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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05152147




Registration number
NCT05152147
Ethics application status
Date submitted
5/11/2021
Date registered
9/12/2021

Titles & IDs
Public title
A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers
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)
Secondary ID [1] 0 0
2021-000296-36
Secondary ID [2] 0 0
ZWI-ZW25-301
Universal Trial Number (UTN)
Trial acronym
HERIZON-GEA-01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastric Neoplasms 0 0
Gastroesophageal Adenocarcinoma 0 0
Esophageal Adenocarcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Zanidatamab
Treatment: Drugs - Tislelizumab
Treatment: Drugs - Trastuzumab
Treatment: Drugs - Capecitabine
Treatment: Drugs - Oxaliplatin
Treatment: Drugs - Cisplatin
Treatment: Drugs - 5-Fluorouracil

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

Experimental: Arm B - Zanidatamab plus physician's choice of CAPOX or FP

Experimental: Arm C - Zanidatamab and tislelizumab plus physician's choice of CAPOX or FP


Treatment: Drugs: Zanidatamab
Administered IV

Treatment: Drugs: Tislelizumab
Administered IV

Treatment: Drugs: Trastuzumab
Administered intravenously (IV)

Treatment: Drugs: Capecitabine
Administered orally (PO bid)

Treatment: Drugs: Oxaliplatin
Administered IV

Treatment: Drugs: Cisplatin
Administered IV

Treatment: Drugs: 5-Fluorouracil
Administered IV
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS) by BICR
Timepoint [1] 0 0
Up to 2.5 years
Primary outcome [2] 0 0
Overall survival
Timepoint [2] 0 0
Up to 3.5 years
Secondary outcome [1] 0 0
Confirmed objective response rate (ORR) by BICR
Timepoint [1] 0 0
Up to 2.5 years
Secondary outcome [2] 0 0
Duration of response (DOR) by BICR
Timepoint [2] 0 0
Up to 2.5 years
Secondary outcome [3] 0 0
PFS per Investigator assessment
Timepoint [3] 0 0
Up to 2.5 years
Secondary outcome [4] 0 0
Confirmed ORR per Investigator assessment
Timepoint [4] 0 0
Up to 2.5 years
Secondary outcome [5] 0 0
DOR per Investigator assessment
Timepoint [5] 0 0
Up to 2.5 years
Secondary outcome [6] 0 0
Assessment of Contribution of Components based on Progression-free Survival (PFS) by BICR
Timepoint [6] 0 0
Up to 2.5 years
Secondary outcome [7] 0 0
Assessment of Contribution of Components based on Overall Survival
Timepoint [7] 0 0
Up to 3.5 years
Secondary outcome [8] 0 0
Incidence of adverse events
Timepoint [8] 0 0
Up to 2 years
Secondary outcome [9] 0 0
Incidence of clinical laboratory abnormalities
Timepoint [9] 0 0
Up to 2 years
Secondary outcome [10] 0 0
Health-related quality of life (HRQoL) as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (core cancer questionnaire) C30 (QLQ-C30)
Timepoint [10] 0 0
Up to 2.5 years
Secondary outcome [11] 0 0
HRQoL as assessed by the EORTC Quality of Life Questionnaire (oesophago-gastric module) OG25 (QLQ-OG25)
Timepoint [11] 0 0
Up to 2.5 years
Secondary outcome [12] 0 0
HRQoL as assessed by the EuroQol 5-dimensions 5-levels (EQ-5D-5L) questionnaire
Timepoint [12] 0 0
Up to 2.5 years
Secondary outcome [13] 0 0
Serum concentration of zanidatamab and tislelizumab
Timepoint [13] 0 0
Up to 2 years
Secondary outcome [14] 0 0
Incidence of anti-drug antibodies (ADAs)
Timepoint [14] 0 0
Up to 2 years

Eligibility
Key inclusion criteria
* Histologically confirmed unresectable locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma (adenocarcinomas of the stomach or esophagus, including the gastroesophageal junction), defined as 3+ HER2 expression by IHC or 2+ HER2 expression by IHC with ISH positivity per central assessment. Subjects with esophageal adenocarcinoma must not be eligible for combined chemoradiotherapy at the time of enrollment
* Assessable (measurable or non-measurable) disease as defined by RECIST 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, assessed within 3 days prior to randomization
* Adequate organ function
* Left ventricular ejection fraction (LVEF) = 50% as determined by either echocardiogram or multiple gated acquisition scan (MUGA)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior treatment with a HER2-targeted agent, with the exception of subjects who received HER2-targeted treatment for breast cancer > 5 years prior to initial diagnosis of GEA
* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
* Prior treatment with systemic antineoplastic therapy or intraperitoneal chemotherapy for unresectable locally advanced, recurrent or metastatic GEA
* Untreated central nervous system (CNS) metastases, symptomatic CNS metastases, or radiation treatment for CNS metastases within 4 weeks prior to randomization. Stable, treated brain metastases are allowed (defined as subjects who are completely off steroids and anticonvulsants and are neurologically stable with no evidence of radiographic progression for at least 4 weeks prior to randomization)
* Known history of or ongoing leptomeningeal disease (LMD)
* Known additional malignancy that is not considered cured or that has required treatment within the past 3 years
* Known active hepatitis
* Any history of human immunodeficiency virus (HIV) infection
* Known SARS-CoV-2 infection; subjects with prior infection that has resolved per local institutions' requirements and screening guidance are eligible
* QTc Fridericia (QTcF) > 470 ms
* Clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension or any history of symptomatic congestive heart failure (CHF)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
918
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Border Medical Oncology Research Unit - Albury
Recruitment hospital [2] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 0 0
Austin Health - Heidelberg
Recruitment hospital [4] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [5] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
2170 - Liverpool
Recruitment postcode(s) [5] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
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Argentina
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Ciudad Autónoma de Buenos Aires
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Argentina
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Córdoba
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Argentina
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Pergamino
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San Miguel De Tucumán
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Viedma
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Belgium
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Bonheiden
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Belgium
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Brussels
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Belgium
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Gent
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Belgium
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Leuven
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Liège
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Bahia
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Rondonia
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Vitoria
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Recoleta
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Temuco
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Tallinn
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Bologna
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Kumamoto
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Chuo Ku
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Ina
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State/province [203] 0 0
Balçova
Country [204] 0 0
Turkey
State/province [204] 0 0
Bursa
Country [205] 0 0
Turkey
State/province [205] 0 0
Denizli
Country [206] 0 0
Turkey
State/province [206] 0 0
Diyarbakir
Country [207] 0 0
Turkey
State/province [207] 0 0
Edirne
Country [208] 0 0
Turkey
State/province [208] 0 0
Fatih
Country [209] 0 0
Turkey
State/province [209] 0 0
Izmir
Country [210] 0 0
Turkey
State/province [210] 0 0
Sariyer
Country [211] 0 0
Turkey
State/province [211] 0 0
Seyhan
Country [212] 0 0
Turkey
State/province [212] 0 0
Sur
Country [213] 0 0
Turkey
State/province [213] 0 0
Tarabya
Country [214] 0 0
Turkey
State/province [214] 0 0
Trabzon
Country [215] 0 0
Turkey
State/province [215] 0 0
Yenimahalle
Country [216] 0 0
Turkey
State/province [216] 0 0
Çankaya
Country [217] 0 0
Ukraine
State/province [217] 0 0
Dnipropetrovsk
Country [218] 0 0
Ukraine
State/province [218] 0 0
Kharkiv
Country [219] 0 0
Ukraine
State/province [219] 0 0
Kryvyi Rih
Country [220] 0 0
Ukraine
State/province [220] 0 0
Kyiv
Country [221] 0 0
Ukraine
State/province [221] 0 0
Lutsk
Country [222] 0 0
Ukraine
State/province [222] 0 0
Odesa
Country [223] 0 0
United Kingdom
State/province [223] 0 0
Bristol
Country [224] 0 0
United Kingdom
State/province [224] 0 0
Edinburgh
Country [225] 0 0
United Kingdom
State/province [225] 0 0
Leeds
Country [226] 0 0
United Kingdom
State/province [226] 0 0
London
Country [227] 0 0
United Kingdom
State/province [227] 0 0
Northwood
Country [228] 0 0
United Kingdom
State/province [228] 0 0
Peterborough
Country [229] 0 0
United Kingdom
State/province [229] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Jazz Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
BeiGene, Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Trial Disclosure & Transparency
Address 0 0
Country 0 0
Phone 0 0
215-832-3750
Fax 0 0
Email 0 0
ClinicalTrialDisclosure@JazzPharma.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05152147