NCT05152147

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

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)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 920 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-12-02
• Primary completion: 2026-07-31
• Completion: 2027-07-31
• First posted: 2021-12-09
• Last updated: 2026-04-17

Locations

227 sites across 33 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

Regulatory

• FDA-regulated drug study