Esophageal CancerZOLANCT07780968
Zanidatamab Outcomes and Lived Experiences in Advanced HER2+ GEA
An observational study of Esophageal Cancer and GastroEsophageal Cancer, run by Jazz Pharmaceuticals at 2 sites in United States.
Trial summary
The purpose of this study is to collect real-world data to describe the effectiveness and tolerability of first line (1L) zanidatamab-containing therapies and describe the subsequent lines of treatment in participants with unresectable, locally advanced, recurrent or metastatic HER2-positive gastroesophageal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, GastroEsophageal Cancer, Gastroesophageal-junction Cancer
- What is being tested?
- Zanidatamab
- Type of treatment
- Injection or infusion
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Nov 2026to 1 Oct 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will enroll approximately 300 male and female participants, aged 18 years or older in the United States, diagnosed with HER2-positive locally advanced or metastatic GEA with a plan to initiate a 1L zanidatamab-containing therapy.
Who may be able to join
- Histologically confirmed HER2-positive (defined as IHC3+ or IHC2+ with ISH positivity) locally advanced or metastatic GEA
- Documented plan to initiate a zanidatamab-containing therapy as 1L treatment
- Sufficient cognitive capacity and language proficiency to complete patient-reported outcomes (PRO) questions
- 18 years of age or older on the date of initiating 1L zanidatamab-containing therapy
Who cannot join
- Receiving a zanidatamab-containing therapy as part of a clinical trial or expanded access program
- Received zanidatamab prior to the approval date by the FDA for HER2+ la/m GEA
- Received the first infusion of zanidatamab prior to providing study consent
- For patients initiating chemotherapy backbone first, more than 2 months have elapsed before the first dose of zanidatamab
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of Texas - MD Anderson Cancer Center Gastrointestinal Cancer Center
Houston, Texas, 77030
UCI Health - Chao Family Comprehensive Cancer Center
Orange, California, 92868
About this study
Official title: Real-World Utilization, Treatment Patterns, Tolerability, and Effectiveness of Zanidatamab in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HER2-Positive Gastroesophageal Adenocarcinoma in the United States
The purpose of this study is to collect real-world data to describe the effectiveness and tolerability of first line (1L) zanidatamab-containing therapies and describe the subsequent lines of treatment in participants with unresectable, locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma (GEA) (HER2+ la/m GEA).
- Conditions
- Esophageal Cancer, GastroEsophageal Cancer, Gastroesophageal-junction Cancer, HER2-positive Gastric Cancer, Stomach Cancer
- Being tested
- Zanidatamab
- Keywords
- JZP598, ZIIHERA, Zanidatamab, GEA, HER2-positive gastroesophageal cancer, HER2-positive gastric cancer, HER2-positive esophageal cancer, HER2-positive GEA, HER2-positive stomach cancer, HER2-positive gastroesophageal junction cancer
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanidatamabDrug
Also called ZW25, JZP598, ZIIHERA®
Administered via intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| Zanidatamab-containing Therapy | Participants with HER2-positive locally advanced or metastatic GEA initiating a zanidatamab-containing therapy as first line treatment as part of standard-of-care treatment Receives: Drug: Zanidatamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average age of participants
Measured: Baseline
Patient demographics
The number of participants at each demographic category: sex, race and ethnicity
Measured: Baseline
Clinical characteristics
Number of participants at each Eastern Cooperative Oncology Group (ECOG) performance status, comorbidities, and gastrointestinal symptoms
Measured: Baseline
Average BMI
Participants' average body mass index (BMI) in kilogram per square meters
Measured: Baseline
Average BSA
Participants' average body surface area (BSA) in square meters
Measured: Baseline
Heart Function
Average Ejection Fraction (EF) and Left Ventricular Ejection Fraction (LVEF) as determined by ECHO or MUGA reported as a percentage
Measured: Baseline
Diagnostic history
Number of participants at each initial diagnosis stage, TNM (tumor, nodes and metastasis) and clinical staging (metastatic, locally advanced, unresectable), disease subtype (gastric, esophageal or gastroesophageal) and metastatic sites by location
Measured: Baseline
Treatment history
Treatment history will be defined as the number of participants with previous surgical resection, and adjuvant or neoadjuvant treatments
Measured: Baseline
Biomarkers
Number of participants at each Programmed death-ligand 1 (PD-L1) expression category (through tumor area positivity (TAP) and combined positive score (CPS) scoring), HER2 amplification and expression results status via immunohistochemistry (IHC) or next generation sequencing (NGS).
Measured: Baseline
Number of participants taking a treatment in combination with first line zanidatamab-containing therapy
Number of participants who took chemotherapy or immunotherapy in combination with first line zanidatamab-containing therapy
Measured: Up to 5 years
Average dose of treatment
The average dose of zanidatamab per cycle and first line zanidatamab-containing therapy
Measured: Up to 5 years
Cycles of treatment
Number of planned cycles of first line zanidatamab-containing therapy and actual number of cycles of first line zanidatamab-containing therapy
Measured: Up to 5 years
Average duration of first line zanidatamab-containing therapy
Measured: Up to 5 years
Number of participants at each HER2 status results after initiation of first line zanidatamab-containing therapy
Measured: Up to 5 years
Average chemotherapy dose adjustment
Measured: Up to 5 years
Duration of treatment interruption
Measured: Up to 5 years
Number of participants at each subsequent line of therapy after treatment discontinuation
Measured: Up to 5 years
Reason of treatment adjustment
Number of participants at each reason for treatment discontinuation, interruption and/or chemotherapy dose adjustment
Measured: Up to 5 years
Secondary outcomes (18)
Incidence of AESI
Incidence of adverse events of special interest (AESI), including diarrhea, associated with programmed cell death protein 1 (PD-1) antagonists
Measured: Up to 5 years
Duration of the AESI
Duration of the AESI, including the first and subsequent incidence of diarrhea
Measured: Up to 5 years
Time (by treatment cycle) for the onset of AESI
Time (by treatment cycle) where the onset of AESI and the first and following incidences of diarrhea occurred
Measured: Up to 5 years
Time (by treatment cycle) of dose adjustment
Time (by treatment cycle) adjustment for chemotherapy, immunotherapy agent or zanidatamab due to diarrhea and AESI
Measured: Up to 5 years
Number of participants that adhered to prescribed diarrhea prophylaxis
Measured: Up to 5 years
Time (by treatment cycle) of additional supportive therapy
Time of dose (by treatment cycle) where supportive therapy for AESI and additional therapy for diarrhea was initiated
Measured: Up to 5 years
Causality of AESI
Number of participants at each category of causality of AESI, including diarrhea
Measured: Up to 5 years
Resolution of AESI
Number of participants at each category of resolution of AESI, including diarrhea
Measured: Up to 5 years
Number of participants at each additional supportive therapy
Number of participants that had to initiate additional supportive therapy due to AESI and/or diarrhea
Measured: Up to 5 years
Number of new metastatic sites
Number of new metastatic site by location
Measured: Up to 5 years
Real world Objective Response Rate (rwORR)
rwORR is defined as the proportion of participants with a best overall response of Complete Response (CR) or Partial Response (PR) to 1L zanidatamab-containing therapy
Measured: Up to 5 years
Real world Tumor Response (rwR)
rwR will be reported as real-world complete response (rwCR) which is the proportion of participants with complete clearance of tumor and real-world partial response (rwPR) which is the proportion of participants with reduced tumor burden
Measured: Up to 5 years
Real world Disease Progression (rwP)
rwP is defined as the proportion of participants with clinician documentation or radiologic evidence of disease worsening
Measured: Up to 5 years
Real world Progression Free Survival (rwPFS)
rwPFS is defined as the time (in months) from the initiation of 1L zanidatamabcontaining therapy until the first occurrence of documented disease progression or death
Measured: Up to 5 years
Real world Progression Free Survival on Second line Therapy (rwPFS2)
rwPFS2 is defined as the time (in months) from the initiation of 1L zanidatamabcontaining therapy until the date of first documented disease progression on the subsequent line of therapy, or death, whichever occurs first
Measured: Up to 5 years
Real world Duration of Response (rwDoR)
rwDoR is defined as the time (in months) from first real world CR or real world PR to the first documented real world disease progression or death
Measured: Up to 5 years
Overall survival
Overall survival (OS) is defined as the time (in months) from the initiation of 1L zanidatamab-containing therapy until death
Measured: Up to 5 years
EORTC IL 66 scores
European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 66 (EORTC IL 66) includes EORTC Item library 19 (EORTC IL 19) and EORTC global health status (GHS)/quality of life (QoL) (EORTC GHS/QoL).
EORTC IL 19 is a 5-item scale that assesses the physical functioning domain of health-related quality of life (HRQoL). It has a total score ranging from 0 to 100 with a higher score indicating better level of physical functioning.
EORTC GHS/QoL is a 2-item scale with a total score ranging from 0 to 100 with a higher score indicating better level of overall well-being and HRQoL.
Measured: At Baseline, At Day 15, At 1 month, At 3 months, At 6 months, At 12 months, At 18 months, At 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start30 Nov 2026 (estimated)
- Primary completion1 Oct 2031 (estimated)
- Study completion1 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07780968
- Sponsor's protocol ID
- JZP598-401
- Acronym
- ZOLA
- Status last verified
- Oct 2026
- First submitted
- 19 Aug 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy contact clinicaldatasharing@jazzpharma.com.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Utilization, Treatment Patterns, Tolerability, and Effectiveness of Zanidatamab in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HER2-Positive Gastroesophageal Adenocarcinoma in the United States
- ClinicalTrials.gov ID
- NCT07780968
- Acronym / sponsor ID
- ZOLA / JZP598-401
- Conditions
- Esophageal Cancer, GastroEsophageal Cancer, Gastroesophageal-junction Cancer, HER2-positive Gastric Cancer, Stomach Cancer
- Keywords
- JZP598, ZIIHERA, Zanidatamab, GEA, HER2-positive gastroesophageal cancer, HER2-positive gastric cancer, HER2-positive esophageal cancer, HER2-positive GEA
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 1 Oct 2031 (estimated)
- Study completion
- 1 Oct 2031 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to collect real-world data to describe the effectiveness and tolerability of first line (1L) zanidatamab-containing therapies and describe the subsequent lines of treatment in participants with unresectable, locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma (GEA) (HER2+ la/m GEA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zanidatamab-containing Therapy | – | Drug: ZanidatamabParticipants with HER2-positive locally advanced or metastatic GEA initiating a zanidatamab-containing therapy as first line treatment as part of standard-of-care treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll approximately 300 male and female participants, aged 18 years or older in the United States, diagnosed with HER2-positive locally advanced or metastatic GEA with a plan to initiate a 1L zanidatamab-containing therapy.
Key inclusion criteria (4 listed)
- Histologically confirmed HER2-positive (defined as IHC3+ or IHC2+ with ISH positivity) locally advanced or metastatic GEA
- Documented plan to initiate a zanidatamab-containing therapy as 1L treatment
- Sufficient cognitive capacity and language proficiency to complete patient-reported outcomes (PRO) questions
- 18 years of age or older on the date of initiating 1L zanidatamab-containing therapy
Key exclusion criteria (4 listed)
- Receiving a zanidatamab-containing therapy as part of a clinical trial or expanded access program
- Received zanidatamab prior to the approval date by the FDA for HER2+ la/m GEA
- Received the first infusion of zanidatamab prior to providing study consent
- For patients initiating chemotherapy backbone first, more than 2 months have elapsed before the first dose of zanidatamab
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZanidatamabAlso: ZW25, JZP598, ZIIHERA®Administered via intravenous (IV) infusion | Drug | Zanidatamab-containing Therapy |
Primary outcome
Average age of participants
Time frame: Baseline
Patient demographics
Time frame: Baseline
The number of participants at each demographic category: sex, race and ethnicity
Clinical characteristics
Time frame: Baseline
Number of participants at each Eastern Cooperative Oncology Group (ECOG) performance status, comorbidities, and gastrointestinal symptoms
Average BMI
Time frame: Baseline
Participants' average body mass index (BMI) in kilogram per square meters
Average BSA
Time frame: Baseline
Participants' average body surface area (BSA) in square meters
Heart Function
Time frame: Baseline
Average Ejection Fraction (EF) and Left Ventricular Ejection Fraction (LVEF) as determined by ECHO or MUGA reported as a percentage
Diagnostic history
Time frame: Baseline
Number of participants at each initial diagnosis stage, TNM (tumor, nodes and metastasis) and clinical staging (metastatic, locally advanced, unresectable), disease subtype (gastric, esophageal or gastroesophageal) and metastatic sites by location
Treatment history
Time frame: Baseline
Treatment history will be defined as the number of participants with previous surgical resection, and adjuvant or neoadjuvant treatments
Biomarkers
Time frame: Baseline
Number of participants at each Programmed death-ligand 1 (PD-L1) expression category (through tumor area positivity (TAP) and combined positive score (CPS) scoring), HER2 amplification and expression results status via immunohistochemistry (IHC) or next generation sequencing (NGS).
Number of participants taking a treatment in combination with first line zanidatamab-containing therapy
Time frame: Up to 5 years
Number of participants who took chemotherapy or immunotherapy in combination with first line zanidatamab-containing therapy
Average dose of treatment
Time frame: Up to 5 years
The average dose of zanidatamab per cycle and first line zanidatamab-containing therapy
Cycles of treatment
Time frame: Up to 5 years
Number of planned cycles of first line zanidatamab-containing therapy and actual number of cycles of first line zanidatamab-containing therapy
Average duration of first line zanidatamab-containing therapy
Time frame: Up to 5 years
Number of participants at each HER2 status results after initiation of first line zanidatamab-containing therapy
Time frame: Up to 5 years
Average chemotherapy dose adjustment
Time frame: Up to 5 years
Duration of treatment interruption
Time frame: Up to 5 years
Number of participants at each subsequent line of therapy after treatment discontinuation
Time frame: Up to 5 years
Reason of treatment adjustment
Time frame: Up to 5 years
Number of participants at each reason for treatment discontinuation, interruption and/or chemotherapy dose adjustment
18 secondary outcomes
Incidence of AESI
Time frame: Up to 5 years
Duration of the AESI
Time frame: Up to 5 years
Time (by treatment cycle) for the onset of AESI
Time frame: Up to 5 years
Time (by treatment cycle) of dose adjustment
Time frame: Up to 5 years
Number of participants that adhered to prescribed diarrhea prophylaxis
Time frame: Up to 5 years
Time (by treatment cycle) of additional supportive therapy
Time frame: Up to 5 years
Causality of AESI
Time frame: Up to 5 years
Resolution of AESI
Time frame: Up to 5 years
Number of participants at each additional supportive therapy
Time frame: Up to 5 years
Number of new metastatic sites
Time frame: Up to 5 years
Real world Objective Response Rate (rwORR)
Time frame: Up to 5 years
Real world Tumor Response (rwR)
Time frame: Up to 5 years
Real world Disease Progression (rwP)
Time frame: Up to 5 years
Real world Progression Free Survival (rwPFS)
Time frame: Up to 5 years
Real world Progression Free Survival on Second line Therapy (rwPFS2)
Time frame: Up to 5 years
Real world Duration of Response (rwDoR)
Time frame: Up to 5 years
Overall survival
Time frame: Up to 5 years
EORTC IL 66 scores
Time frame: At Baseline, At Day 15, At 1 month, At 3 months, At 6 months, At 12 months, At 18 months, At 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes. In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy contact clinicaldatasharing@jazzpharma.com.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer and GastroEsophageal Cancer, run by Jazz Pharmaceuticals at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Disclosure & Transparency (215-832-3750, ClinicalTrialDisclosure@JazzPharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average age of participants (time frame: Baseline). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.