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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
Phase 2 trial testing Trastuzumab Deruxtecan in Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma in 95 participants. Completed in 28 February 2024.
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 95 |
| Start date | 20 August 2021 |
| Primary completion | 16 June 2023 |
| Estimated completion | 28 February 2024 |
| Sites | 24 locations across China |
AstraZeneca — full company profile →
18 and older, any sex, with Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| T-DXd Arm | 28.8 | 18.8 – 40.6 |
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
| Group | Value | 95% CI |
|---|---|---|
| T-DXd Arm | 1 |
| Group | Value | 95% CI |
|---|---|---|
| T-DXd Arm | 20 |
| Group | Value | 95% CI |
|---|---|---|
| T-DXd Arm | 37 |
| Group | Value | 95% CI |
|---|---|---|
| T-DXd Arm | 14 |
| Group | Value | 95% CI |
|---|---|---|
| T-DXd Arm | 1 |
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
| Group | Value | 95% CI |
|---|---|---|
| T-DXd Arm | 5.7 | 4.0 – 6.8 |
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
| Group | Value | 95% CI |
|---|---|---|
| T-DXd Arm | 69.0 | 56.8 – 78.4 |
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
| Group | Value | 95% CI |
|---|---|---|
| T-DXd Arm | 43.4 | 30.8 – 55.3 |
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
| Group | Value | 95% CI |
|---|---|---|
| T-DXd Arm | 27.1 | 16.2 – 39.3 |
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
| Group | Value | 95% CI |
|---|---|---|
| T-DXd Arm | 16.7 | 8.0 – 28.1 |
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
| Group | Value | 95% CI |
|---|---|---|
| T-DXd Arm | 11.9 | 4.7 – 22.8 |
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
| Group | Value | 95% CI |
|---|---|---|
| T-DXd Arm | 4.0 | 0.4 – 15.6 |
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
| Group | Value | 95% CI |
|---|---|---|
| T-DXd Arm | 4.0 | 0.4 – 15.6 |
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)
| Group | Value | 95% CI |
|---|---|---|
| T-DXd Arm | 79.5 | 68.4 – 88.0 |
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)
| Group | Value | 95% CI |
|---|---|---|
| T-DXd Arm | 74.0 | 62.4 – 83.5 |
Time frame: From the signature of the informed consent form until 40 (+7) days after the last dose of study treatment or until the start of the first subsequent anticancer therapy after discontinuation of study treatment, whichever comes first (maximum treatment duration of 19.3 months). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | T-DXd |
|---|---|---|
| Platelet count decreased | Investigations | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Covid-19 | Infections and infestations | — |
| Pneumonia | Infections and infestations | — |
| Asthenia | General disorders | — |
| Covid-19 pneumonia | Infections and infestations | — |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | — |
| Hepatic function abnormal | Hepatobiliary disorders | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — |
| Death | General disorders | — |
| Hypoalbuminaemia | Metabolism and nutrition disorders | — |
| Hypokalaemia | Metabolism and nutrition disorders | — |
| Dysphagia | Gastrointestinal disorders | — |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Jaundice cholestatic | Hepatobiliary disorders | — |
| Gastrointestinal infection | Infections and infestations | — |
| Myelosuppression | Blood and lymphatic system disorders | — |
| White blood cell count decreased | Investigations | — |
| Malnutrition | Metabolism and nutrition disorders | — |
| Cerebral infarction | Nervous system disorders | — |
| Arrhythmia | Cardiac disorders | — |
| Mental disorder | Psychiatric disorders | — |
| Abdominal distension | Gastrointestinal disorders | — |
| Reaction | System | T-DXd |
|---|---|---|
| Anaemia | Blood and lymphatic system disorders | — |
| White blood cell count decreased | Investigations | — |
| Neutrophil count decreased | Investigations | — |
| Platelet count decreased | Investigations | — |
| Nausea | Gastrointestinal disorders | — |
| Decreased appetite | Metabolism and nutrition disorders | — |
| Hypoalbuminaemia | Metabolism and nutrition disorders | — |
| Aspartate aminotransferase increased | Investigations | — |
| Vomiting | Gastrointestinal disorders | — |
| Weight decreased | Investigations | — |
| Hypokalaemia | Metabolism and nutrition disorders | — |
| Asthenia | General disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Hypocalcaemia | Metabolism and nutrition disorders | — |
| Hyponatraemia | Metabolism and nutrition disorders | — |
| Fatigue | General disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Lymphocyte count decreased | Investigations | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Covid-19 | Infections and infestations | — |
| Blood alkaline phosphatase increased | Investigations | — |
| Blood bilirubin increased | Investigations | — |
| Gamma-glutamyltransferase increased | Investigations | — |
| Hyperuricaemia | Metabolism and nutrition disorders | — |
| Dizziness | Nervous system disorders | — |
| Pyrexia | General disorders | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — |
| Abdominal distension | Gastrointestinal disorders | — |
| Oedema peripheral | General disorders | — |
| Insomnia | Psychiatric disorders | — |
| Bilirubin conjugated increased | Investigations | — |
| Blood creatinine increased | Investigations | — |
| White blood cell count increased | Investigations | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — |
| Hypochloraemia | Metabolism and nutrition disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Dyspepsia | Gastrointestinal disorders | — |
| Hypoaesthesia | Nervous system disorders | — |
| Hepatic function abnormal | Hepatobiliary disorders | — |
| Amylase increased | Investigations | — |
Most-reported serious reactions: Platelet count decreased, Anaemia, Covid-19, Pneumonia, Asthenia, Covid-19 pneumonia, Gastrointestinal haemorrhage, Hepatic function abnormal.
Data from ClinicalTrials.gov NCT04989816 adverse events section.
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
8 peer-reviewed publications reference this trial (live from Europe PMC):
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