Observational, Prospective, Multi-centric Study Exploring HER2 Mutations Incidence and Therapeutic Management in aNSCLC (HEROS)

Gruppo Oncologico Italiano di Ricerca Clinica

Status: Enrolling

Conditions: NSCLC (Advanced Non-small Cell Lung Cancer); HER2

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07356544

GOIRC-01-2022

Details and patient eligibility

About

The HEROS study is an Italian observational multicenter prospective study aimed to investigate the current diagnostic and therapeutical approach towards HER2 mutated NSCLC in clinical practice. The enrolment will start in September 2024 until September 2025. A 12-months follow-up window will be performed.

Full description

The HEROS study will be conducted in partnership with ATLAS project: all patients prospectively enrolled in ATLAS project will be used to fulfil primary and secondary objectives. Information will be obtained by querying ATLAS database (59 centers) in aggregated manner. ATLAS project is a multi-centric retrospective/prospective Italian study aimed to describe prevalence of different oncogene alterations in all new diagnosed advanced NSCLC patients (5,000 patients/year). In particular, prevalence of HER2-mutated patients will be calculated on all patients enrolled in ATLAS project. Approximately 100 HER2 mutated patients enrolled in ATLAS study will be studied for secondary and explorative objectives. Moreover, a subset of centers (25 centers) will enrol patients also for Prospective Biomarker Analysis in order to perform exploratory analysis on blood and tissue samples according to the availability of tissue specimens from the primary tumor or metastatic sites. All centers that will participate for Prospective Biomarker Analysis necessarily will be included into ATLAS project.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Cohort 1 (Prevalence study population)

1. Male or female, aged at least 18 years.
2. Pathologically confirmed diagnosis of NSCLC from September 2024 to September 2025.
3. Locally advanced (IIIC), not amenable to multimodal approach (chemo-radiotherapy), or metastatic (IV) NSCLC according to TNM VIII edition.
4. Enrolled in ATLAS project. Cohort 2 (HER2 mutations study population)
5. Included in Cohort 1.
6. Presence of HER2 mutation.
7. Enrolled in ATLAS project. Cohort 3 (Prospective Biomarker Analysis population)
8. Included in Cohort 2.
9. Availability of tissue sample from the first 50 patients enrolled in cohort 2.
10. Written informed consent (HEROS project) must be obtained before any study-related procedure.

Exclusion criteria

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Trial design