AzTrials
AzTrials

Gastric or Gastroesophageal Junction (GEJ) AdenocarcinomaPhase 2DG-06NCT04989816

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

A Phase 2 study testing Trastuzumab Deruxtecan in people with Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma, run by AstraZeneca at 24 sites in China.

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 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 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
95 participants
Where
24 sitesChina
Study dates
20 Aug 2021to 28 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

  • 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%

Who cannot join

  • 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.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

China24 sites

  • Research Site

    Beijing, 100142

  • Research Site

    Beijing, 100191

  • Research Site

    Changsha, 410008

  • Research Site

    Chengdu, 610042

  • Research Site

    Fuzhou, 350014

  • Research Site

    Guangzhou, 510062

  • Research Site

    Hangzhou, 310003

  • Research Site

    Hangzhou, 310009

  • Research Site

    Hangzhou, 310020

  • Research Site

    Hefei, 230001

  • Research Site

    Hefei, 230031

  • Research Site

    Jinan, 250001

  • Research Site

    Lanzhou, 730030

  • Research Site

    Nanchang, 330029

  • Research Site

    Nanchong, 637000

  • Research Site

    Nanjing, 210009

  • Research Site

    Shanghai, 200032

  • Research Site

    Shenyang, 110001

  • Research Site

    Suzhou, 215006

  • Research Site

    Wuhan, 430000

  • Research Site

    Xiamen, 361003

  • Research Site

    Yinchuan, 750004

  • Research Site

    Zhengzhou, 450000

  • Research Site

    Zhengzhou, 450008

Other trials in China

About this study

Official title: 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)

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

Being tested
Trastuzumab Deruxtecan
Keywords
Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, HER2, Trastuzumab, Deruxtecan, T-DXd, DS-8201a, ERBB2
Medical subject headings
Adenocarcinoma, Stomach Neoplasms

What participants receive

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

  • Trastuzumab DeruxtecanDrug

    Also called DS8201a; AZD4552; T-DXd

    Trastuzumab deruxtecan (T-DXd) by intravenous infusion

Study groups in NCT04989816
Study groupRoleWhat they receive
T-DXd armExperimentalT-DXd monotherapy
Receives: Drug: Trastuzumab Deruxtecan

What is being measured

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

  1. 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.

    Measured: 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

  2. 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

    Measured: 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)

  1. Progression-free Survival (PFS) Based on Independent Central Review (ICR)

    PFS based on ICR is defined as the time from date of enrolment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy prior to progression

    Measured: 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

  2. Progression-free Survival (PFS) Rate at 3 Months Based on Independent Central Review (ICR)

    PFS based on ICR is defined as the time from date of enrolment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy prior to progression

    Measured: 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

  3. Progression-free Survival (PFS) Rate at 6 Months Based on Independent Central Review (ICR)

    PFS based on ICR is defined as the time from date of enrolment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy prior to progression

    Measured: 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

  4. Progression-free Survival (PFS) Rate at 9 Months Based on Independent Central Review (ICR)

    PFS based on ICR is defined as the time from date of enrolment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy prior to progression

    Measured: 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

  5. Progression-free Survival (PFS) Rate at 12 Months Based on Independent Central Review (ICR)

    PFS based on ICR is defined as the time from date of enrolment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy prior to progression

    Measured: 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

  6. Progression-free Survival (PFS) Rate at 15 Months Based on Independent Central Review (ICR)

    PFS based on ICR is defined as the time from date of enrolment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy prior to progression

    Measured: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 15 months using the Kaplan-Meier technique

  7. Progression-free Survival (PFS) Rate at 18 Months Based on Independent Central Review (ICR)

    PFS based on ICR is defined as the time from date of enrolment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy prior to progression

    Measured: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 18 months using the Kaplan-Meier technique

  8. Progression-free Survival (PFS) Rate at 21 Months Based on Independent Central Review (ICR)

    PFS based on ICR is defined as the time from date of enrolment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy prior to progression

    Measured: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 21 months using the Kaplan-Meier technique

  9. Disease Control Rate (DCR) Based on Independent Central Review (ICR)

    Disease control rate based on ICR according to RECIST version 1.1 was defined as the rate of best objective response of complete response (CR), partial response (PR) or stable disease (SD)

    Measured: 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

  10. Disease Control Rate (DCR) Based on Independent Central Review (ICR) at Week 12

    Disease control rate based on ICR according to RECIST version 1.1 was defined as the rate of best objective response of complete response (CR), partial response (PR) or stable disease (SD) for at least 11 weeks (ie 12 weeks - 1 week to allow for an early assessment within the assessment window)

    Measured: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. DCR assessed at Week 12

  11. Duration of Response (DoR) Based on Independent Central Review (ICR)

    DoR defined as the time from the date of first documented OR (confirmed CR or confirmed PR) until date of documented progression (PD) or death in the absence of progression based on investigator assessments by using RECIST version 1.1

    Measured: 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

  12. Overall Survival (OS) Based on Independent Central Review (ICR)

    OS based on ICR is defined as the time from date of enrolment until the date of death due to any cause

    Measured: From date of enrolment until death due to any cause. Assessed up to approximately 30 months (from date of first subject in to data cut-off 28February2024)

  13. Best Percentage Change in Sum of Diameters of Measurable Tumours Based on Independent Central Review (ICR)

    Best percentage change based on ICR is defined as the best change in target lesion tumour size from baseline (maximum reduction or minimum increase from baseline in the absence of a reduction)

    Measured: 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

Timeline

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

  1. First posted4 Aug 2021
  2. Study start20 Aug 2021
  3. Primary completion16 Jun 2023
  4. Study completion28 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
Model description
Single group assignment
Masking
None (open label)
Enrolment
95 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04989816
Sponsor's protocol ID
D9676C00002
Acronym
DG-06
Status last verified
Nov 2024
First submitted
14 Jul 2021
Last updated
21 Nov 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trastuzumab Deruxtecan in people with Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma, run by AstraZeneca at 24 sites in China.

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 6 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 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in China. 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 21 Nov 2024). 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?

Confirmed Objective Response Rate by RECIST 1.1 Based on Independent Central Review (ICR) (time frame: 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). 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 NCT04989816.

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 21 Nov 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in