This study is not yet accepting patients

Zanidatamab Outcomes and Lived Experiences in Advanced HER2+ GEA

a study on Esophageal Cancer Gastroesophageal Junction Cancer HER2 Stomach Cancer

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
study ends around

Description

Summary

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).

Official 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

Keywords

Esophageal Cancer, GastroEsophageal Cancer, Gastroesophageal-junction Cancer, HER2-positive Gastric Cancer, Stomach Cancer, JZP598, ZIIHERA, Zanidatamab, GEA, HER2-positive gastroesophageal cancer, HER2-positive esophageal cancer, HER2-positive GEA, HER2-positive stomach cancer, HER2-positive gastroesophageal junction cancer, Esophageal Neoplasms, Stomach Neoplasms, Zanidatamab-containing Therapy

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

  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

Locations

  • UCI Health - Chao Family Comprehensive Cancer Center
    Orange California 92868 United States
  • University of Texas - MD Anderson Cancer Center Gastrointestinal Cancer Center
    Houston Texas 77030 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Jazz Pharmaceuticals
ID
NCT07780968
Study Type
Observational
Participants
Expecting 300 study participants
Last Updated