CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 920 enrolled / 920 target
Drug / intervention
Zanidatamab +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05152147
NCT05152147Phase 3ActiveMonitor (16.7/mo)
CompareCT.gov

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)

Jazz Pharmaceuticals·interventional·Posted Dec 9, 2021·Updated Jun 30, 2026

In Brief

A Phase 3 clinical trial evaluating Zanidatamab, Tislelizumab, and 5 other interventions for Gastric Neoplasms and 2 related conditions. Active but no longer recruiting, targeting 920 participants across 227 sites in 33 countries.

Signals

Enrolling slower than its timeline implies

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Neoplasms, Gastroesophageal Adenocarcinoma, Esophageal Adenocarcinoma
CountriesArgentina, 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
CollaboratorsBeOne Medicines LTD, BeOne Pharmaceutical Co., Ltd.

Timeline

Phase 3Active
202220232024202520262027
First PostedDec 9, 2021
Enrollment StartDec 2, 2021
Primary CompletionJul 31, 2026
Study CompletionJul 31, 2027
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 4.6 years agoPrimary completion in 29 days

Arms & Interventions

Arm Aactive_comparator

Trastuzumab (Herceptin®) plus physician's choice of capecitabine plus oxaliplatin (CAPOX) or 5-fluorouracil (5-FU) plus cisplatin (FP)

Drug: TrastuzumabDrug: CapecitabineDrug: OxaliplatinDrug: CisplatinDrug: 5-Fluorouracil
Arm Bexperimental

Zanidatamab plus physician's choice of CAPOX or FP

Drug: ZanidatamabDrug: CapecitabineDrug: OxaliplatinDrug: CisplatinDrug: 5-Fluorouracil
Arm Cexperimental

Zanidatamab and tislelizumab plus physician's choice of CAPOX or FP

Drug: ZanidatamabDrug: TislelizumabDrug: CapecitabineDrug: OxaliplatinDrug: CisplatinDrug: 5-Fluorouracil

Interventions

Zanidatamabdrug

Administered IV

Tislelizumabdrug

Administered IV

Trastuzumabdrug

Administered intravenously (IV)

Capecitabinedrug

Administered orally (PO bid)

Oxaliplatindrug

Administered IV

Cisplatindrug

Administered IV

5-Fluorouracildrug

Administered IV