusion, then every 4 cycles on Day 1 pre-infusion, 40 day follow up until death, withdrawal of consent, or lost to follow up whichever occurs first (each cycle is 28 days)
Title
Percentage of Participants Who Have Treatment-emergent ADAs
Description
The immunogenicity of trastuzumab deruxtecan will be assessed.
Time Frame
Cycles 1, 2, and 4 on Day 1 pre-infusion, then every 4 cycles on Day 1 pre-infusion, 40 day follow up until death, withdrawal of consent, or lost to follow up whichever occurs first (each cycle is 28 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults (according to local regulation) and able to provide informed consent for study participation. Pathologically documented gastric and GEJ adenocarcinoma that has been previously treated in the metastatic setting (unresectable, locally advanced, or metastatic disease). Progression on or after first-line therapy with a trastuzumab or approved trastuzumab biosimilar-containing regimen. Note: Prior neoadjuvant or adjuvant therapy with a trastuzumab-containing regimen can be counted as a line of therapy if the subject progressed on or within 6 months of completing neoadjuvant or adjuvant therapy. Prior neoadjuvant or adjuvant therapy that does not include trastuzumab will not be counted as a line of therapy regardless of the progression status of the subject. Locally or centrally confirmed HER2-positive (IHC 3+ or IHC 2+ and evidence of HER2 amplification by ISH) as classified by ASCO-CAP on a tumor biopsy obtained after progression on or after a first-line trastuzumab or approved trastuzumab biosimilar-containing regimen. Eastern Cooperative Oncology Group performance status of 0 or 1 at Screening. Adequate bone marrow, renal, hepatic function, and blood clotting function within 14 days of randomization. Exclusion Criteria: Use of anticancer therapy after trastuzumab-containing treatment Medical history of myocardial infarction (MI) within 6 months before randomization/enrollment, symptomatic congestive heart failure (New York Heart Association Class II to IV). Has a QT interval corrected by Fridericia's formula (QTcF) prolongation to >470 msec (female subjects) or >450 msec (male subjects) based on average of the Screening triplicate12-lead ECG. 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. Any autoimmune, connective tissue or inflammatory disorders (eg, rheumatoid arthritis, Sjögren syndrome, sarcoidosis, etc.) where there is documented (or a suspicion of) pulmonary involvement at the time of Screening. Prior complete pneumonectomy. 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. Has multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated. History of severe hypersensitivity reactions to either the T-DXd or inactive ingredients in T-DXd. History of severe hypersensitivity reactions to other monoclonal antibodies, including ramucirumab or to any of its excipients. Known allergy or hypersensitivity to paclitaxel or any components used in the paclitaxel preparation or other contraindication for taxane therapy. Current uncontrolled infection requiring antibiotics, antivirals, or antifungals or an unexplained fever >38.0°C during Screening visits or on the first scheduled day of dosing (at the discretion of the Investigator, participants with tumor fever may be enrolled), which in the Investigator's opinion might compromise the participant's participation in the study or affect the study outcome Clinically significant gastrointestinal disorder (eg, including hepatic disorders, bleeding, inflammation, occlusion, ileus, diarrhea Grade >1, jaundice, intestinal paralysis, malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, or partial bowel obstruction) in the opinion of Investigator Has history of receiving live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first exposure to study intervention
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
(EU & UK sites) Daiichi Sankyo Contact for Clinical Trial Information
Phone
908-992-6400
Email
CTRinfo@dsi.com
First Name & Middle Initial & Last Name or Official Title & Degree
(Asia sites) Daiichi Sankyo Contact for Clinical Trial Information
Phone
+81-3-6225-1111(M-F 9-5 JST)
Email
dsclinicaltrial@daiichisankyo.co.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Instituto Medico Especializado Alexander Fleming
City
Colegiales
State/Province
Caba
ZIP/Postal Code
C1426
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
IONC Instituto Oncologico de Cordoba - Fundacion Richardet Longo
City
Nueva Cordoba
State/Province
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Exelsus
City
San Miguel De Tucumán
State/Province
Tucumán
ZIP/Postal Code
4000
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Fundacion Cenit
City
Buenos Aires
ZIP/Postal Code
C1125 ABD
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
UCL St. Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Antwerp University Hospital
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Pôle Hospitalier Jolimont
City
Haine-Saint-Paul
ZIP/Postal Code
7100
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
PERSONAL - Oncologia de Precisao e Personalizada
City
Belo Horizonte
ZIP/Postal Code
30130-090
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hospital Sirio Libanes
City
Brasilia
ZIP/Postal Code
70200-730
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
ONCOSITE - Centro de Pesquisa Clinica em Oncologia LTDA
City
Ijui
ZIP/Postal Code
98700-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Hospital Ernesto Dornelles
City
Porto Alegre
ZIP/Postal Code
90160-092
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
SIM Centro de Investigacion Clinica
City
Temuco
State/Province
Cautin
ZIP/Postal Code
4810469
Country
Chile
Individual Site Status
Terminated
Facility Name
Fundacion Arturo Lopez Perez
City
Santiago
State/Province
Region Metropolitana
ZIP/Postal Code
7500921
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Clinica San Carlos de Apoquindo
City
Santiago
State/Province
Region Metropolitana
ZIP/Postal Code
7550000
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Anhui Provincial Hospital
City
Heifi
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Fujian Medical University - Fujian Provincial Cancer Hospital
City
Fuzhou
State/Province
Fuijan
ZIP/Postal Code
350014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Xiamen University - The First Affiliated Hospital
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
The Sixth Affiliated Hospital of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
1Affiliated H of Sun Yat Sen U
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hebei Medical Univ 4th Hosp
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
50010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450018
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Zhongnan univ Xiangya hosp
City
Changshan
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Jiangsu Province Hosp
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Liaoning Cancer Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
1st Hosp of China Medical Univ
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Shandong Cancer Hospital & Institute
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Zhongshan Hosp Fudan Univ
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Shanghai First People's Hosp
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Xinjiang Medical University - Cancer Hospital
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Zhejiang Medical University - Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Peking Univ 3rd Hosp
City
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
The 1st Hospital of Jilin Univ
City
Changchun
ZIP/Postal Code
130031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Sir Run Run Shaw Hospital
City
Hangzhou
ZIP/Postal Code
310018
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Linyi Cancer Hospital
City
Linyi
ZIP/Postal Code
276000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
1 Affiliated H of Nanchang U
City
Nanchang
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Fudan University - Shanghai Cancer Center
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
CHU Besançon
City
Besancon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
CHRU
City
Brest
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Centre Leon Berard
City
Lyon Cedex 08
ZIP/Postal Code
69373
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Hopital de la Timone
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Institut de Recherche en Cancerologie de Montpellier IRCM
City
Montpellier
ZIP/Postal Code
34298
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
L Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hopital Europeen G. Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Centre Hospitalier Universitaire CHU de Rennes - Hopital de Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Pharmacie ICLN
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42270
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Gustave Roussy, étage -1.
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Charité-Unimedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Uniklinikum Carl-Gustav-Carus
City
Dresden Sachsen
ZIP/Postal Code
1307
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Evang. Klin. Essen-Mitte gGmbH
City
Essen
ZIP/Postal Code
45136
Country
Germany
Individual Site Status
Terminated
Facility Name
Ins. für klinische onk. Forschung
City
Frankfurt Am Main Hessen
ZIP/Postal Code
60488
Country
Germany
Individual Site Status
Terminated
Facility Name
Häm-Onk. Praxis Eppendorf
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Individual Site Status
Terminated
Facility Name
Asklepios Tumorzentrum Altona
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Individual Site Status
Terminated
Facility Name
Uni zu Koln-Unikl. Koln
City
Kln Nordrhein-westfalen
ZIP/Postal Code
D-50937
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Universitares Krebszentrum
City
Leipzig
ZIP/Postal Code
4103
Country
Germany
Individual Site Status
Terminated
Facility Name
Pamela Youde Nethersole Eastern Hospital
City
Chai Wan
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Princess Margaret Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
The Chinese University of Hong Kong (CUHK) - Prince of Wales Hospital (PWH) - Vascular and Interventional Radiology Foundation (VIRF) Clinical Science Centre
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Magyar Honvedseg Egeszs. K
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Debreceni Egyetem Klinikai
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Terminated
Facility Name
Tolna M. Balassa Janos Korhaz
City
Szekszard
ZIP/Postal Code
7100
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Cork University Hospital
City
Cork
Country
Ireland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Tallaght University Hospital
City
Dublin
ZIP/Postal Code
4835-044
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Beaumont Hospital
City
Dublin
ZIP/Postal Code
5000-508
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
St James's Hospital
City
Dublin
ZIP/Postal Code
Dublin 8
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Soroka Univ Medical CTR
City
Be'er-Sheva Southern
ZIP/Postal Code
84101
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Davidoff Center
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
The Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
AOU Pisana
City
Barone
ZIP/Postal Code
56162
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Facility Name
IRCC-FPO Candiolo
City
Candiolo
ZIP/Postal Code
10060
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
AOU Mater Domini
City
Lopreiato
ZIP/Postal Code
88100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
San Raffaele Hospital
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Istituto Nazionale dei Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Istituto Europeo di Oncologia S.r.L Divisione di Oncologia Medica Gastrointestinale e Tumori Neuroendocrini
City
Milan
ZIP/Postal Code
20142
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Ospedale Niguarda
City
Milan
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Istituto Oncologico Veneto
City
Padua
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Azienda Ospedaliero-Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Aou Vanvitelli
City
Renato
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Aichi Cancer Center Hospital
City
Nagoya-shi
State/Province
Aichia
ZIP/Postal Code
464-8681
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Facility Name
National Cancer Center Hospital
City
Chuo Ku
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Osaka International Cancer Institute
City
Chuo Ku
ZIP/Postal Code
541-8567
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Facility Name
Gifu University Hospital
City
Gifu
ZIP/Postal Code
501-1194
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
National Cancer Center Hospital East
City
Kashiwa
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Kobe City Medical Center General Hospital
City
Kobe
ZIP/Postal Code
650-0047
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Facility Name
Kochi Health Sciences Center
City
Kochi
ZIP/Postal Code
781-8555
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Facility Name
The Cancer Institute Hospital of JFCR
City
Koto-Ku
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
National Hospital Organization Shikoku Cancer Center
City
Matsuyama
ZIP/Postal Code
791-0280
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Facility Name
Niigata Cancer Center Hospital
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Facility Name
Osaka University Hospital
City
Suita
ZIP/Postal Code
565-0871
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Facility Name
Kindai University Hospital
City
Ōsaka-sayama
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Kyungpook Nat Uni Chilgok Hos
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
ZIP/Postal Code
58128
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Seoul Nati Univ Bundang Hosp
City
Seongnam
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Korea Univ Anam Hosp
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Seoul St. Marys Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Chonbuk National University Hospital - Jeonbuk Regional Cancer Center
City
Seoul
ZIP/Postal Code
54907
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Sklodowska-Curie Inst Oncology
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Uniwersytecki Szpital Kliniczny im.Mikulicza-Radeckiego
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hospital Sra da Oliveira
City
Creixomil E Mariz
ZIP/Postal Code
4200-072
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil, E.P.E.
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
C Hosp Tras Montes Alto Douro
City
Vila Real
ZIP/Postal Code
D24 NR0A
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
S.C. Oncopremium-Team SRL
City
Baia Mare
ZIP/Postal Code
430295
Country
Romania
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Institutul Oncologic Prof. Dr. Alexandru Trestiorean Bucuresti IOB
City
Bucharest
ZIP/Postal Code
22328
Country
Romania
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
S.C. Medisprof SRL
City
Cluj-Napoca
ZIP/Postal Code
400641
Country
Romania
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Centrul de Oncologie Sf. Nectarie
City
Craiova
ZIP/Postal Code
200542
Country
Romania
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
SBIH Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
City Clinical Oncology Dispensary
City
Saint-Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Private Medical Institution "Euromedservice"
City
St.Petersburg
ZIP/Postal Code
196604
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Republican Clinical Oncology Dispensary
City
Ufa
ZIP/Postal Code
450054
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
National Univ Cancer Inst SGP
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
National Cancer Centre Singapore
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Hospital Germans Trias i Pujol
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
H. Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Hosp Univ Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Hospital de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Hospital Clinico Universitario de Santiago de Compostela
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
H. Clinico U. de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
KMUH
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
CGMF-Kaohsiung Branch
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
China Medical Univ Hosp
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
National Cheng Kung Univ Hosp
City
Tainan
ZIP/Postal Code
70457
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
National Taiwan University Hospital NTUH
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
MacKay Memorial Hospital
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan
Individual Site Status
Terminated
Facility Name
Taipei Veterans General Hosp
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
CGMF-Linkou Branch
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
SBU Adana Sehir Hastanesi
City
Adana
ZIP/Postal Code
1330
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Trakya Universitesi Balkan
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Suleyman Yalcin Seh. Hast.
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Inonu Uni. Turgut Ozal Tip
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
National Cancer Institute
City
Kyiv
ZIP/Postal Code
3022
Country
Ukraine
Individual Site Status
Terminated
Facility Name
MedicalCenter ASKLEPION LLC
City
Kyiv
ZIP/Postal Code
8173
Country
Ukraine
Individual Site Status
Terminated
Facility Name
LLC "Oncolife"
City
Zaporizhzhia
ZIP/Postal Code
69059
Country
Ukraine
Individual Site Status
Terminated
Facility Name
Queens University Belfast - Centre for Cancer Research and Cell Biology CCRCB
City
Belfast
ZIP/Postal Code
BT9 7BL
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
University Hospitals Birmingham UHB NHS Foundation Trust - Queen Elizabeth Hospital Birmingham QEHB
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Velindre NHS Trust - Velindre Cancer Centre VCC
City
Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Ninewells Hospital
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
The Clatterbridge Cancer Centre NHS Foundation Trust
City
Liverpool
ZIP/Postal Code
L9 7BA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
UCLH Trust
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Royal Marsden NHS
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Christie Hospital
City
Manchester
ZIP/Postal Code
8759
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
University of Oxford, The Churchill Hospital
City
Oxford
ZIP/Postal Code
OX3 7DQ
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Facility Name
Royal Marsden Sutton
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Leeds Teaching Hospitals NHS Trust
City
West Yorkshire
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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/
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://vivli.org/ourmember/daiichi-sankyo/

Learn more about this trial

Trastuzumab Deruxtecan for Subjects With HER2-Positive Gastric Cancer or Gastro-Esophageal Junction Adenocarcinoma After Progression on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04)

We'll reach out to this number within 24 hrs