Zanidatamab
DrugAdministered via intravenous (IV) infusion
Other names: ZW25, JZP598, ZIIHERA®
NCT Number: NCT07780968
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).
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
UCI Health - Chao Family Comprehensive Cancer Center, Orange, California, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered via intravenous (IV) infusion
Other names: ZW25, JZP598, ZIIHERA®
Time frame: Baseline
Time frame: Baseline
The number of participants at each demographic category: sex, race and ethnicity
Time frame: Baseline
Number of participants at each Eastern Cooperative Oncology Group (ECOG) performance status, comorbidities, and GI symptoms
Time frame: Baseline
Participants' average body mass index (BMI) in kilogram per square meters
Time frame: Baseline
Participants' average body surface area (BSA) in square meters
Time frame: Baseline
Average Ejection Fraction (EF) and Left Ventricular Ejection Fraction (LVEF) as determined by ECHO or MUGA reported as a percentage
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
Time frame: Baseline
Treatment history will be defined as the number of participants with previous surgical resection, and adjuvant or neoadjuvant treatments
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).
Time frame: Up to 5 years
Number of participants who took chemotherapy or immunotherapy in combination with first line zanidatamab-containing therapy
Time frame: Up to 5 years
The average dose of zanidatamab per cycle and first line zanidatamab-containing therapy
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
Time frame: Up to 5 years
Time frame: Up to 5 years
Time frame: Up to 5 years
Time frame: Up to 5 years
Time frame: Up to 5 years
Time frame: Up to 5 years
Number of participants at each reason for treatment discontinuation, interruption and/or chemotherapy dose adjustment
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
Time frame: Up to 5 years
Duration of the AESI, including the first and subsequent incidence of diarrhea
Time frame: Up to 5 years
Time (by treatment cycle) where the onset of AESI and the first and following incidences of diarrhea occurred
Time frame: Up to 5 years
Time (by treatment cycle) adjustment for chemotherapy, immunotherapy agent or zanidatamab due to diarrhea and AESI
Time frame: Up to 5 years
Time frame: Up to 5 years
Time of dose (by treatment cycle) where supportive therapy for AESI and additional therapy for diarrhea was initiated
Time frame: Up to 5 years
Number of participants at each category of causality of AESI, including diarrhea
Time frame: Up to 5 years
Number of participants at each category of resolution of AESI, including diarrhea
Time frame: Up to 5 years
Number of participants that had to initiate additional supportive therapy due to AESI and/or diarrhea
Time frame: Up to 5 years
Number of new metastatic site by location
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
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
Time frame: Up to 5 years
rwP is defined as the proportion of participants with clinician documentation or radiologic evidence of disease worsening
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
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
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
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
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.
Contact information is provided by the study sponsor or research team.
Jazz Pharmaceuticals
Industry
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
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.
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