Zanidatamab Outcomes and Lived Experiences in Advanced HER2+ GEA

Condition(s) studied

Investigational drug(s) / intervention(s)

Zanidatamab: Administered via intravenous (IV) infusion

Study 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).

Eligibility

Primary outcome measure(s)

• 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
• 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

Trial sites (2)

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