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

March 4, 2026 updated by: Gruppo Oncologico Italiano di Ricerca Clinica

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • BA
      • Bari, BA, Italy, 70124
        • Active, not recruiting
        • IRCCS "Giovanni Paolo II"
    • FC
      • Meldola, FC, Italy, 47014
        • Not yet recruiting
        • Istituto Romagnolo per lo Studio dei Tumori IRST "Dino Amadori"
        • Contact:
          • Kalliopi Andrikou, MD
    • FE
      • Ferrara, FE, Italy, 44124
        • Not yet recruiting
        • Arcispedale Sant'Anna
        • Contact:
          • Luana Calabrò, MD
    • GE
      • Genova, GE, Italy, 16132
        • Not yet recruiting
        • Ospedale Policlinico San Martino
        • Contact:
          • Carlo Genova, MD
    • LU
      • Lido di Camaiore, LU, Italy, 55041
        • Active, not recruiting
        • Ospedale Versilia
      • Lucca, LU, Italy, 55100
        • Active, not recruiting
        • Azienda Sanitaria Toscana Nord - Ovest
    • MB
      • Monza, MB, Italy, 20900
        • Not yet recruiting
        • Irccs San Gerardo Dei Tintori
        • Contact:
          • Diego Luigi Cortinovis, MD
    • MI
      • Milan, MI, Italy, 20132
        • Not yet recruiting
        • IRCCS Ospedale San Raffaele
        • Contact:
          • Alessandra Bulotta, MD
      • Milan, MI, Italy, 20162
        • Not yet recruiting
        • ASST Grande Ospedale Metropolitano Niguarda
        • Contact:
          • Giulio Cerea, MD
      • Rozzano, MI, Italy, 20089
        • Not yet recruiting
        • Istituto Clinico Humanitas IRRCS
        • Contact:
          • Luca Toschi, MD
    • MO
      • Modena, MO, Italy, 41125
        • Active, not recruiting
        • Azienda Ospedaliero - Universitaria di Modena
    • PD
      • Padua, PD, Italy, 35128
        • Recruiting
        • Istituto Oncologico Veneto IRCCS
        • Contact:
          • Giulia Pasello, MD
    • PG
      • Perugia, PG, Italy, 06129
        • Active, not recruiting
        • Azienda Ospedaliera di Perugia
    • PN
      • Aviano, PN, Italy, 33081
        • Not yet recruiting
        • Centro di Riferimento Oncologico IRCCS di Aviano
        • Contact:
          • Brigida Stanzione, MD
    • PR
      • Parma, PR, Italy, 43126
        • Recruiting
        • Azienda Ospedaliera - Universitaria di Parma
        • Contact:
          • Alessandro Leonetti, MD
    • PV
      • Pavia, PV, Italy, 27100
        • Not yet recruiting
        • Fondazione IRCCS Policlinico S. Matteo
        • Contact:
          • Francesco Augustoni, MD
    • RE
      • Reggio Emilia, RE, Italy, 42122
        • Active, not recruiting
        • Azienda Ospedaliero - Universitaria di Reggio Emilia
    • RM
      • Roma, RM, Italy, 00144
        • Not yet recruiting
        • Istituto Nazionale dei Tumori Regina Elena IRCCS - IFO
        • Contact:
          • Federico Cappuzzo, MD
      • Roma, RM, Italy, 00152
        • Active, not recruiting
        • Azienda Ospedaliera San Camillo Forlanini
    • TO
      • Orbassano, TO, Italy, 10043
        • Not yet recruiting
        • AOU San Luigi Orbassano
        • Contact:
          • Silvia Novello, MD
    • UD
      • Udine, UD, Italy, 33100
        • Not yet recruiting
        • Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)
        • Contact:
          • Giacomo Pelizzari, MD
    • VR
      • Verona, VR, Italy, 37126
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Integrata Verona
        • Contact:
          • Sara Pilotto, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with HER2-mutated advanced non-small cell lung cancer

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of HER2 mutation
Time Frame: 1 year
Percentage of advanced NSCLC with HER2 mutations in Italy clinical practice.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Oncologico Italiano di Ricerca Clinica

Collaborators

AstraZeneca

Investigators

  • Study Director: Marcello Tiseo, MD, PhD, Gruppo Oncologico Italiano di Ricerca Clinica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2025

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

January 14, 2025

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOIRC-01-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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