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 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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04989816

Acronym

DG-06

Enrollment

Registered

2021-08-04

Start date

2021-08-20

Completion date

2024-02-28

Last updated

2024-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Keywords

Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, HER2, Trastuzumab, Deruxtecan, T-DXd, DS-8201a, ERBB2

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

Interventions

DRUGTrastuzumab Deruxtecan

Trastuzumab deruxtecan (T-DXd) by intravenous infusion

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Single group assignment

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Male or female ≥ 18 years of age 2. Pathologically documented gastric or GEJ adenocarcinoma 3. Disease progression on or after ≥ 2 prior platinum and fluoropyrimidine agents for advanced/metastatic disease 4. ECOG PS 0-1 5. Willing and able to provide an adequate newly-acquired tumour sample for confirmation of HER2 status 6. LVEF ≥ 50%

Exclusion criteria

1. Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and CART. Drainage and CART. 2. Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids 3. Active primary immunodeficiency, known HIV, active HBV, HCV infection. 4. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals. 5. History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening. 6. Lung-specific intercurrent clinically significant severe illnesses.

Design outcomes

Primary

Measure	Time frame	Description
Confirmed Objective Response Rate by RECIST 1.1 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 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.
Best Objective Response Rate by RECIST 1.1 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 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

Measure	Time frame	Description
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	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
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	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
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	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
Progression-free Survival (PFS) Rate at 15 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 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
Progression-free Survival (PFS) Rate at 18 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 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
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	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
Disease Control Rate (DCR) 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	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)
Disease Control Rate (DCR) Based on Independent Central Review (ICR) at Week 12	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)
Duration of Response (DoR) 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	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
Overall Survival (OS) Based on Independent Central Review (ICR)	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
Best Percentage Change in Sum of Diameters of Measurable Tumours 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	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)
Progression-free Survival (PFS) Rate at 21 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 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
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	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

Countries

China

Participant flow

Participants by arm

Arm	Count
T-DXd Arm T-DXd monotherapy	95
Total	95

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Death	77
Overall Study	Lost to Follow-up	3

Baseline characteristics

Characteristic	T-DXd Arm
Age, Continuous	60 Years
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	95 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	95 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	0 Participants
Sex: Female, Male Female	22 Participants
Sex: Female, Male Male	73 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	77 / 95
other Total, other adverse events	93 / 95
serious Total, serious adverse events	40 / 95

Outcome results

Primary

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

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