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New hope for stomach cancer: targeted drug shows promise in Late-Stage trial

NCT ID NCT04704934

Disease control Sponsor: Daiichi Sankyo Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial compares a newer targeted drug, trastuzumab deruxtecan, against a standard combination of two other drugs (ramucirumab and paclitaxel) in 490 adults with HER2-positive stomach or gastro-esophageal junction cancer that has worsened after initial treatment with trastuzumab. The main goal is to see if the newer drug helps people live longer. The study is active but no longer recruiting participants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
trastuzumab deruxtecan (also called T-DXd or Enhertu)
What this could lead to
If successful, this could offer a new treatment option for people with HER2-positive stomach cancer that has stopped responding to standard therapy, potentially extending survival.
What could go wrong
This is a phase 3 trial, but results are not yet available. The drug may not prove more effective than current treatments and can cause serious side effects like lung inflammation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 490 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2021

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

adenocarcinoma gastric adenocarcinoma gastric neoplasm gastroesophageal junction adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastric cancer, adenocarcinoma Gastroesophageal junction adenocarcinoma

Contacts and locations

Locations

  • 1 Affiliated H of Nanchang U

    Nanchang, 330006, China

  • 1Affiliated H of Sun Yat Sen U

    Guangzhou, Guangdong, China

  • 1st Hosp of China Medical Univ

    Shenyang, Liaoning, China

  • AOU Mater Domini

    Catanzaro, 88100, Italy

  • AOU Pisana

    Barone, 56162, Italy

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ, United Kingdom

  • Aichi Cancer Center Hospital

    Nagoya, Aichia, 464-8681, Japan

  • Anhui Provincial Hospital

    Heifi, Anhui, 230001, China

  • Antwerp University Hospital

    Edegem, 2650, Belgium

  • Aou Vanvitelli

    Naples, 80131, Italy

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Asklepios Tumorzentrum Altona

    Hamburg, 22763, Germany

  • Azienda Ospedaliero-Universitaria Pisana

    Pisa, 56126, Italy

  • Azienda Ospedaliero-Universitaria di Modena

    Modena, Italy

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN, United Kingdom

  • Beaumont Hospital

    Dublin, 5000-508, Ireland

  • Beijing Cancer Hospital

    Beijing, 100142, China

  • C Hosp Tras Montes Alto Douro

    Vila Real, D24 NR0A, Portugal

  • CGMF-Kaohsiung Branch

    Kaohsiung City, 83301, Taiwan

  • CGMF-Linkou Branch

    Taoyuan, 33305, Taiwan

  • CHRU

    Brest, 29200, France

  • CHU Besançon

    Besançon, 25000, France

  • Centre Leon Berard

    Lyon, 69373, France

  • Centre Oscar Lambret

    Lille, 59020, France

  • Centrul de Oncologie Sf. Nectarie

    Craiova, 200542, Romania

  • Charité-Unimedizin Berlin

    Berlin, 13353, Germany

  • China Medical Univ Hosp

    Taichung, 40447, Taiwan

  • Chonbuk National University Hospital - Jeonbuk Regional Cancer Center

    Seoul, 54907, South Korea

  • Chonnam National University Hwasun Hospital

    Hwasun, 58128, South Korea

  • Christie Hospital

    Manchester, 8759, United Kingdom

  • City Clinical Oncology Dispensary

    Saint Petersburg, 198255, Russia

  • Clinica San Carlos de Apoquindo

    Santiago, Santiago Metropolitan, 7550000, Chile

  • Cork University Hospital

    Cork, Ireland

  • Davidoff Center

    Petah Tikva, 49100, Israel

  • Debreceni Egyetem Klinikai

    Debrecen, 4032, Hungary

  • Evang. Klin. Essen-Mitte gGmbH

    Essen, 45136, Germany

  • Exelsus

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • Fudan University - Shanghai Cancer Center

    Shanghai, China

  • Fujian Medical University - Fujian Provincial Cancer Hospital

    Fuzhou, Fuijan, 350014, China

  • Fundacion Arturo Lopez Perez

    Santiago, Santiago Metropolitan, 7500921, Chile

  • Fundacion Cenit

    Buenos Aires, C1125 ABD, Argentina

  • Gifu University Hospital

    Gifu, 501-1194, Japan

  • Gustave Roussy, étage -1.

    Villejuif, 94800, France

  • H. Clinico U. de Valencia

    Valencia, 46010, Spain

  • H. Gregorio Maranon

    Madrid, 28007, Spain

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081, China

  • Hebei Medical Univ 4th Hosp

    Shijiazhuang, Hebei, 50010, China

  • Hopital Europeen G. Pompidou

    Paris, 75015, France

  • Hopital Saint Antoine

    Paris, 75012, France

  • Hopital de la Timone

    Marseille, 13005, France

  • Hosp Univ Ramón y Cajal

    Madrid, 28034, Spain

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Clinico Universitario de Santiago de Compostela

    Santiago de Compostela, 15706, Spain

  • Hospital Ernesto Dornelles

    Porto Alegre, 90160-092, Brazil

  • Hospital Germans Trias i Pujol

    Barcelona, 08916, Spain

  • Hospital Sirio Libanes

    Brasília, 70200-730, Brazil

  • Hospital Sra da Oliveira

    Creixomil E Mariz, 4200-072, Portugal

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital de Navarra

    Pamplona, 31008, Spain

  • Häm-Onk. Praxis Eppendorf

    Hamburg, 20249, Germany

  • IONC Instituto Oncologico de Cordoba - Fundacion Richardet Longo

    Nueva Cordoba, Córdoba Province, 5000, Argentina

  • IRCC-FPO Candiolo

    Candiolo, 10060, Italy

  • Inonu Uni. Turgut Ozal Tip

    Malatya, 44280, Turkey (Türkiye)

  • Ins. für klinische onk. Forschung

    Frankfurt Am Main Hessen, 60488, Germany

  • Institut de Recherche en Cancerologie de Montpellier IRCM

    Montpellier, 34298, France

  • Instituto Medico Especializado Alexander Fleming

    Colegiales, Buenos Aires F.D., C1426, Argentina

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

    Porto, 4200-072, Portugal

  • Institutul Oncologic Prof. Dr. Alexandru Trestiorean Bucuresti IOB

    Bucharest, 22328, Romania

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

    Milan, 20142, Italy

  • Istituto Nazionale dei Tumori

    Milan, 20133, Italy

  • Istituto Oncologico Veneto

    Padua, 35128, Italy

  • Jiangsu Province Hosp

    Nanjing, Jiangsu, China

  • KMUH

    Kaohsiung City, 80756, Taiwan

  • Kindai University Hospital

    Ōsaka-sayama, 589-8511, Japan

  • Kobe City Medical Center General Hospital

    Kobe, 650-0047, Japan

  • Kochi Health Sciences Center

    Kochi, 781-8555, Japan

  • Korea Univ Anam Hosp

    Seoul, 02841, South Korea

  • Kyungpook Nat Uni Chilgok Hos

    Daegu, 41404, South Korea

  • L Institut Mutualiste Montsouris

    Paris, 75014, France

  • LLC "Oncolife"

    Zaporizhzhia, 69059, Ukraine

  • Leeds Teaching Hospitals NHS Trust

    West Yorkshire, LS9 7TF, United Kingdom

  • Liaoning Cancer Hospital

    Shenyang, Liaoning, 110042, China

  • Linyi Cancer Hospital

    Linyi, 276000, China

  • MacKay Memorial Hospital

    Taipei, 10449, Taiwan

  • Magyar Honvedseg Egeszs. K

    Budapest, 1062, Hungary

  • MedicalCenter ASKLEPION LLC

    Kyiv, 8173, Ukraine

  • National Cancer Center Hospital

    Chūōku, 104-0045, Japan

  • National Cancer Center Hospital East

    Kashiwa, 277-8577, Japan

  • National Cancer Centre Singapore

    Singapore, 169610, Singapore

  • National Cancer Institute

    Kyiv, 3022, Ukraine

  • National Cheng Kung Univ Hosp

    Tainan, 70457, Taiwan

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, 791-0280, Japan

  • National Taiwan University Hospital NTUH

    Taipei, 10048, Taiwan

  • National Univ Cancer Inst SGP

    Singapore, 119228, Singapore

  • Niigata Cancer Center Hospital

    Niigata, 951-8566, Japan

  • Ninewells Hospital

    Dundee, DD1 9SY, United Kingdom

  • ONCOSITE - Centro de Pesquisa Clinica em Oncologia LTDA

    Ijuí, 98700-000, Brazil

  • Osaka International Cancer Institute

    Chūōku, 541-8567, Japan

  • Osaka University Hospital

    Suita, 565-0871, Japan

  • Ospedale Niguarda

    Milan, 20162, Italy

  • PERSONAL - Oncologia de Precisao e Personalizada

    Belo Horizonte, 30130-090, Brazil

  • Pamela Youde Nethersole Eastern Hospital

    Chai Wan, Hong Kong

  • Peking Univ 3rd Hosp

    Beijing, 100191, China

  • Pharmacie ICLN

    Saint-Priest-en-Jarez, 42270, France

  • Princess Margaret Hospital

    Hong Kong, Hong Kong

  • Private Medical Institution "Euromedservice"

    Saint Petersburg, 196604, Russia

  • Pôle Hospitalier Jolimont

    Haine-Saint-Paul, 7100, Belgium

  • Queen Mary Hospital

    Hong Kong, Hong Kong

  • Republican Clinical Oncology Dispensary

    Ufa, 450054, Russia

  • Royal Marsden NHS

    London, SW3 6JJ, United Kingdom

  • Royal Marsden Sutton

    Sutton, SM2 5PT, United Kingdom

  • S.C. Medisprof SRL

    Cluj-Napoca, 400641, Romania

  • S.C. Oncopremium-Team SRL

    Baia Mare, 430295, Romania

  • SBIH Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine

    Chelyabinsk, 454087, Russia

  • SBU Adana Sehir Hastanesi

    Adana, 1330, Turkey (Türkiye)

  • SIM Centro de Investigacion Clinica

    Temuco, Cautin, 4810469, Chile

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • San Raffaele Hospital

    Milan, 20132, Italy

  • Seoul Nati Univ Bundang Hosp

    Seongnam, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Seoul St. Marys Hospital

    Seoul, 06591, South Korea

  • Severance Hospital

    Seoul, 03722, South Korea

  • Shandong Cancer Hospital & Institute

    Jinan, Shandong, 250117, China

  • Shanghai First People's Hosp

    Shanghai, Shanghai Municipality, 200080, China

  • Sir Run Run Shaw Hospital

    Hangzhou, 310018, China

  • Sklodowska-Curie Inst Oncology

    Warsaw, 02-781, Poland

  • Soroka Univ Medical CTR

    Be'er-Sheva Southern, 84101, Israel

  • St James's Hospital

    Dublin, Dublin 8, Ireland

  • Suleyman Yalcin Seh. Hast.

    Istanbul, 34722, Turkey (Türkiye)

  • Taipei Veterans General Hosp

    Taipei, 11217, Taiwan

  • Tallaght University Hospital

    Dublin, 4835-044, Ireland

  • The 1st Hospital of Jilin Univ

    Changchun, 130031, China

  • The Cancer Institute Hospital of JFCR

    Kōtoku, 135-8550, Japan

  • The Chaim Sheba Medical Center

    Ramat Gan, 5265601, Israel

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

    Hong Kong, Hong Kong

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Liverpool, L9 7BA, United Kingdom

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450018, China

  • The Sixth Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong, 510655, China

  • Tolna M. Balassa Janos Korhaz

    Szekszárd, 7100, Hungary

  • Trakya Universitesi Balkan

    Edirne, 22030, Turkey (Türkiye)

  • UCL St. Luc

    Brussels, 1200, Belgium

  • UCLH Trust

    London, NW1 2PG, United Kingdom

  • UZ Leuven

    Leuven, 3000, Belgium

  • Uni zu Koln-Unikl. Koln

    Kln Nordrhein-westfalen, D-50937, Germany

  • Uniklinikum Carl-Gustav-Carus

    Dresden Sachsen, 1307, Germany

  • Universitares Krebszentrum

    Leipzig, 4103, Germany

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

    Birmingham, B15 2TH, United Kingdom

  • University of Oxford, The Churchill Hospital

    Oxford, OX3 7DQ, United Kingdom

  • Uniwersytecki Szpital Kliniczny im.Mikulicza-Radeckiego

    Wroclaw, 50-556, Poland

  • Velindre NHS Trust - Velindre Cancer Centre VCC

    Cardiff, CF14 2TL, United Kingdom

  • Xiamen University - The First Affiliated Hospital

    Xiamen, Fujian, 361003, China

  • Xinjiang Medical University - Cancer Hospital

    Ürümqi, Xinjiang, 830000, China

  • Zhejiang Medical University - Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China

  • Zhongnan univ Xiangya hosp

    Changshan, Hunan, 410008, China

  • Zhongshan Hosp Fudan Univ

    Shanghai, Shanghai Municipality, 200000, China

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