AzTrials
AzTrials

NSCLC (Advanced Non-small Cell Lung Cancer)HEROSNCT07356544

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

An observational study of NSCLC (Advanced Non-small Cell Lung Cancer) and HER2, run by Gruppo Oncologico Italiano di Ricerca Clinica at 22 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
50 participants
Where
22 sitesItaly
Study dates
12 Aug 2025to 31 Jan 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with HER2-mutated advanced non-small cell lung cancer

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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.

Who cannot join

  • -

Trial locations and contacts

22 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Marcello Tiseo, MD, PhD contact

+390521704465

goirc-heros@goirc.org

Alessandro Leonetti, MD, PhD contact

info@goirc.org

22 sites in 1 country

Italy22 sites, 15 recruiting

  • Centro di Riferimento Oncologico IRCCS di Aviano

    Aviano, PN, 33081

    Brigida Stanzione, MD

    Not yet recruiting

  • IRCCS "Giovanni Paolo II"

    Bari, BA, 70124

    Active, not recruiting

  • Arcispedale Sant'Anna

    Ferrara, FE, 44124

    Luana Calabrò, MD

    Not yet recruiting

  • Ospedale Policlinico San Martino

    Genova, GE, 16132

    Carlo Genova, MD

    Not yet recruiting

  • Ospedale Versilia

    Lido di Camaiore, LU, 55041

    Active, not recruiting

  • Azienda Sanitaria Toscana Nord - Ovest

    Lucca, LU, 55100

    Active, not recruiting

  • Istituto Romagnolo per lo Studio dei Tumori IRST "Dino Amadori"

    Meldola, FC, 47014

    Kalliopi Andrikou, MD

    Not yet recruiting

  • IRCCS Ospedale San Raffaele

    Milan, MI, 20132

    Alessandra Bulotta, MD

    Not yet recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, MI, 20162

    Giulio Cerea, MD

    Not yet recruiting

  • Azienda Ospedaliero - Universitaria di Modena

    Modena, MO, 41125

    Active, not recruiting

  • IRCCS San Gerardo dei Tintori

    Monza, MB, 20900

    Diego Luigi Cortinovis, MD

    Not yet recruiting

  • AOU San Luigi Orbassano

    Orbassano, TO, 10043

    Silvia Novello, MD

    Not yet recruiting

  • Istituto Oncologico Veneto IRCCS

    Padova, PD, 35128

    Giulia Pasello, MD

    Recruiting

  • Azienda Ospedaliera - Universitaria di Parma

    Parma, PR, 43126

    Alessandro Leonetti, MD

    Recruiting

  • Fondazione IRCCS Policlinico S. Matteo

    Pavia, PV, 27100

    Francesco Augustoni, MD

    Not yet recruiting

  • Azienda Ospedaliera di Perugia

    Perugia, PG, 06129

    Active, not recruiting

  • Azienda Ospedaliero - Universitaria di Reggio Emilia

    Reggio Emilia, RE, 42122

    Active, not recruiting

  • Istituto Nazionale dei Tumori Regina Elena IRCCS - IFO

    Roma, RM, 00144

    Federico Cappuzzo, MD

    Not yet recruiting

  • Azienda Ospedaliera San Camillo Forlanini

    Roma, RM, 00152

    Active, not recruiting

  • Istituto Clinico Humanitas IRRCS

    Rozzano, MI, 20089

    Luca Toschi, MD

    Not yet recruiting

  • Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)

    Udine, UD, 33100

    Giacomo Pelizzari, MD

    Not yet recruiting

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, VR, 37126

    Sara Pilotto, MD

    Not yet recruiting

Other trials in Italy

About this study

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

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.

Read the 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.

Keywords
HER2 mutated
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of HER2 mutation

    Percentage of advanced NSCLC with HER2 mutations in Italy clinical practice.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2026
  2. Study start12 Aug 2025
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07356544
Sponsor's protocol ID
GOIRC-01-2022
Acronym
HEROS
Status last verified
Mar 2026
First submitted
14 Jan 2025
Last updated
5 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of NSCLC (Advanced Non-small Cell Lung Cancer) and HER2, run by Gruppo Oncologico Italiano di Ricerca Clinica at 22 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marcello Tiseo, MD, PhD (+390521704465, goirc-heros@goirc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of HER2 mutation (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07356544.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in