HER2 Aberrations in EGFR Mutation-Positive Lung Cancer:Clinical Landscape, EGFR-TKI Efficacy, and Prognostic Impact(HERITAGE study)

HER2 Aberrations in EGFR Mutation-Positive Lung Cancer:Clinical Landscape, EGFR-TKI Efficacy, and Prognostic Impact(HERITAGE study) - HERITAGE study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000056986

Enrollment

350

Registered

2025-02-10

Start date

2025-03-31

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer Harbouring EGFR mutation

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who are evaluable for HER2 aberrations using formalin-fixed paraffin-embedded (FFPE) tumor specimens collected before EGFR-TKI therapy, from among all patients enrolled in OSI-FACT study.

Exclusion criteria

Exclusion criteria: Patients considered inappropriate by the treating physician for any reason, such as inability to collect information required for CRF completion.

Design outcomes

Primary

Measure	Time frame
HER2 amplification/expression rate in patients with EGFR mutation-positive lung cancer Progression-free survival (PFS) by HER2 expression level	—

Secondary

Measure	Time frame
Time to treatment failure (TTF), objective response rate (ORR), and overall survival (OS) by HER2 expression level HER2 protein overexpression frequency Concordance rate between HER2 IHC and FISH	—

Countries

Japan

Contacts

Public ContactTatsunori Ito

HOPE HOPE

tatsunori.ito.b1@tohoku.ac.jp022-717-8539

Outcome results