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)

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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Gastroesophageal Junction Adenocarcinoma; Gastric Cancer, Adenocarcinoma
• Intervention / Treatment: Drug: Trastuzumab deruxtecan; Drug: Ramucirumab; Drug: Paclitaxel

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.

• Study Type: Interventional
• Enrollment (Estimated): 490
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1125 ABD
    • Fundacion Cenit
  • Buenos Aires F.D.
    • Colegiales, Buenos Aires F.D., Argentina, C1426
      • Instituto Medico Especializado Alexander Fleming
  • Córdoba Province
    • Nueva Cordoba, Córdoba Province, Argentina, 5000
      • IONC Instituto Oncologico de Cordoba - Fundacion Richardet Longo
  • Tucumán Province
    • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
      • Exelsus
• Belgium
  • Brussels, Belgium, 1200
    • UCL St. Luc
  • Edegem, Belgium, 2650
    • Antwerp University Hospital
  • Haine-Saint-Paul, Belgium, 7100
    • Pôle Hospitalier Jolimont
  • Leuven, Belgium, 3000
    • UZ Leuven
• Brazil
  • Belo Horizonte, Brazil, 30130-090
    • PERSONAL - Oncologia de Precisao e Personalizada
  • Brasília, Brazil, 70200-730
    • Hospital Sirio Libanes
  • Ijuí, Brazil, 98700-000
    • Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
  • Porto Alegre, Brazil, 90160-092
    • Hospital Ernesto Dornelles
• Chile
  • Cautin
    • Temuco, Cautin, Chile, 4810469
      • SIM Centro de Investigacion Clinica
  • Santiago Metropolitan
    • Santiago, Santiago Metropolitan, Chile, 7500921
      • Fundacion Arturo Lopez Perez
    • Santiago, Santiago Metropolitan, Chile, 7550000
      • Clinica San Carlos de Apoquindo
• China
  • Beijing, China, 100142
    • Beijing Cancer Hospital
  • Beijing, China, 100191
    • Peking Univ 3rd Hosp
  • Changchun, China, 130031
    • The 1st Hospital of Jilin Univ
  • Hangzhou, China, 310018
    • Sir Run Run Shaw Hospital
  • Linyi, China, 276000
    • Linyi Cancer Hospital
  • Nanchang, China, 330006
    • 1 Affiliated H of Nanchang U
  • Shanghai, China
    • Fudan University - Shanghai Cancer Center
  • Anhui
    • Heifi, Anhui, China, 230001
      • Anhui Provincial Hospital
  • Fuijan
    • Fuzhou, Fuijan, China, 350014
      • Fujian Medical University - Fujian Provincial Cancer Hospital
  • Fujian
    • Xiamen, Fujian, China, 361003
      • Xiamen University - The First Affiliated Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510655
      • The Sixth Affiliated Hospital of Sun Yat-sen University
    • Guangzhou, Guangdong, China
      • 1Affiliated H of Sun Yat Sen U
  • Hebei
    • Shijiazhuang, Hebei, China, 50010
      • Hebei Medical Univ 4th Hosp
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Harbin medical university cancer hospital
  • Henan
    • Zhengzhou, Henan, China, 450018
      • The first affiliated hospital of Zhengzhou university
  • Hunan
    • Changshan, Hunan, China, 410008
      • Zhongnan univ Xiangya hosp
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Jiangsu Province Hosp
  • Liaoning
    • Shenyang, Liaoning, China, 110042
      • Liaoning Cancer Hospital
    • Shenyang, Liaoning, China
      • 1st Hosp of China Medical Univ
  • Shandong
    • Jinan, Shandong, China, 250117
      • Shandong Cancer Hospital & Institute
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200000
      • Zhongshan Hosp Fudan Univ
    • Shanghai, Shanghai Municipality, China, 200080
      • Shanghai First People's Hosp
  • Xinjiang
    • Ürümqi, Xinjiang, China, 830000
      • Xinjiang Medical University - Cancer Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Medical University - Zhejiang Cancer Hospital
• France
  • Besançon, France, 25000
    • CHU Besançon
  • Brest, France, 29200
    • CHRU
  • Lille, France, 59020
    • Centre Oscar Lambret
  • Lyon, France, 69373
    • Centre Léon Bérard
  • Marseille, France, 13005
    • Hopital de la Timone
  • Montpellier, France, 34298
    • Institut de Recherche en Cancerologie de Montpellier IRCM
  • Paris, France, 75012
    • Hopital Saint Antoine
  • Paris, France, 75014
    • L Institut Mutualiste Montsouris
  • Paris, France, 75015
    • Hopital Europeen G. Pompidou
  • Saint-Priest-en-Jarez, France, 42270
    • Pharmacie ICLN
  • Villejuif, France, 94800
    • Gustave Roussy, étage -1.
• Germany
  • Berlin, Germany, 13353
    • Charité-Unimedizin Berlin
  • Dresden Sachsen, Germany, 1307
    • Uniklinikum Carl-Gustav-Carus
  • Essen, Germany, 45136
    • Evang. Klin. Essen-Mitte gGmbH
  • Frankfurt Am Main Hessen, Germany, 60488
    • Ins. für klinische onk. Forschung
  • Hamburg, Germany, 20249
    • Häm-Onk. Praxis Eppendorf
  • Hamburg, Germany, 22763
    • Asklepios Tumorzentrum Altona
  • Kln Nordrhein-westfalen, Germany, D-50937
    • Uni zu Koln-Unikl. Koln
  • Leipzig, Germany, 4103
    • Universitares Krebszentrum
• Hong Kong
  • Chai Wan, Hong Kong
    • Pamela Youde Nethersole Eastern Hospital
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
  • Hong Kong, Hong Kong
    • Princess Margaret Hospital
  • Hong Kong, Hong Kong
    • The Chinese University of Hong Kong (CUHK) - Prince of Wales Hospital (PWH) - Vascular and Interventional Radiology Foundation (VIRF) Clinical Science Centre
• Hungary
  • Budapest, Hungary, 1062
    • Magyar Honvedseg Egeszs. K
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai
  • Szekszárd, Hungary, 7100
    • Tolna M. Balassa Janos Korhaz
• Ireland
  • Cork, Ireland
    • Cork University Hospital
  • Dublin, Ireland, Dublin 8
    • St James's Hospital
  • Dublin, Ireland, 4835-044
    • Tallaght University Hospital
  • Dublin, Ireland, 5000-508
    • Beaumont Hospital
• Israel
  • Be'er-Sheva Southern, Israel, 84101
    • Soroka Univ Medical CTR
  • Petah Tikva, Israel, 49100
    • Davidoff Center
  • Ramat Gan, Israel, 5265601
    • The Chaim Sheba Medical Center
• Italy
  • Barone, Italy, 56162
    • AOU Pisana
  • Candiolo, Italy, 10060
    • IRCC-FPO Candiolo
  • Catanzaro, Italy, 88100
    • AOU Mater Domini
  • Milan, Italy, 20132
    • San Raffaele Hospital
  • Milan, Italy, 20133
    • Istituto Nazionale dei Tumori
  • Milan, Italy, 20162
    • Ospedale Niguarda
  • Milan, Italy, 20142
    • Istituto Europeo di Oncologia S.r.L Divisione di Oncologia Medica Gastrointestinale e Tumori Neuroendocrini
  • Modena, Italy
    • Azienda Ospedaliero-Universitaria di Modena
  • Naples, Italy, 80131
    • Aou Vanvitelli
  • Padua, Italy, 35128
    • Istituto Oncologico Veneto
  • Pisa, Italy, 56126
    • Azienda Ospedaliero-Universitaria Pisana
• Japan
  • Chūōku, Japan, 104-0045
    • National Cancer Center Hospital
  • Chūōku, Japan, 541-8567
    • Osaka International Cancer Institute
  • Gifu, Japan, 501-1194
    • Gifu University Hospital
  • Kashiwa, Japan, 277-8577
    • National Cancer Center Hospital East
  • Kobe, Japan, 650-0047
    • Kobe City Medical Center General Hospital
  • Kochi, Japan, 781-8555
    • Kochi Health Sciences Center
  • Kōtoku, Japan, 135-8550
    • The Cancer Institute Hospital of JFCR
  • Matsuyama, Japan, 791-0280
    • National Hospital Organization Shikoku Cancer Center
  • Niigata, Japan, 951-8566
    • Niigata Cancer Center Hospital
  • Suita, Japan, 565-0871
    • Osaka University Hospital
  • Ōsaka-sayama, Japan, 589-8511
    • Kindai University Hospital
  • Aichia
    • Nagoya, Aichia, Japan, 464-8681
      • Aichi Cancer Center Hospital
• Poland
  • Warsaw, Poland, 02-781
    • Sklodowska-Curie Inst Oncology
  • Wroclaw, Poland, 50-556
    • Uniwersytecki Szpital Kliniczny im.Mikulicza-Radeckiego
• Portugal
  • Creixomil E Mariz, Portugal, 4200-072
    • Hospital Sra da Oliveira
  • Porto, Portugal, 4200-072
    • Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
  • Vila Real, Portugal, D24 NR0A
    • C Hosp Tras Montes Alto Douro
• Romania
  • Baia Mare, Romania, 430295
    • S.C. Oncopremium-Team SRL
  • Bucharest, Romania, 22328
    • Institutul Oncologic Prof. Dr. Alexandru Trestiorean Bucuresti IOB
  • Cluj-Napoca, Romania, 400641
    • S.C. Medisprof SRL
  • Craiova, Romania, 200542
    • Centrul de Oncologie Sf. Nectarie
• Russia
  • Chelyabinsk, Russia, 454087
    • SBIH Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine
  • Saint Petersburg, Russia, 196604
    • Private Medical Institution "Euromedservice"
  • Saint Petersburg, Russia, 198255
    • City Clinical Oncology Dispensary
  • Ufa, Russia, 450054
    • Republican Clinical Oncology Dispensary
• Singapore
  • Singapore, Singapore, 169610
    • National Cancer Centre Singapore
  • Singapore, Singapore, 119228
    • National Univ Cancer Inst SGP
• South Korea
  • Daegu, South Korea, 41404
    • Kyungpook Nat Uni Chilgok Hos
  • Hwasun, South Korea, 58128
    • Chonnam National University Hwasun Hospital
  • Seongnam, South Korea, 13620
    • Seoul Nati Univ Bundang Hosp
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 03722
    • Severance Hospital
  • Seoul, South Korea, 02841
    • Korea Univ Anam Hosp
  • Seoul, South Korea, 06591
    • Seoul St. Marys Hospital
  • Seoul, South Korea, 54907
    • Chonbuk National University Hospital - Jeonbuk Regional Cancer Center
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 08035
    • Hospital Vall d'Hebron
  • Barcelona, Spain, 08916
    • Hospital Germans Trias i Pujol
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28007
    • H. Gregorio Marañón
  • Madrid, Spain, 28034
    • Hosp Univ Ramón y Cajal
  • Pamplona, Spain, 31008
    • Hospital de Navarra
  • Santiago de Compostela, Spain, 15706
    • Hospital Clínico Universitario de Santiago de Compostela
  • Valencia, Spain, 46010
    • H. Clinico U. de Valencia
• Taiwan
  • Kaohsiung City, Taiwan, 80756
    • KMUH
  • Kaohsiung City, Taiwan, 83301
    • CGMF-Kaohsiung Branch
  • Taichung, Taiwan, 40447
    • China Medical Univ Hosp
  • Tainan, Taiwan, 70457
    • National Cheng Kung Univ Hosp
  • Taipei, Taiwan, 10449
    • Mackay Memorial Hospital
  • Taipei, Taiwan, 10048
    • National Taiwan University Hospital NTUH
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hosp
  • Taoyuan, Taiwan, 33305
    • CGMF-Linkou Branch
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 1330
    • SBU Adana Sehir Hastanesi
  • Edirne, Turkey (Türkiye), 22030
    • Trakya Universitesi Balkan
  • Istanbul, Turkey (Türkiye), 34722
    • Suleyman Yalcin Seh. Hast.
  • Malatya, Turkey (Türkiye), 44280
    • Inonu Uni. Turgut Ozal Tip
• Ukraine
  • Kyiv, Ukraine, 3022
    • National Cancer Institute
  • Kyiv, Ukraine, 8173
    • MedicalCenter ASKLEPION LLC
  • Zaporizhzhia, Ukraine, 69059
    • LLC "Oncolife"
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • University Hospitals Birmingham UHB NHS Foundation Trust - Queen Elizabeth Hospital Birmingham QEHB
  • Cambridge, United Kingdom, CB2 0QQ
    • Addenbrooke's Hospital
  • Cardiff, United Kingdom, CF14 2TL
    • Velindre NHS Trust - Velindre Cancer Centre VCC
  • Dundee, United Kingdom, DD1 9SY
    • Ninewells Hospital
  • Glasgow, United Kingdom, G12 0YN
    • Beatson West Of Scotland Cancer Centre
  • Liverpool, United Kingdom, L9 7BA
    • The Clatterbridge Cancer Centre NHS Foundation Trust
  • London, United Kingdom, NW1 2PG
    • UCLH Trust
  • London, United Kingdom, SW3 6JJ
    • Royal Marsden NHS
  • Manchester, United Kingdom, 8759
    • Christie Hospital
  • Oxford, United Kingdom, OX3 7DQ
    • University of Oxford, The Churchill Hospital
  • Sutton, United Kingdom, SM2 5PT
    • Royal Marsden Sutton
  • West Yorkshire, United Kingdom, LS9 7TF
    • Leeds Teaching Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trastuzumab deruxtecan; 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.	Drug: Trastuzumab deruxtecan; 6.4 mg/kg IV infusion every 3 weeks on Day 1 of each 21-day cycle; Other Names: DS-8201a; T-DXd; ENHERTU®
Active Comparator: Ramucirumab + paclitaxel; 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.	Drug: Ramucirumab; 8 mg/kg IV infusion on Days 1 and 15 of a 28-day cycle; Other Names: CYRAMZA®; Drug: Paclitaxel; 80 mg/m^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Time from date of randomization until death (due to any cause), up to approximately 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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
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.	From start of treatment to date of documented disease progression, up to approximately 36 months
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.	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
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.	From start of treatment to date of documented disease progression, up to approximately 36 months
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.	From time subjects signs informed consent form up to 40 days after last study dose
Serum Concentrations for Trastuzumab Deruxtecan, total anti-HER2 antibody, and Active Metabolite MAAA-1181a		Cycles 1-4 and subsequent cycles on Day 1 pre- and post-infusion (each cycle is 28 days)
Percentage of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline)	The immunogenicity of trastuzumab deruxtecan will be assessed.	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)
Percentage of Participants Who Have Treatment-emergent ADAs	The immunogenicity of trastuzumab deruxtecan will be assessed.	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)

Collaborators and Investigators

• Sponsor: Daiichi Sankyo
• Collaborators: AstraZeneca
• Investigators: Study Director: Global Clinical Leader, Daiichi Sankyo

Publications and helpful links

General Publications

• Shitara K, Van Cutsem E, Gumus M, Lonardi S, de la Fouchardiere C, Coutzac C, Dekervel J, Hochhauser D, Shen L, Mansoor W, Liu B, Fornaro L, Ryu MH, Lee J, Faustino C, Metges JP, Tabernero J, Franke F, Janjigian YY, Souza F, Jukofsky L, Zhao Y, Kamio T, Zaanan A, Pietrantonio F; DESTINY-Gastric04 Trial Investigators. Trastuzumab Deruxtecan or Ramucirumab plus Paclitaxel in Gastric Cancer. N Engl J Med. 2025 Jul 24;393(4):336-348. doi: 10.1056/NEJMoa2503119. Epub 2025 May 31.
• Yu J, Mehta R. Biomarker-Driven Approach to the Treatment of Metastatic Gastric or Gastroesophageal Adenocarcinoma. J Natl Compr Canc Netw. 2025 May;23(5):e257036. doi: 10.6004/jnccn.2025.7036.

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2021
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: January 8, 2021
• First Posted (Actual): January 12, 2021

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Paclitaxel; Ramucirumab; DS-8201a; T-DXd; Trastuzumab deruxtecan; Gastroesophageal Junction Adenocarcinoma; Gastric Cancer, Adenocarcinoma
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Neoplasms, Glandular and Epithelial; Carcinoma; Stomach Neoplasms; Adenocarcinoma; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Diterpenes; Ramucirumab; Paclitaxel; trastuzumab deruxtecan
• Other Study ID Numbers: DS8201-A-U306; 2020-004559-34 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No