Clinical trial · Observational
Zanidatamab Outcomes and Lived Experiences in Advanced HER2+ GEA
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| GastroEsophageal Cancer | — | UNRESOLVED | — |
| Gastroesophageal-junction Cancer | — | UNRESOLVED | — |
| HER2-positive Gastric Cancer | HER2-Positive Gastric Adenocarcinoma | ALIAS | 0.90 |
| Stomach Cancer | Malignant Gastric Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zanidatamab | Drug | Zanidatamab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Zanidatamab-containing Therapy
- description
- Participants with HER2-positive locally advanced or metastatic GEA initiating a zanidatamab-containing therapy as first line treatment as part of standard-of-care treatment
- interventionNames
- Drug: Zanidatamab
Primary outcomes (18)
- measure
- Average age of participants
- timeFrame
- Baseline
- measure
- Patient demographics
- timeFrame
- Baseline
- description
- The number of participants at each demographic category: sex, race and ethnicity
- measure
- Clinical characteristics
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available