Tracking HER2 mutations and treatment patterns in advanced non-small cell lung cancer in Italy
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
This project will see how people in Italy with advanced NSCLC and HER2 mutations are diagnosed and treated over a one-year follow-up period.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gruppo Oncologico Italiano di Ricerca Clinica Academic / other |
| Locations | 22 sites (Bari, BA and 21 other locations) |
| Trial ID | NCT07356544 on ClinicalTrials.gov |
What this trial studies
HEROS is a prospective, multicenter observational effort nested within the Italian ATLAS project that will use aggregated ATLAS data to quantify the prevalence of HER2 mutations among newly diagnosed advanced NSCLC patients from September 2024 to September 2025. Approximately 100 HER2-mutated patients will be examined for treatment patterns and outcomes, while a subset of about 25 centers will enroll patients for prospective biomarker analyses on available tissue and blood samples. Data collection spans initial diagnosis through a 12-month follow-up window and leverages the ATLAS database covering roughly 59 centers and ~5,000 new advanced NSCLC cases per year. No interventional treatments are assigned; the work documents real-world diagnostic and therapeutic management.
Who should consider this trial
Good fit: Adults (≥18 years) in Italy with newly diagnosed locally advanced (IIIC) or metastatic (IV) NSCLC who are enrolled in the ATLAS project, and specifically those with confirmed HER2 mutations and available tissue for the biomarker subset, are ideal candidates.
Not a fit: Patients without HER2 mutations, those not enrolled in the ATLAS network, or those unable to provide tissue samples or consent are unlikely to derive direct benefit from this project's findings.
Why it matters
Potential benefit: If successful, the project could help improve detection and treatment choices for patients with HER2-mutated advanced NSCLC by clarifying real-world practices and outcomes.
How similar studies have performed: Targeted therapies for HER2-mutant NSCLC have shown promising efficacy in clinical trials, but comprehensive, multicenter real-world descriptions of diagnostic and therapeutic practice in Italy remain relatively limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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: \-
Where this trial is running
Bari, BA and 21 other locations
- IRCCS "Giovanni Paolo II" — Bari, Ba, Italy (Active_not_recruiting)
- Istituto Romagnolo per lo Studio dei Tumori IRST "Dino Amadori" — Meldola, Fc, Italy (Not_yet_recruiting)
- Arcispedale Sant'Anna — Ferrara, Fe, Italy (Not_yet_recruiting)
- Ospedale Policlinico San Martino — Genova, Ge, Italy (Not_yet_recruiting)
- Ospedale Versilia — Lido di Camaiore, Lu, Italy (Active_not_recruiting)
- Azienda Sanitaria Toscana Nord - Ovest — Lucca, Lu, Italy (Active_not_recruiting)
- IRCCS San Gerardo dei Tintori — Monza, Mb, Italy (Not_yet_recruiting)
- IRCCS Ospedale San Raffaele — Milan, Mi, Italy (Not_yet_recruiting)
- ASST Grande Ospedale Metropolitano Niguarda — Milan, Mi, Italy (Not_yet_recruiting)
- Istituto Clinico Humanitas IRRCS — Rozzano, Mi, Italy (Not_yet_recruiting)
- Azienda Ospedaliero - Universitaria di Modena — Modena, Mo, Italy (Active_not_recruiting)
- Istituto Oncologico Veneto IRCCS — Padova, Pd, Italy (Recruiting)
- Azienda Ospedaliera di Perugia — Perugia, Pg, Italy (Active_not_recruiting)
- Centro di Riferimento Oncologico IRCCS di Aviano — Aviano, Pn, Italy (Not_yet_recruiting)
- Azienda Ospedaliera - Universitaria di Parma — Parma, Pr, Italy (Recruiting)
- Fondazione IRCCS Policlinico S. Matteo — Pavia, Pv, Italy (Not_yet_recruiting)
- Azienda Ospedaliero - Universitaria di Reggio Emilia — Reggio Emilia, Re, Italy (Active_not_recruiting)
- Istituto Nazionale dei Tumori Regina Elena IRCCS - IFO — Roma, Rm, Italy (Not_yet_recruiting)
- Azienda Ospedaliera San Camillo Forlanini — Roma, Rm, Italy (Active_not_recruiting)
- AOU San Luigi Orbassano — Orbassano, To, Italy (Not_yet_recruiting)
- Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) — Udine, Ud, Italy (Not_yet_recruiting)
- Azienda Ospedaliera Universitaria Integrata Verona — Verona, Vr, Italy (Not_yet_recruiting)
Study contacts
- Study coordinator: Marcello Tiseo, MD, PhD
- Email: goirc-heros@goirc.org
- Phone: +390521704465
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.