Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

HERIZON-GEA-01 : A Randomized, Multicenter, Phase 3 Study of Zanidatamab in Combination With Chemotherapy With or Without Tislelizumab in Subjects With HER2-positive Unresectable Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma (GEA)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Stomach<br/>CancersCancer LocationStomach
Cancers

Systemic therapy | Stomach and upper gastrointestinal tractGastro-oesophageal junction ,Oesophagus,Stomach

Trial Overview Read MoreRead more

This Phase III trial is seeking to find out if one targeted therapy (zanidatamab), when given with chemotherapy (capecitabine plus oxaliplatin or 5-fluorouracil plus cisplatin) with or without another targeted therapy (tislelizumab), is safe and works better than a different targeted therapy (trastuzumab) plus chemotherapy, in patients with HER2-positive cancers of the stomach or oesophagus .
 

This trial is treating patients with HER2-positive stomach and oesophagus cancers.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You have had treatment, but your cancer has come back.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Randomized, Multicenter, Phase 3 Study of Zanidatamab in Combination With Chemotherapy With or Without Tislelizumab in Subjects With HER2-positive Unresectable Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma (GEA)

Commercial Sponsor

Zymeworks Inc

Summary

This is a is a randomised trial with three arms. In the Arm A (Active Comparator), participants will receive Trastuzumab (administered intravenously [IV]) plus the physician's choice of capecitabine plus oxaliplatin (CAPOX) or 5-fluorouracil (5-FU) plus cisplatin (FP). In Arm B (Experimental), participants will receive Zanidatamab (administered via IV) plus physician's choice of CAPOX or FP. In Arm C (Experimental), participants will receive Zanidatamab and tislelizumab (administered via IV) plus physician's choice of CAPOX or FP. For all groups, Capecitabine will be administered orally (PO bid), while oxaliplatin, cisplatin and 5-fluorouracil will be administered via IV. Participants will be tested for HER2 gene-amplification using the ISH-based companion diagnostic assay, and also tested for HER2 protein-expression using the IHC-based companion diagnostic assay.

Recruiting Hospitals Read MoreRead more

Austin Health
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088

Border Medical Oncology
Albury
Ms Kate Oates
koates@bordermedonc.com.au
02 6064 1499

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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