DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02)
NCT ID: NCT04014075
Last Updated: 2025-04-03
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
79 participants
INTERVENTIONAL
2019-11-26
2024-02-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
They must have human epidermal growth factor receptor 2 (HER2)-positive gastric or gastro-esophageal junction (GEJ) cancer:
* that cannot be removed surgically
* that has moved to other parts of the body
* that got worse during or after treatment that included trastuzumab
The study will enroll about 80 participants. Sites will be in North America and the European Union.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
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)
NCT04704934
DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01]
NCT03329690
Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)
NCT04379596
Trastuzumab Plus Docetaxel and Capecitabine For First Line Treatment of Her2-Positive Advanced Gastric Cancer
NCT02004769
Study of T-DXd Monotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Gastric or GEJ Adenocarcinoma Who Have Received 2 or More Prior Regimens
NCT04989816
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
All participants
Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer will be treated with trastuzumab deruxtecan by intravenous (IV) infusion every 3 weeks, until progression of disease or withdrawal from treatment for other reasons.
Trastuzumab deruxtecan
Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Trastuzumab deruxtecan
Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Has pathologically documented HER2-positive gastric or GEJ cancer that is unresectable or metastatic, and that progressed during or after treatment regimen containing trastuzumab
* Has at least one measurable lesion per RECIST v1.1, as confirmed by investigator review
* If of reproductive potential, agrees to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7 months for females and 4 months for males after the last dose of study drug
Exclusion Criteria
* Has uncontrolled cardiovascular disease, including any of the following: history of myocardial infarction (MI) within 6 months of first dose or symptomatic congestive heart failure (New York Heart Association Class II to IV), troponin levels consistent with MI as defined according to the manufacturer within 28 days of first dose, or corrected QT interval (QTc) prolongation to \>470 ms (females) or \>450 ms (male) based on screening triplicate 12-lead electrocardiogram (ECG)
* Has history of non-infectious interstitial lung disease (ILD)/pneumonitis that required corticosteroid therapy, or current ILD/pneumonitis that cannot be ruled out at screening
* Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the first dose, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion, etc.), and any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren's, sarcoidosis, etc.), or prior pneumonectomy.
* Has pleural effusion, ascites, or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART)
* Has 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 (Note: participants with clinically inactive brain metastases may be included in the study as well as participants with treated brain metastases who are no longer symptomatic and no longer require treatment with corticosteroids or anticonvulsants.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Daiichi Sankyo
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Global Clinical Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
City of Hope Medical Center
Duarte, California, United States
USC Norris Comprehensive Cancer Center Hospital
Los Angeles, California, United States
Pacific Cancer Care
Monterey, California, United States
UCLA Health
Santa Monica, California, United States
Hartford Hospital
Hartford, Connecticut, United States
MidState Medical Center
Meriden, Connecticut, United States
The Hospital of Central Connecticut
New Britain, Connecticut, United States
Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, United States
Miami Cancer Institute, Baptist Health South Florida
Miami, Florida, United States
University of Chicago Medical Center UCMC Duchossois Center for Advanced Medicine DCAM
Chicago, Illinois, United States
Kansas University Cancer Center
Kansas City, Kansas, United States
Massachusetts General Hospital (MGH)
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Alvin J. Siteman Cancer Center Washington University
St Louis, Missouri, United States
Northwell Health Cancer Institute
Lake Success, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Washington/Seattle Cancer Care Alliance
Seattle, Washington, United States
UCL St-Luc
Brussels, , Belgium
Hopital de Jolimont
Haine-Saint-Paul, , Belgium
UZ Leuven
Leuven, , Belgium
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Asst Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Azienda Ospedaliero Universitaria di Modena Policlinico
Modena, , Italy
Oncology Institute Veneto IOVIRCCS
Padua, , Italy
Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO)
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Institut Catalan de Oncologia Hospital Duran i Reynals
Barcelona, , Spain
Hospital la Paz
Madrid, , Spain
Hospital Universitario HM Sanchinarro
Madrid, , Spain
Biomedical Research Institute Hospital de Valencia
Valencia, , Spain
Cambridge University Hospitals NHS Foundation Trust
Cambridge, , United Kingdom
The Royal Marsden Hospital
London, , United Kingdom
Christie Hospital
Manchester, , United Kingdom
The Royal Marsden Hospital
Sutton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Van Cutsem E, di Bartolomeo M, Smyth E, Chau I, Park H, Siena S, Lonardi S, Wainberg ZA, Ajani J, Chao J, Janjigian Y, Qin A, Singh J, Barlaskar F, Kawaguchi Y, Ku G. Trastuzumab deruxtecan in patients in the USA and Europe with HER2-positive advanced gastric or gastroesophageal junction cancer with disease progression on or after a trastuzumab-containing regimen (DESTINY-Gastric02): primary and updated analyses from a single-arm, phase 2 study. Lancet Oncol. 2023 Jul;24(7):744-756. doi: 10.1016/S1470-2045(23)00215-2. Epub 2023 Jun 14.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-001512-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DS8201-A-U205
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.