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Adenocarcinoma Gastric Stage IV With MetastasesPhase 2NCT04014075

DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02)

A Phase 2 study testing Trastuzumab deruxtecan in people with Adenocarcinoma Gastric Stage IV With Metastases and Adenocarcinoma - GEJ, run by Daiichi Sankyo at 37 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will find out if trastuzumab deruxtecan is safe and works for participants with gastric or gastroesophageal junction cancer. 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Trastuzumab deruxtecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
37 sitesin 5 countries
Study dates
26 Nov 2019to 13 Feb 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Men or women ≥18 years old (local regulatory guidelines apply)
  • 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

Who cannot join

  • Has had anticancer therapy after first-line treatment regimen containing trastuzumab
  • 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.

Trial locations and contacts

37 sites in 5 countries.

37 sites in 5 countries

United States20 sites

  • Lehigh Valley Health Network

    Allentown, Pennsylvania, 18103

  • Massachusetts General Hospital (MGH)

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center (BIDMC)

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • University of Chicago Medical Center UCMC Duchossois Center for Advanced Medicine DCAM

    Chicago, Illinois, 60637

  • City of Hope Medical Center

    Duarte, California, 91010

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Kansas University Cancer Center

    Kansas City, Kansas, 66205

  • Northwell Health Cancer Institute

    Lake Success, New York, 11042

  • USC Norris Comprehensive Cancer Center Hospital

    Los Angeles, California, 90033

  • MidState Medical Center

    Meriden, Connecticut, 06451

  • Miami Cancer Institute, Baptist Health South Florida

    Miami, Florida, 33176

  • Pacific Cancer Care

    Monterey, California, 93940

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06052

  • Smilow Cancer Hospital at Yale-New Haven

    New Haven, Connecticut, 06511

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • UCLA Health

    Santa Monica, California, 90404

  • University of Washington/Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Alvin J. Siteman Cancer Center Washington University

    St Louis, Missouri, 63110

Other trials in United States

Spain6 sites

  • Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO)

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Institut Catalan de Oncologia Hospital Duran i Reynals

    Barcelona, 8908

  • Hospital la Paz

    Madrid, 28046

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050

  • Biomedical Research Institute Hospital de Valencia

    Valencia, 46010

Other trials in Spain

Italy4 sites

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • Asst Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • Azienda Ospedaliero Universitaria di Modena Policlinico

    Modena, 41124

  • Oncology Institute Veneto IOVIRCCS

    Padua, 35128

Other trials in Italy

United Kingdom4 sites

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0RE

  • The Royal Marsden Hospital

    London, SW3 6JJ

  • Christie Hospital

    Manchester, M20 4BX

  • The Royal Marsden Hospital

    Sutton, SM2 5PT

Other trials in United Kingdom

Belgium3 sites

  • UCL St-Luc

    Brussels, 1200

  • Hopital de Jolimont

    Haine-Saint-Paul, 7100

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

About this study

Official title: A Phase 2, Open-label, Single-arm Trial of Trastuzumab Deruxtecan (DS 8201a) in HER2-positive, Unresectable or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma Subjects Who Have Progressed on or After a Trastuzumab-containing Regimen (DESTINY-Gastric02)

This study will find out if trastuzumab deruxtecan is safe and works for participants with gastric or gastroesophageal junction cancer.

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.

Being tested
Trastuzumab deruxtecan
Keywords
Human epidermal receptor 2 positive, Unresectable or metastatic, HER2, Prior treatment regimen included trastuzumab
Medical subject headings
Neoplasm Metastasis

What participants receive

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

  • Trastuzumab deruxtecanDrug

    Also called DS-8201a

    Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion

Study groups in NCT04014075
Study groupRoleWhat they receive
All participantsExperimentalParticipants 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.
Receives: Drug: Trastuzumab deruxtecan

What is being measured

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

  1. Percentage of Participants With Objective Response Rate (ORR) Based on Independent Central Review Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma

    The Objective Response Rate (ORR) was the defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by independent central review (ICR) committee based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on ICR is reported.

    Measured: Up to 16 months (data cut-off)

  2. Percentage of Participants With Objective Response Rate (ORR) Based on Independent Central Review Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma

    The Objective Response Rate (ORR) was the defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by independent central review (ICR) committee based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on ICR is reported.

    Measured: Up to 23 months (data cut-off)

Secondary outcomes (9)

  1. Progression-Free Survival (PFS) Based on Independent Central Review Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma

    Progression-free survival (PFS) by independent central review was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.

    Measured: Up to 16 months (data cut-off)

  2. Progression-Free Survival (PFS) Based on Independent Central Review Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma

    Progression-free survival (PFS) by independent central review was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.

    Measured: Up to 23 months (data cut-off)

  3. Progression-Free Survival (PFS) Based on Investigator Assessment Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma

    Progression-free survival (PFS) by investigator assessment was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.

    Measured: Up to 16 months (data cut-off)

  4. Objective Response Rate (ORR) Based on Investigator Assessment Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma

    The Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigator assessment based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on investigator assessment is reported.

    Measured: Up to 16 months (data cut-off)

  5. Objective Response Rate (ORR) Based on Investigator Assessment Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma

    The Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigator assessment based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on investigator assessment is reported.

    Measured: Up to 23 months (data cut-off)

  6. Overall Survival (OS) Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma

    Overall survival (OS) was defined as the time from the date of first dose of study drug to the date of death due to any cause.

    Measured: Up to 16 months (data cut-off)

  7. Overall Survival (OS) Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma

    Overall survival (OS) was defined as the time from the date of first dose of study drug to the date of death due to any cause.

    Measured: Up to 23 months (data cut-off)

  8. Duration of Response (DoR) Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma

    Duration of Response (DOR) was defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR based on independent central review.

    Measured: Up to 16 months (data cut-off)

  9. Duration of Response (DoR) Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma

    Duration of Response (DOR) was defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR based on independent central review.

    Measured: Up to 23 months (data cut-off)

Timeline

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

  1. First posted10 Jul 2019
  2. Study start26 Nov 2019
  3. Primary completion8 Nov 2021
  4. Study completion13 Feb 2024

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04014075
Sponsor's protocol ID
DS8201-A-U205
Other IDs
2019-001512-34, 2019
Status last verified
Mar 2025
First submitted
8 Jul 2019
Last updated
3 Apr 2025
Data monitoring committee
No
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

  • Kapil A, Failmezger H, Fu Y, Spitzmuller A, Chan J, Haneder S, Shumilov A, Barkell A, Oguma T, Inaki K, Suto F, Allard J, Lee J, Lambert AW, Schick M, Barrett JC, Schmidt G, Sade H, Gustavson M, Carroll D, Cecchi F. Human Epidermal Growth Factor Receptor 2 Quantification Using Computational Pathology to Identify Novel Biomarkers for Trastuzumab Deruxtecan-Treated Human Epidermal Growth Factor Receptor 2-Positive Gastric Cancer. JCO Precis Oncol. 2026 May;10(5):e2500823. doi: 10.1200/PO-25-00823. Epub 2026 May 28.

    PubMed 42208007

  • Van Cutsem E. Trastuzumab deruxtecan in HER2-positive stomach or gastroesophageal junction cancer: a plain language summary of the DESTINY-Gastric02 study. Future Oncol. 2025 Dec;21(29):3691-3700. doi: 10.1080/14796694.2025.2567230. Epub 2025 Nov 26.

    PubMed 41294268

  • 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.

    PubMed 37329891

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trastuzumab deruxtecan in people with Adenocarcinoma Gastric Stage IV With Metastases and Adenocarcinoma - GEJ, run by Daiichi Sankyo at 37 sites in 5 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, Spain, Italy, United Kingdom, Belgium. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Objective Response Rate (ORR) Based on Independent Central Review Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma (time frame: Up to 16 months (data cut-off)). The study lists 2 primary outcomes in all. 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 NCT04014075, which also lists 3 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 3 Apr 2025.

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