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
DG-06
A Single-arm Study of Trastuzumab Deruxtecan (T-DXd) Monotherapy for Patients With HER2-expressing Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Who Have Received 2 or More Prior Regimens (DESTINY-Gastric06)
1 other identifier
interventional
95
1 country
24
Brief Summary
This is a Phase II, open-label, single-arm, multicentre, study in China assessing the efficacy and safety of T-DXd in participants with HER2-expressing advanced gastric or GEJ adenocarcinoma who have received at least 2 prior regimens including a fluoropyrimidine agent and a platinum agent
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2021
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2021
CompletedFirst Posted
Study publicly available on registry
August 4, 2021
CompletedStudy Start
First participant enrolled
August 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2024
CompletedResults Posted
Study results publicly available
November 21, 2024
CompletedNovember 21, 2024
November 1, 2024
1.8 years
July 14, 2021
June 14, 2024
November 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Confirmed Objective Response Rate by RECIST 1.1 Based on Independent Central Review (ICR)
Confirmed ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by ICR per RECIST 1.1.
Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Assessed up to a maximum of 19.3 months
Best Objective Response Rate by RECIST 1.1 Based on Independent Central Review (ICR)
The best response based on the overall visit responses from each RECIST 1.1 assessment or the last evaluable assessment in the absence of RECIST 1.1 progression
Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Assessed up to a maximum of 19.3 months
Secondary Outcomes (13)
Progression-free Survival (PFS) Based on Independent Central Review (ICR)
Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Assessed up to a maximum of 22 months
Progression-free Survival (PFS) Rate at 3 Months Based on Independent Central Review (ICR)
Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 3 months using the Kaplan-Meier technique
Progression-free Survival (PFS) Rate at 6 Months Based on Independent Central Review (ICR)
Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 6 months using the Kaplan-Meier technique
Progression-free Survival (PFS) Rate at 9 Months Based on Independent Central Review (ICR)
Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 9 months using the Kaplan-Meier technique
Progression-free Survival (PFS) Rate at 12 Months Based on Independent Central Review (ICR)
Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 12 months using the Kaplan-Meier technique
- +8 more secondary outcomes
Study Arms (1)
T-DXd arm
EXPERIMENTALT-DXd monotherapy
Interventions
Trastuzumab deruxtecan (T-DXd) by intravenous infusion
Eligibility Criteria
You may qualify if:
- Male or female ≥ 18 years of age
- Pathologically documented gastric or GEJ adenocarcinoma
- Disease progression on or after ≥ 2 prior platinum and fluoropyrimidine agents for advanced/metastatic disease
- ECOG PS 0-1
- Willing and able to provide an adequate newly-acquired tumour sample for confirmation of HER2 status
- LVEF ≥ 50%
You may not qualify if:
- Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and CART. Drainage and CART.
- Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids
- Active primary immunodeficiency, known HIV, active HBV, HCV infection.
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
- History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening.
- Lung-specific intercurrent clinically significant severe illnesses.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Daiichi Sankyo Co., Ltd.collaborator
Study Sites (24)
Research Site
Beijing, 100142, China
Research Site
Beijing, 100191, China
Research Site
Changsha, 410008, China
Research Site
Chengdu, 610042, China
Research Site
Fuzhou, 350014, China
Research Site
Guangzhou, 510062, China
Research Site
Hangzhou, 310003, China
Research Site
Hangzhou, 310009, China
Research Site
Hangzhou, 310020, China
Research Site
Hefei, 230001, China
Research Site
Hefei, 230031, China
Research Site
Jinan, 250001, China
Research Site
Lanzhou, 730030, China
Research Site
Nanchang, 330029, China
Research Site
Nanchong, 637000, China
Research Site
Nanjing, 210009, China
Research Site
Shanghai, 200032, China
Research Site
Shenyang, 110001, China
Research Site
Suzhou, 215006, China
Research Site
Wuhan, 430000, China
Research Site
Xiamen, 361003, China
Research Site
Yinchuan, 750004, China
Research Site
Zhengzhou, 450000, China
Research Site
Zhengzhou, 450008, China
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca Clinical Study Information Center
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 14, 2021
First Posted
August 4, 2021
Study Start
August 20, 2021
Primary Completion
June 16, 2023
Study Completion
February 28, 2024
Last Updated
November 21, 2024
Results First Posted
November 21, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . A Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.