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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gruppo Oncologico Italiano di Ricerca Clinica

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 12, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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