Observational, Prospective, Multi-centric Study Exploring HER2 Mutations Incidence and Therapeutic Management in aNSCLC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: NSCLC (Advanced Non-small Cell Lung Cancer), HER2. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
HER2 in Advanced NSCLC: an Observational, Prospective, Multi-centric Study Exploring HER2 Mutations Incidence and Therapeutic Management in Italy. The HEROS Study - GOIRC-01-2022
Overview
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.
Detailed 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.
Primary outcome measures
- Prevalence of HER2 mutation [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
Cohort 1 (Prevalence study population)
- Male or female, aged at least 18 years.
- Pathologically confirmed diagnosis of NSCLC from September 2024 to September 2025.
- Locally advanced (IIIC), not amenable to multimodal approach (chemo-radiotherapy), or metastatic (IV) NSCLC according to TNM VIII edition.
- Enrolled in ATLAS project. Cohort 2 (HER2 mutations study population)
- Included in Cohort 1.
- Presence of HER2 mutation.
- Enrolled in ATLAS project. Cohort 3 (Prospective Biomarker Analysis population)
- Included in Cohort 2.
- Availability of tissue sample from the first 50 patients enrolled in cohort 2.
- Written informed consent (HEROS project) must be obtained before any study-related procedure.
Exclusion criteria
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 22 centers
- IRCCS "Giovanni Paolo II" — Bari
- Istituto Romagnolo per lo Studio dei Tumori IRST "Dino Amadori" — Meldola
- Arcispedale Sant'Anna — Ferrara
- Ospedale Policlinico San Martino — Genova
- Ospedale Versilia — Lido di Camaiore
- Azienda Sanitaria Toscana Nord - Ovest — Lucca
- IRCCS San Gerardo dei Tintori — Monza
- IRCCS Ospedale San Raffaele — Milan
- … and 14 more centers
Identifiers
NCT: NCT07356544 · GOIRC-01-2022