About this trial
This phase III study will assess the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with ramucirumab and paclitaxel (Ram + PTX) in participants with HER2-positive gastric or gastro-esophageal junction (GEJ) cancer who have progressed on or after a trastuzumab-containing treatment and have not received any additional systemic therapy. Trastuzumab deruxtecan (T-DXd) is a HER2 targeting antibody drug previously approved for use in HER2 positive breast cancers. While Ramucirumab and paclitaxel (Ram + PTX) is a second-line chemotherapy shown to improve survival of patients with advanced gastric or gastro-esophageal junction (GEJ) cancer. Participants will be randomized 1:1 to either T-DXd or Ram + PTX treatment. This is an open label, multicentre study.
|Suitable for patients with HER-2 positive metastatic and/or unresectable gastric or gasto-esophageal junction (GEJ) cancer|
Where’s this trial being run?
Beaumont Hospital, St James’s Hospital, and Tallaght University Hospital
Can I join this study / trial?
The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.
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A Phase 3 Multi centre, 2-arm randomised, open label study of trastuzamab deruxtecan in subjects with HER-2 positive metastatic and/or unresectable gastric or gasto-esophageal junction (GEJ) adenocarcinoma subjects whoh have progressed on or after a trastuzumab containing regimen.
|Principal Investigator:||Prof Patrick Morris (Beaumont Hospital), Prof Ray McDermott (Tallaght University Hospital), Prof Maeve Lowery (St. James' Hospital)|
Global: May 2021
Ireland: November 2021
|Global Recruitment Target:||490|
|Ireland Recruitment Target:||8-9|