Clinical trial 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
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Keywords: Gastric Cancer
Gastroesophageal Junction Adenocarcinoma
HER2
Trastuzumab
Deruxtecan
T-DXd
DS-8201a
ERBB2
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Daiichi Sankyo Co., Ltd.
First posted: 2021-08-04
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group assignment
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Confirmed Objective Response Rate by RECIST 1.1 Based on Independent Central Review (ICR)
timeFrame: 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
measure: Best Objective Response Rate by RECIST 1.1 Based on Independent Central Review (ICR)
timeFrame: 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:
measure: Progression-free Survival (PFS) Based on Independent Central Review (ICR)
timeFrame: 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
measure: Progression-free Survival (PFS) Rate at 3 Months Based on Independent Central Review (ICR)
timeFrame: 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
measure: Progression-free Survival (PFS) Rate at 6 Months Based on Independent Central Review (ICR)
timeFrame: 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
measure: Progression-free Survival (PFS) Rate at 9 Months Based on Independent Central Review (ICR)
timeFrame: 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
measure: Progression-free Survival (PFS) Rate at 12 Months Based on Independent Central Review (ICR)
timeFrame: 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
measure: Progression-free Survival (PFS) Rate at 15 Months Based on Independent Central Review (ICR)
timeFrame: 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
measure: Progression-free Survival (PFS) Rate at 18 Months Based on Independent Central Review (ICR)
timeFrame: 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
measure: Progression-free Survival (PFS) Rate at 21 Months Based on Independent Central Review (ICR)
timeFrame: 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
measure: Disease Control Rate (DCR) Based on Independent Central Review (ICR)
timeFrame: 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
measure: Disease Control Rate (DCR) Based on Independent Central Review (ICR) at Week 12
timeFrame: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. DCR assessed at Week 12
measure: Duration of Response (DoR) Based on Independent Central Review (ICR)
timeFrame: 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
measure: Overall Survival (OS) Based on Independent Central Review (ICR)
timeFrame: 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)
measure: Best Percentage Change in Sum of Diameters of Measurable Tumours Based on Independent Central Review (ICR)
timeFrame: 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
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Changsha
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Fuzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Hefei
country: China
facility: Research Site
city: Hefei
country: China
facility: Research Site
city: Jinan
country: China
facility: Research Site
city: Lanzhou
country: China
facility: Research Site
city: Nan Chong
country: China
facility: Research Site
city: Nanchang
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shenyang
country: China
facility: Research Site
city: Suzhou
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Xiamen
country: China
facility: Research Site
city: Yinchuan
country: China
facility: Research Site
city: Zhengzhou City
country: China
facility: Research Site
city: Zhengzhou
country: China
facility: Research Site
Study officials:
References: