Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07780968

Zanidatamab Outcomes and Lived Experiences in Advanced HER2+ GEA

The purpose of this study is to collect real-world data to describe the effectiveness and tolerability of first line zanidatamab-containing therapies and describe the subsequent lines of treatment in participants with unresectable, locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma (GEA).

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UCI Health - Chao Family Comprehensive Cancer Center, Orange, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed HER2-positive (defined as IHC3+ or IHC2+ with ISH positivity) locally advanced or metastatic GEA (HER2+ la/m GEA)
  • Documented plan to initiate a zanidatamab-containing therapy as first line (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

Exclusion criteria

  • 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

Treatment and study plan

Zanidatamab

Drug

Administered via intravenous (IV) infusion

Other names: ZW25, JZP598, ZIIHERA®

Primary outcomes

  1. Average age of participants

    Time frame: Baseline

  2. Patient demographics

    Time frame: Baseline

    The number of participants at each demographic category: sex, race and ethnicity

  3. Clinical characteristics

    Time frame: Baseline

    Number of participants at each Eastern Cooperative Oncology Group (ECOG) performance status, comorbidities, and GI symptoms

  4. Average BMI

    Time frame: Baseline

    Participants' average body mass index (BMI) in kilogram per square meters

  5. Average BSA

    Time frame: Baseline

    Participants' average body surface area (BSA) in square meters

  6. 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

  7. 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

  8. Treatment history

    Time frame: Baseline

    Treatment history will be defined as the number of participants with previous surgical resection, and adjuvant or neoadjuvant treatments

  9. Biomarkers

    Time frame: Baseline

    Number of participants at each PDL-1 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).

  10. 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

  11. Average dose of treatment

    Time frame: Up to 5 years

    The average dose of zanidatamab per cycle and first line zanidatamab-containing therapy

  12. 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

  13. Average duration of first line zanidatamab-containing therapy

    Time frame: Up to 5 years

  14. Number of participants at each HER2 status results after initiation of first line zanidatamab-containing therapy

    Time frame: Up to 5 years

  15. Average chemotherapy dose adjustment

    Time frame: Up to 5 years

  16. Duration of treatment interruption

    Time frame: Up to 5 years

  17. Number of participants at each subsequent line of therapy after treatment discontinuation

    Time frame: Up to 5 years

  18. 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

Secondary outcomes

  1. Incidence of AESI

    Time frame: Up to 5 years

    Incidence of adverse events of special interest (AESI), including diarrhea, associated with programmed cell death protein 1 (PD-1) antagonists

  2. Duration of the AESI

    Time frame: Up to 5 years

    Duration of the AESI, including the first and subsequent incidence of diarrhea

  3. Time (by treatment cycle) for the onset of AESI

    Time frame: Up to 5 years

    Time (by treatment cycle) where the onset of AESI and the first and following incidences of diarrhea occurred

  4. Time (by treatment cycle) of dose adjustment

    Time frame: Up to 5 years

    Time (by treatment cycle) adjustment for chemotherapy, immunotherapy agent or zanidatamab due to diarrhea and AESI

  5. Number of participants that adhered to prescribed diarrhea prophylaxis

    Time frame: Up to 5 years

  6. Time (by treatment cycle) of additional supportive therapy

    Time frame: Up to 5 years

    Time of dose (by treatment cycle) where supportive therapy for AESI and additional therapy for diarrhea was initiated

  7. Causality of AESI

    Time frame: Up to 5 years

    Number of participants at each category of causality of AESI, including diarrhea

  8. Resolution of AESI

    Time frame: Up to 5 years

    Number of participants at each category of resolution of AESI, including diarrhea

  9. Number of participants at each additional supportive therapy

    Time frame: Up to 5 years

    Number of participants that had to initiate additional supportive therapy due to AESI and/or diarrhea

  10. Number of new metastatic sites

    Time frame: Up to 5 years

    Number of new metastatic site by location

  11. Real world Objective Response Rate (rwORR)

    Time frame: Up to 5 years

    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

  12. Real world Tumor Response (rwR)

    Time frame: Up to 5 years

    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

  13. Real world Disease Progression (rwP)

    Time frame: Up to 5 years

    rwP is defined as the proportion of participants with clinician documentation or radiologic evidence of disease worsening

  14. Real world Progression Free Survival (rwPFS)

    Time frame: Up to 5 years

    rwPFS is defined as the time (in months) from the initiation of 1L zanidatamab-containing therapy until the first occurrence of documented disease progression or death

  15. Real world Progression Free Survival on Second line Therapy (rwPFS2)

    Time frame: Up to 5 years

    rwPFS2 is defined as the time (in months) from the initiation of 1L zanidatamab-containing therapy until the date of first documented disease progression on the subsequent line of therapy, or death, whichever occurs first

  16. Real world Duration of Response (rwDoR)

    Time frame: Up to 5 years

    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

  17. Overall survival

    Time frame: Up to 5 years

    Overall survival (OS) is defined as the time (in months) from the initiation of 1L zanidatamab-containing therapy until death

  18. 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

    European Organization for Research and Treatment of Cancer (EORTC) Item Library 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trial Disclosure & Transparency

CONTACT

[email protected]

215-832-3750

Sponsors and collaborators

Lead sponsor

Jazz Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: ZOLA

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Aug 24, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.