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

NCT04014075 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: DS8201-A-U2052019-001512-34
• Study Type: interventional
• Target: 79
• Locations: 5 countries
• Sites: 37

Brief 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 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.

Conditions

Adenocarcinoma Gastric Stage IV With Metastases; Adenocarcinoma - GEJ

Keywords

Human epidermal receptor 2 positive; Unresectable or metastatic; HER2; Prior treatment regimen included trastuzumab

Outcome Measures

Primary Outcomes (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.

  Up to 16 months (data cut-off)

• 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.

  Up to 23 months (data cut-off)

Secondary Outcomes (9)

• 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

  Up to 16 months (data cut-off)

• 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

  Up to 23 months (data cut-off)

• 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

  Up to 16 months (data cut-off)

• 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

  Up to 16 months (data cut-off)

• 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

  Up to 23 months (data cut-off)

Study Arms (1)

All participants

EXPERIMENTAL

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.

Drug: Trastuzumab deruxtecan

Interventions

Trastuzumab deruxtecan DRUG

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

Also known as: DS-8201a

All participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daiichi Sankyo: lead
• AstraZeneca: collaborator

Study Sites (37)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

USC Norris Comprehensive Cancer Center Hospital

Los Angeles, California, 90033, United States

Location

Pacific Cancer Care

Monterey, California, 93940, United States

Location

UCLA Health

Santa Monica, California, 90404, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

MidState Medical Center

Meriden, Connecticut, 06451, United States

Location

The Hospital of Central Connecticut

New Britain, Connecticut, 06052, United States

Location

Smilow Cancer Hospital at Yale-New Haven

New Haven, Connecticut, 06511, United States

Location

Miami Cancer Institute, Baptist Health South Florida

Miami, Florida, 33176, United States

Location

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

Chicago, Illinois, 60637, United States

Location

Kansas University Cancer Center

Kansas City, Kansas, 66205, United States

Location

Massachusetts General Hospital (MGH)

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center (BIDMC)

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Alvin J. Siteman Cancer Center Washington University

St Louis, Missouri, 63110, United States

Location

Northwell Health Cancer Institute

Lake Success, New York, 11042, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Washington/Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

UCL St-Luc

Brussels, 1200, Belgium

Location

Hopital de Jolimont

Haine-Saint-Paul, 7100, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

Location

Asst Grande Ospedale Metropolitano Niguarda

Milan, 20162, Italy

Location

Azienda Ospedaliero Universitaria di Modena Policlinico

Modena, 41124, Italy

Location

Oncology Institute Veneto IOVIRCCS

Padua, 35128, Italy

Location

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

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Institut Catalan de Oncologia Hospital Duran i Reynals

Barcelona, 8908, Spain

Location

Hospital la Paz

Madrid, 28046, Spain

Location

Hospital Universitario HM Sanchinarro

Madrid, 28050, Spain

Location

Biomedical Research Institute Hospital de Valencia

Valencia, 46010, Spain

Location

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0RE, United Kingdom

Location

The Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

Location

Christie Hospital

Manchester, M20 4BX, United Kingdom

Location

The Royal Marsden Hospital

Sutton, SM2 5PT, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 41294268 DERIVED

• 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.

  PMID: 37329891 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

trastuzumab deruxtecan

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Contact for Clinical Trial Information
• Organization: Daiichi Sankyo

CTRinfo@dsi.com

1-908-992-6400

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 10, 2019
• Study Start: November 26, 2019
• Primary Completion: November 8, 2021
• Study Completion: February 13, 2024
• Last Updated: April 3, 2025
• Results First Posted: January 12, 2022

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

ES (6); IT (4); GB (4); BE (3); US (20)