Esophageal Cancer, GastroEsophageal Cancer, Gastroesophageal-junction Cancer, HER2-positive Gastric Cancer, Stomach Cancer
Conditions
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
Brief 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 adenocarcinoma (GEA) (HER2+ la/m GEA).
Interventions
DRUGZanidatamab
Administered via intravenous (IV) infusion
Sponsors
Jazz Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed HER2-positive (defined as IHC3+ or IHC2+ with ISH positivity) locally advanced or metastatic GEA 2. Documented plan to initiate a zanidatamab-containing therapy as 1L treatment 3. Sufficient cognitive capacity and language proficiency to complete patient-reported outcomes (PRO) questions 4. 18 years of age or older on the date of initiating 1L zanidatamab-containing therapy
Exclusion criteria
1. Receiving a zanidatamab-containing therapy as part of a clinical trial or expanded access program 2. Received zanidatamab prior to the approval date by the FDA for HER2+ la/m GEA 3. Received the first infusion of zanidatamab prior to providing study consent 4. For patients initiating chemotherapy backbone first, more than 2 months have elapsed before the first dose of zanidatamab
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants at each HER2 status results after initiation of first line zanidatamab-containing therapy | Up to 5 years | — |
| Average chemotherapy dose adjustment | Up to 5 years | — |
| Duration of treatment interruption | Up to 5 years | — |
| Number of participants at each subsequent line of therapy after treatment discontinuation | Up to 5 years | — |
| Reason of treatment adjustment | Up to 5 years | Number of participants at each reason for treatment discontinuation, interruption and/or chemotherapy dose adjustment |
| Average age of participants | Baseline | — |
| Patient demographics | Baseline | The number of participants at each demographic category: sex, race and ethnicity |
| Clinical characteristics | Baseline | Number of participants at each Eastern Cooperative Oncology Group (ECOG) performance status, comorbidities, and gastrointestinal symptoms |
| Average BMI | Baseline | Participants' average body mass index (BMI) in kilogram per square meters |
| Average BSA | Baseline | Participants' average body surface area (BSA) in square meters |
| Heart Function | Baseline | Average Ejection Fraction (EF) and Left Ventricular Ejection Fraction (LVEF) as determined by ECHO or MUGA reported as a percentage |
| Diagnostic history | 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 | Baseline | Treatment history will be defined as the number of participants with previous surgical resection, and adjuvant or neoadjuvant treatments |
| Biomarkers | 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 | Up to 5 years | Number of participants who took chemotherapy or immunotherapy in combination with first line zanidatamab-containing therapy |
| Average dose of treatment | Up to 5 years | The average dose of zanidatamab per cycle and first line zanidatamab-containing therapy |
| Cycles of treatment | 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 | Up to 5 years | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EORTC IL 66 scores | 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 (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. |
| Real world Progression Free Survival on Second line Therapy (rwPFS2) | 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 |
| Real world Duration of Response (rwDoR) | 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 |
| Overall survival | Up to 5 years | Overall survival (OS) is defined as the time (in months) from the initiation of 1L zanidatamab-containing therapy until death |
| Real world Disease Progression (rwP) | Up to 5 years | rwP is defined as the proportion of participants with clinician documentation or radiologic evidence of disease worsening |
| Incidence of AESI | Up to 5 years | Incidence of adverse events of special interest (AESI), including diarrhea, associated with programmed cell death protein 1 (PD-1) antagonists |
| Duration of the AESI | Up to 5 years | Duration of the AESI, including the first and subsequent incidence of diarrhea |
| Time (by treatment cycle) for the onset of AESI | Up to 5 years | Time (by treatment cycle) where the onset of AESI and the first and following incidences of diarrhea occurred |
| Time (by treatment cycle) of dose adjustment | Up to 5 years | Time (by treatment cycle) adjustment for chemotherapy, immunotherapy agent or zanidatamab due to diarrhea and AESI |
| Number of participants that adhered to prescribed diarrhea prophylaxis | Up to 5 years | — |
| Time (by treatment cycle) of additional supportive therapy | Up to 5 years | Time of dose (by treatment cycle) where supportive therapy for AESI and additional therapy for diarrhea was initiated |
| Causality of AESI | Up to 5 years | Number of participants at each category of causality of AESI, including diarrhea |
| Resolution of AESI | Up to 5 years | Number of participants at each category of resolution of AESI, including diarrhea |
| Number of participants at each additional supportive therapy | Up to 5 years | Number of participants that had to initiate additional supportive therapy due to AESI and/or diarrhea |
| Number of new metastatic sites | Up to 5 years | Number of new metastatic site by location |
| Real world Objective Response Rate (rwORR) | 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 |
| Real world Tumor Response (rwR) | 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 |
| Real world Progression Free Survival (rwPFS) | 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 |
Countries
United States
Contacts
CONTACTClinical Trial Disclosure & Transparency
Outcome results
None listed