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AzTrials

Gastric Cancer, AdenocarcinomaPhase 3NCT04704934

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 study testing Trastuzumab deruxtecan, Ramucirumab and Paclitaxel in people with Gastric Cancer, Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Daiichi Sankyo at 156 sites in 24 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Trastuzumab deruxtecan, Ramucirumab and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
490 participants
Where
156 sitesin 24 countries
Study dates
21 May 2021to 31 Aug 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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

Trial locations and contacts

156 sites in 24 countries.

156 sites in 24 countries

China24 sites

  • Beijing Cancer Hospital

    Beijing, 100142

  • Peking Univ 3rd Hosp

    Beijing, 100191

  • The 1st Hospital of Jilin Univ

    Changchun, 130031

  • Zhongnan univ Xiangya hosp

    Changshan, Hunan, 410008

  • Fujian Medical University - Fujian Provincial Cancer Hospital

    Fuzhou, Fuijan, 350014

  • The Sixth Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong, 510655

  • 1Affiliated H of Sun Yat Sen U

    Guangzhou, Guangdong

  • Zhejiang Medical University - Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Sir Run Run Shaw Hospital

    Hangzhou, 310018

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

  • Anhui Provincial Hospital

    Heifi, Anhui, 230001

  • Shandong Cancer Hospital & Institute

    Jinan, Shandong, 250117

  • Linyi Cancer Hospital

    Linyi, 276000

  • 1 Affiliated H of Nanchang U

    Nanchang, 330006

  • Jiangsu Province Hosp

    Nanjing, Jiangsu

  • Zhongshan Hosp Fudan Univ

    Shanghai, Shanghai Municipality, 200000

  • Shanghai First People's Hosp

    Shanghai, Shanghai Municipality, 200080

  • Fudan University - Shanghai Cancer Center

    Shanghai

  • Liaoning Cancer Hospital

    Shenyang, Liaoning, 110042

  • 1st Hosp of China Medical Univ

    Shenyang, Liaoning

  • Hebei Medical Univ 4th Hosp

    Shijiazhuang, Hebei, 50010

  • Xinjiang Medical University - Cancer Hospital

    Ürümqi, Xinjiang, 830000

  • Xiamen University - The First Affiliated Hospital

    Xiamen, Fujian, 361003

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450018

Other trials in China

Japan12 sites

  • National Cancer Center Hospital

    Chūōku, 104-0045

  • Osaka International Cancer Institute

    Chūōku, 541-8567

  • Gifu University Hospital

    Gifu, 501-1194

  • National Cancer Center Hospital East

    Kashiwa, 277-8577

  • Kobe City Medical Center General Hospital

    Kobe, 650-0047

  • Kochi Health Sciences Center

    Kochi, 781-8555

  • The Cancer Institute Hospital of JFCR

    Kōtoku, 135-8550

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, 791-0280

  • Aichi Cancer Center Hospital

    Nagoya, Aichia, 464-8681

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Kindai University Hospital

    Ōsaka-sayama, 589-8511

  • Osaka University Hospital

    Suita, 565-0871

Other trials in Japan

United Kingdom12 sites

  • University Hospitals Birmingham UHB NHS Foundation Trust - Queen Elizabeth Hospital Birmingham QEHB

    Birmingham, B15 2TH

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ

  • Velindre NHS Trust - Velindre Cancer Centre VCC

    Cardiff, CF14 2TL

  • Ninewells Hospital

    Dundee, DD1 9SY

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Liverpool, L9 7BA

  • UCLH Trust

    London, NW1 2PG

  • Royal Marsden NHS

    London, SW3 6JJ

  • Christie Hospital

    Manchester, 8759

  • University of Oxford, The Churchill Hospital

    Oxford, OX3 7DQ

  • Royal Marsden Sutton

    Sutton, SM2 5PT

  • Leeds Teaching Hospitals NHS Trust

    West Yorkshire, LS9 7TF

Other trials in United Kingdom

France11 sites

  • CHU Besançon

    Besançon, 25000

  • CHRU

    Brest, 29200

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Leon Berard

    Lyon, 69373

  • Hopital de la Timone

    Marseille, 13005

  • Institut de Recherche en Cancerologie de Montpellier IRCM

    Montpellier, 34298

  • Hopital Saint Antoine

    Paris, 75012

  • L Institut Mutualiste Montsouris

    Paris, 75014

  • Hopital Europeen G. Pompidou

    Paris, 75015

  • Pharmacie ICLN

    Saint-Priest-en-Jarez, 42270

  • Gustave Roussy, étage -1.

    Villejuif, 94800

Other trials in France

Italy11 sites

  • AOU Pisana

    Barone, 56162

  • IRCC-FPO Candiolo

    Candiolo, 10060

  • AOU Mater Domini

    Catanzaro, 88100

  • Istituto Europeo di Oncologia S.r.L Divisione di Oncologia Medica Gastrointestinale e Tumori Neuroendocrini

    Milan, 20142

  • Ospedale Niguarda

    Milan, 20162

  • San Raffaele Hospital

    Milan, 20132

  • Istituto Nazionale dei Tumori

    Milan, 20133

  • Azienda Ospedaliero-Universitaria di Modena

    Modena

  • Aou Vanvitelli

    Naples, 80131

  • Istituto Oncologico Veneto

    Padua, 35128

  • Azienda Ospedaliero-Universitaria Pisana

    Pisa, 56126

Other trials in Italy

South Korea10 sites

  • Kyungpook Nat Uni Chilgok Hos

    Daegu, 41404

  • Chonnam National University Hwasun Hospital

    Hwasun, 58128

  • Seoul Nati Univ Bundang Hosp

    Seongnam, 13620

  • Korea Univ Anam Hosp

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Seoul St. Marys Hospital

    Seoul, 06591

  • Chonbuk National University Hospital - Jeonbuk Regional Cancer Center

    Seoul, 54907

Other trials in South Korea

Spain9 sites

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Germans Trias i Pujol

    Barcelona, 08916

  • H. Gregorio Maranon

    Madrid, 28007

  • Hosp Univ Ramón y Cajal

    Madrid, 28034

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital de Navarra

    Pamplona, 31008

  • Hospital Clinico Universitario de Santiago de Compostela

    Santiago de Compostela, 15706

  • H. Clinico U. de Valencia

    Valencia, 46010

Other trials in Spain

Germany8 sites

  • Charité-Unimedizin Berlin

    Berlin, 13353

  • Uniklinikum Carl-Gustav-Carus

    Dresden Sachsen, 1307

  • Evang. Klin. Essen-Mitte gGmbH

    Essen, 45136

  • Ins. für klinische onk. Forschung

    Frankfurt Am Main Hessen, 60488

  • Häm-Onk. Praxis Eppendorf

    Hamburg, 20249

  • Asklepios Tumorzentrum Altona

    Hamburg, 22763

  • Uni zu Koln-Unikl. Koln

    Kln Nordrhein-westfalen, D-50937

  • Universitares Krebszentrum

    Leipzig, 4103

Other trials in Germany

Taiwan8 sites

  • KMUH

    Kaohsiung City, 80756

  • CGMF-Kaohsiung Branch

    Kaohsiung City, 83301

  • China Medical Univ Hosp

    Taichung, 40447

  • National Cheng Kung Univ Hosp

    Tainan, 70457

  • National Taiwan University Hospital NTUH

    Taipei, 10048

  • MacKay Memorial Hospital

    Taipei, 10449

  • Taipei Veterans General Hosp

    Taipei, 11217

  • CGMF-Linkou Branch

    Taoyuan, 33305

Other trials in Taiwan

Argentina4 sites

  • Fundacion Cenit

    Buenos Aires, C1125 ABD

  • Instituto Medico Especializado Alexander Fleming

    Colegiales, Buenos Aires F.D., C1426

  • IONC Instituto Oncologico de Cordoba - Fundacion Richardet Longo

    Nueva Cordoba, Córdoba Province, 5000

  • Exelsus

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Belgium4 sites

  • UCL St. Luc

    Brussels, 1200

  • Antwerp University Hospital

    Edegem, 2650

  • Pôle Hospitalier Jolimont

    Haine-Saint-Paul, 7100

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Brazil4 sites

  • PERSONAL - Oncologia de Precisao e Personalizada

    Belo Horizonte, 30130-090

  • Hospital Sirio Libanes

    Brasília, 70200-730

  • ONCOSITE - Centro de Pesquisa Clinica em Oncologia LTDA

    Ijuí, 98700-000

  • Hospital Ernesto Dornelles

    Porto Alegre, 90160-092

Other trials in Brazil

Hong Kong4 sites

  • Pamela Youde Nethersole Eastern Hospital

    Chai Wan

  • Princess Margaret Hospital

    Hong Kong

  • Queen Mary Hospital

    Hong Kong

  • The Chinese University of Hong Kong (CUHK) - Prince of Wales Hospital (PWH) - Vascular and Interventional Radiology Foundation (VIRF) Clinical Science Centre

    Hong Kong

Other trials in Hong Kong

Ireland4 sites

  • Cork University Hospital

    Cork

  • Tallaght University Hospital

    Dublin, 4835-044

  • Beaumont Hospital

    Dublin, 5000-508

  • St James's Hospital

    Dublin, Dublin 8

Other trials in Ireland

Romania4 sites

  • S.C. Oncopremium-Team SRL

    Baia Mare, 430295

  • Institutul Oncologic Prof. Dr. Alexandru Trestiorean Bucuresti IOB

    Bucharest, 22328

  • S.C. Medisprof SRL

    Cluj-Napoca, 400641

  • Centrul de Oncologie Sf. Nectarie

    Craiova, 200542

Other trials in Romania

Russia4 sites

  • SBIH Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine

    Chelyabinsk, 454087

  • Private Medical Institution "Euromedservice"

    Saint Petersburg, 196604

  • City Clinical Oncology Dispensary

    Saint Petersburg, 198255

  • Republican Clinical Oncology Dispensary

    Ufa, 450054

Other trials in Russia

Turkey (Türkiye)4 sites

  • SBU Adana Sehir Hastanesi

    Adana, 1330

  • Trakya Universitesi Balkan

    Edirne, 22030

  • Suleyman Yalcin Seh. Hast.

    Istanbul, 34722

  • Inonu Uni. Turgut Ozal Tip

    Malatya, 44280

Other trials in Turkey (Türkiye)

Chile3 sites

  • Fundacion Arturo Lopez Perez

    Santiago, Santiago Metropolitan, 7500921

  • Clinica San Carlos de Apoquindo

    Santiago, Santiago Metropolitan, 7550000

  • SIM Centro de Investigacion Clinica

    Temuco, Cautin, 4810469

Other trials in Chile

Hungary3 sites

  • Magyar Honvedseg Egeszs. K

    Budapest, 1062

  • Debreceni Egyetem Klinikai

    Debrecen, 4032

  • Tolna M. Balassa Janos Korhaz

    Szekszárd, 7100

Other trials in Hungary

Israel3 sites

  • Soroka Univ Medical CTR

    Be'er-Sheva Southern, 84101

  • Davidoff Center

    Petah Tikva, 49100

  • The Chaim Sheba Medical Center

    Ramat Gan, 5265601

Other trials in Israel

Portugal3 sites

  • Hospital Sra da Oliveira

    Creixomil E Mariz, 4200-072

  • Instituto Portugues De Oncologia Do Porto Francisco Gentil, E.P.E.

    Porto, 4200-072

  • C Hosp Tras Montes Alto Douro

    Vila Real, D24 NR0A

Other trials in Portugal

Ukraine3 sites

  • National Cancer Institute

    Kyiv, 3022

  • MedicalCenter ASKLEPION LLC

    Kyiv, 8173

  • LLC "Oncolife"

    Zaporizhzhya, 69059

Other trials in Ukraine

Poland2 sites

  • Sklodowska-Curie Inst Oncology

    Warsaw, 02-781

  • Uniwersytecki Szpital Kliniczny im.Mikulicza-Radeckiego

    Wroclaw, 50-556

Other trials in Poland

Singapore2 sites

  • National Univ Cancer Inst SGP

    Singapore, 119228

  • National Cancer Centre Singapore

    Singapore, 169610

Other trials in Singapore

About this study

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)

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.

Read the 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.

Being tested
Trastuzumab deruxtecan, Ramucirumab, Paclitaxel
Keywords
Gastric Cancer, Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Trastuzumab deruxtecan, T-DXd, DS-8201a, Ramucirumab, Paclitaxel
Medical subject headings
Stomach Neoplasms, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trastuzumab deruxtecanDrug

    Also called T-DXd, DS-8201a, ENHERTU®

    6.4 mg/kg IV infusion every 3 weeks on Day 1 of each 21-day cycle

  • RamucirumabDrug

    Also called CYRAMZA®

    8 mg/kg IV infusion on Days 1 and 15 of a 28-day cycle

  • PaclitaxelDrug

    80 mg/m^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle

Study groups in NCT04704934
Study groupRoleWhat they receive
Trastuzumab deruxtecanExperimentalParticipants 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.
Receives: Drug: Trastuzumab deruxtecan
Ramucirumab + paclitaxelActive comparatorParticipants 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.
Receives: Drug: Ramucirumab; Drug: Paclitaxel

What is being measured

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

  1. 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.

    Measured: Time from date of randomization until death (due to any cause), up to approximately 36 months

Secondary outcomes (8)

  1. 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.

    Measured: 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

  2. 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.

    Measured: From start of treatment to date of documented disease progression, up to approximately 36 months

  3. 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.

    Measured: 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

  4. 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.

    Measured: From start of treatment to date of documented disease progression, up to approximately 36 months

  5. 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.

    Measured: From time subjects signs informed consent form up to 40 days after last study dose

  6. Serum Concentrations for Trastuzumab Deruxtecan, total anti-HER2 antibody, and Active Metabolite MAAA-1181a

    Measured: Cycles 1-4 and subsequent cycles on Day 1 pre- and post-infusion (each cycle is 28 days)

  7. Percentage of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline)

    The immunogenicity of trastuzumab deruxtecan will be assessed.

    Measured: 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)

  8. Percentage of Participants Who Have Treatment-emergent ADAs

    The immunogenicity of trastuzumab deruxtecan will be assessed.

    Measured: 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)

Timeline

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

  1. First posted12 Jan 2021
  2. Study start21 May 2021
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion31 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
490 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04704934
Sponsor's protocol ID
DS8201-A-U306
Other IDs
2020-004559-34
Status last verified
May 2026
First submitted
8 Jan 2021
Last updated
27 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Publications

  • 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.

    PubMed 40454632

  • 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.

    PubMed 40341124

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trastuzumab deruxtecan, Ramucirumab and Paclitaxel in people with Gastric Cancer, Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Daiichi Sankyo at 156 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 156 sites in China, Japan, United Kingdom, France, Italy and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival in Participants Who Were Administered Trastuzumab Deruxtecan Compared With Ramucirumab in Combination With Paclitaxel (time frame: Time from date of randomization until death (due to any cause), up to approximately 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04704934, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.

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