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NCT04704934

PHASE3

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)

Sponsor: Daiichi Sankyo

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

490

Start Date

2021-05-21

Completion Date

2026-08-31

Last Updated

2026-05-27

Healthy Volunteers

Conditions

Gastric Cancer, Adenocarcinoma Gastroesophageal Junction Adenocarcinoma

Interventions

DRUG

Trastuzumab deruxtecan

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

DRUG

Ramucirumab

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

DRUG

Paclitaxel

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

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

Locations (156)

Instituto Medico Especializado Alexander Fleming

Colegiales, Buenos Aires F.D., Argentina

IONC Instituto Oncologico de Cordoba - Fundacion Richardet Longo

Nueva Cordoba, Córdoba Province, Argentina

Exelsus

San Miguel de Tucumán, Tucumán Province, Argentina

Fundacion Cenit

Buenos Aires, Argentina

UCL St. Luc

Brussels, Belgium

Antwerp University Hospital

Edegem, Belgium

Pôle Hospitalier Jolimont

Haine-Saint-Paul, Belgium

UZ Leuven

Leuven, Belgium

PERSONAL - Oncologia de Precisao e Personalizada

Belo Horizonte, Brazil

Hospital Sirio Libanes

Brasília, Brazil

ONCOSITE - Centro de Pesquisa Clinica em Oncologia LTDA

Ijuí, Brazil

Hospital Ernesto Dornelles

Porto Alegre, Brazil

SIM Centro de Investigacion Clinica

Temuco, Cautin, Chile

Fundacion Arturo Lopez Perez

Santiago, Santiago Metropolitan, Chile

Clinica San Carlos de Apoquindo

Santiago, Santiago Metropolitan, Chile

Anhui Provincial Hospital

Heifi, Anhui, China

Fujian Medical University - Fujian Provincial Cancer Hospital

Fuzhou, Fuijan, China

Xiamen University - The First Affiliated Hospital

Xiamen, Fujian, China

The Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

1Affiliated H of Sun Yat Sen U

Guangzhou, Guangdong, China

Hebei Medical Univ 4th Hosp

Shijiazhuang, Hebei, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Zhongnan univ Xiangya hosp

Changshan, Hunan, China

Jiangsu Province Hosp

Nanjing, Jiangsu, China

Liaoning Cancer Hospital

Shenyang, Liaoning, China

1st Hosp of China Medical Univ

Shenyang, Liaoning, China

Shandong Cancer Hospital & Institute

Jinan, Shandong, China

Zhongshan Hosp Fudan Univ

Shanghai, Shanghai Municipality, China

Shanghai First People's Hosp

Shanghai, Shanghai Municipality, China

Xinjiang Medical University - Cancer Hospital

Ürümqi, Xinjiang, China

Zhejiang Medical University - Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Beijing Cancer Hospital

Beijing, China

Peking Univ 3rd Hosp

Beijing, China

The 1st Hospital of Jilin Univ

Changchun, China

Sir Run Run Shaw Hospital

Hangzhou, China

Linyi Cancer Hospital

Linyi, China

1 Affiliated H of Nanchang U

Nanchang, China

Fudan University - Shanghai Cancer Center

Shanghai, China

CHU Besançon

Besançon, France

CHRU

Brest, France

Centre Oscar Lambret

Lille, France

Centre Leon Berard

Lyon, France

Hopital de la Timone

Marseille, France

Institut de Recherche en Cancerologie de Montpellier IRCM

Montpellier, France

Hopital Saint Antoine

Paris, France

L Institut Mutualiste Montsouris

Paris, France

Hopital Europeen G. Pompidou

Paris, France

Pharmacie ICLN

Saint-Priest-en-Jarez, France

Gustave Roussy, étage -1.

Villejuif, France

Charité-Unimedizin Berlin

Berlin, Germany

Uniklinikum Carl-Gustav-Carus

Dresden Sachsen, Germany

Evang. Klin. Essen-Mitte gGmbH

Essen, Germany

Ins. für klinische onk. Forschung

Frankfurt Am Main Hessen, Germany

Häm-Onk. Praxis Eppendorf

Hamburg, Germany

Asklepios Tumorzentrum Altona

Hamburg, Germany

Uni zu Koln-Unikl. Koln

Kln Nordrhein-westfalen, Germany

Universitares Krebszentrum

Leipzig, Germany

Pamela Youde Nethersole Eastern Hospital

Chai Wan, Hong Kong

Princess Margaret Hospital

Hong Kong, Hong Kong

Queen Mary 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

Hong Kong, Hong Kong

Magyar Honvedseg Egeszs. K

Budapest, Hungary

Debreceni Egyetem Klinikai

Debrecen, Hungary

Tolna M. Balassa Janos Korhaz

Szekszárd, Hungary

Cork University Hospital

Cork, Ireland

Tallaght University Hospital

Dublin, Ireland

Beaumont Hospital

Dublin, Ireland

St James's Hospital

Dublin, Ireland

Soroka Univ Medical CTR

Be'er-Sheva Southern, Israel

Davidoff Center

Petah Tikva, Israel

The Chaim Sheba Medical Center

Ramat Gan, Israel

AOU Pisana

Barone, Italy

IRCC-FPO Candiolo

Candiolo, Italy

AOU Mater Domini

Catanzaro, Italy

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

Milan, Italy

Ospedale Niguarda

Milan, Italy

San Raffaele Hospital

Milan, Italy

Istituto Nazionale dei Tumori

Milan, Italy

Azienda Ospedaliero-Universitaria di Modena

Modena, Italy

Aou Vanvitelli

Naples, Italy

Istituto Oncologico Veneto

Padua, Italy

Azienda Ospedaliero-Universitaria Pisana

Pisa, Italy

Aichi Cancer Center Hospital

Nagoya, Aichia, Japan

National Cancer Center Hospital

Chūōku, Japan

Osaka International Cancer Institute

Chūōku, Japan

Gifu University Hospital

Gifu, Japan

National Cancer Center Hospital East

Kashiwa, Japan

Kobe City Medical Center General Hospital

Kobe, Japan

Kochi Health Sciences Center

Kochi, Japan

The Cancer Institute Hospital of JFCR

Kōtoku, Japan

National Hospital Organization Shikoku Cancer Center

Matsuyama, Japan

Niigata Cancer Center Hospital

Niigata, Japan

Kindai University Hospital

Ōsaka-sayama, Japan

Osaka University Hospital

Suita, Japan

Sklodowska-Curie Inst Oncology

Warsaw, Poland

Uniwersytecki Szpital Kliniczny im.Mikulicza-Radeckiego

Wroclaw, Poland

Hospital Sra da Oliveira

Creixomil E Mariz, Portugal

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

Porto, Portugal

C Hosp Tras Montes Alto Douro

Vila Real, Portugal

And 56 more locations on ClinicalTrials.gov

Clinical Research Directory

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)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (156)