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NCT07780968
Zanidatamab Outcomes and Lived Experiences in Advanced HER2+ GEA
Conditions: Esophageal Cancer, GastroEsophageal Cancer, Gastroesophageal-junction Cancer, HER2-positive Gastric Cancer, Stomach Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 300
Sponsor: Jazz Pharmaceuticals
Location: UCI Health - Chao Family Comprehensive Cancer Center Orange California
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).
Eligibility Criteria
Inclusion Criteria:
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
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
Source: ClinicalTrials.gov (NCT07780968). StuddyBuddy aggregates publicly available trial information.