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A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers

NCT05152147 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 920

Last updated 2026-05-19

No results posted yet for this study

Summary

This study is being done to find out if zanidatamab, when given with chemotherapy plus or minus tislelizumab, is safe and works better than trastuzumab given with chemotherapy.

The patients in this study will have advanced human epidermal growth factor 2 (HER2)-positive stomach and esophageal cancers that are no longer treatable with surgery (unresectable) or chemoradiation, and/or have grown or spread to other parts of the body (metastatic).

Conditions

  • Gastric Neoplasms
  • Gastroesophageal Adenocarcinoma
  • Esophageal Adenocarcinoma

Interventions

DRUG

Zanidatamab

Administered IV

DRUG

Tislelizumab

Administered IV

DRUG

Trastuzumab

Administered intravenously (IV)

DRUG

Capecitabine

Administered orally (PO bid)

DRUG

Oxaliplatin

Administered IV

DRUG

Cisplatin

Administered IV

DRUG

5-Fluorouracil

Administered IV

Sponsors & Collaborators

  • BeOne Medicines LTD

    collaborator UNKNOWN

  • BeOne Pharmaceutical Co., Ltd.

    collaborator UNKNOWN

  • Jazz Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-02
Primary Completion
2026-07-31
Completion
2027-07-31
FDA Drug
Yes

Countries

  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Chile
  • China
  • Estonia
  • France
  • Georgia
  • Germany
  • Greece
  • Guatemala
  • India
  • Ireland
  • Italy
  • Japan
  • Malaysia
  • Mexico
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Serbia
  • Singapore
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05152147 on ClinicalTrials.gov