Tracking HER2 mutations and treatment patterns in advanced non-small cell lung cancer in Italy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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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Where it's running

• Istituto Oncologico Veneto IRCCS
  Padova, Pd, Italy Recruiting
• Azienda Ospedaliera - Universitaria di Parma
  Parma, Pr, Italy Recruiting
• 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

Study contacts

• Study coordinator: Marcello Tiseo, MD, PhD
• Email: goirc-heros@goirc.org
• Phone: +390521704465

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.