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Completed

NCT Number: NCT04989816

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

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

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Key information

Conditions

Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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%

Exclusion criteria

  • 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.

Treatment and study plan

Trastuzumab Deruxtecan

Drug

Trastuzumab deruxtecan (T-DXd) by intravenous infusion

Other names: DS8201a; AZD4552; T-DXd

Primary outcomes

  1. 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

    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.

  2. Best 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 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

Secondary outcomes

  1. Progression-free Survival (PFS) 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 22 months

    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

  2. Progression-free Survival (PFS) Rate at 3 Months 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. Calculated at 3 months using the Kaplan-Meier technique

    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

  3. Progression-free Survival (PFS) Rate at 6 Months 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. Calculated at 6 months using the Kaplan-Meier technique

    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

  4. Progression-free Survival (PFS) Rate at 9 Months 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. Calculated at 9 months using the Kaplan-Meier technique

    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

  5. Progression-free Survival (PFS) Rate at 12 Months 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. Calculated at 12 months using the Kaplan-Meier technique

    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

  6. Progression-free Survival (PFS) Rate at 15 Months 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. Calculated at 15 months using the Kaplan-Meier technique

    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

  7. Progression-free Survival (PFS) Rate at 18 Months 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. Calculated at 18 months using the Kaplan-Meier technique

    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

  8. Progression-free Survival (PFS) Rate at 21 Months 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. Calculated at 21 months using the Kaplan-Meier technique

    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

  9. Disease Control Rate (DCR) 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 22 months

    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)

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

    Time frame: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. DCR assessed 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)

  11. Duration of Response (DoR) 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 22 months

    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

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

    Time frame: 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)

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

  13. Best Percentage Change in Sum of Diameters of Measurable Tumours 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 22 months

    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)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Daiichi Sankyo Co., Ltd.

Registry information

Official study 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)

Acronym: DG-06

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Aug 4, 2021
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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