Zanidatamab Outcomes and Lived Experiences in Advanced HER2+ GEA

Browse trials for

• Esophageal Neoplasms 1,591
• Stomach Neoplasms 2,842

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

Study population

Groups and cohorts

• 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

  Drug: Zanidatamab

Interventions

• DrugZanidatamab

  Administered via intravenous (IV) infusion

  Also known as: ZW25, JZP598, ZIIHERA®

Primary outcomes

1. Average age of participants

   Time frame: Baseline

2. Patient demographics

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

   Time frame: Baseline

3. Clinical characteristics

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

   Time frame: Baseline

4. Average BMI

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

   Time frame: Baseline

5. Average BSA

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

   Time frame: Baseline

6. Heart Function

   Average Ejection Fraction (EF) and Left Ventricular Ejection Fraction (LVEF) as determined by ECHO or MUGA reported as a percentage

   Time frame: Baseline

7. 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

   Time frame: Baseline

8. Treatment history

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

   Time frame: Baseline

9. 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).

   Time frame: Baseline

10. 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

    Time frame: Up to 5 years

11. Average dose of treatment

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

    Time frame: Up to 5 years

12. Cycles of treatment

    Number of planned cycles of first line zanidatamab-containing therapy and actual number of cycles of first line zanidatamab-containing therapy

    Time frame: Up to 5 years

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

    Number of participants at each reason for treatment discontinuation, interruption and/or chemotherapy dose adjustment

    Time frame: Up to 5 years

Secondary outcomes

1. Incidence of AESI

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

   Time frame: Up to 5 years

2. Duration of the AESI

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

   Time frame: Up to 5 years

3. 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

   Time frame: Up to 5 years

4. Time (by treatment cycle) of dose adjustment

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

   Time frame: Up to 5 years

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

   Time frame: Up to 5 years

7. Causality of AESI

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

   Time frame: Up to 5 years

8. Resolution of AESI

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

   Time frame: Up to 5 years

9. Number of participants at each additional supportive therapy

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

   Time frame: Up to 5 years

10. Number of new metastatic sites

    Number of new metastatic site by location

    Time frame: Up to 5 years

11. 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

    Time frame: Up to 5 years

12. 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

    Time frame: Up to 5 years

13. Real world Disease Progression (rwP)

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

    Time frame: Up to 5 years

14. Real world Progression Free Survival (rwPFS)

    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

    Time frame: Up to 5 years

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

    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

    Time frame: Up to 5 years

16. 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

    Time frame: Up to 5 years

17. Overall survival

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

    Time frame: Up to 5 years

18. 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.

    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

Individual participant data

Plan to share: 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.