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Italian study maps HER2 mutations in advanced lung cancer

NCT ID NCT07356544

Knowledge-focused Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This observational study will track 50 people with advanced non-small cell lung cancer (NSCLC) in Italy to see how common HER2 mutations are and how doctors currently treat them. Participants will be followed for one year. The goal is to understand real-world care, not to test a new treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could reveal how common HER2 mutations are in Italian advanced NSCLC patients and how doctors currently treat them, guiding future research and care.
What could go wrong
This is an observational study, not a treatment trial. It will not test any new drug or therapy, so it cannot directly improve outcomes. Results may not apply outside Italy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HER2 NSCLC (advanced non-small cell lung cancer)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    15 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AOU San Luigi Orbassano

    NOT_YET_RECRUITING

    Orbassano, TO, 10043, Italy

  • ASST Grande Ospedale Metropolitano Niguarda

    NOT_YET_RECRUITING

    Milan, MI, 20162, Italy

  • Arcispedale Sant'Anna

    NOT_YET_RECRUITING

    Ferrara, FE, 44124, Italy

  • Azienda Ospedaliera - Universitaria di Parma

    RECRUITING

    Parma, PR, 43126, Italy

  • Azienda Ospedaliera San Camillo Forlanini

    ACTIVE_NOT_RECRUITING

    Roma, RM, 00152, Italy

  • Azienda Ospedaliera Universitaria Integrata Verona

    NOT_YET_RECRUITING

    Verona, VR, 37126, Italy

  • Azienda Ospedaliera di Perugia

    ACTIVE_NOT_RECRUITING

    Perugia, PG, 06129, Italy

  • Azienda Ospedaliero - Universitaria di Modena

    ACTIVE_NOT_RECRUITING

    Modena, MO, 41125, Italy

  • Azienda Ospedaliero - Universitaria di Reggio Emilia

    ACTIVE_NOT_RECRUITING

    Reggio Emilia, RE, 42122, Italy

  • Azienda Sanitaria Toscana Nord - Ovest

    ACTIVE_NOT_RECRUITING

    Lucca, LU, 55100, Italy

  • Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)

    NOT_YET_RECRUITING

    Udine, UD, 33100, Italy

  • Centro di Riferimento Oncologico IRCCS di Aviano

    NOT_YET_RECRUITING

    Aviano, PN, 33081, Italy

  • Fondazione IRCCS Policlinico S. Matteo

    NOT_YET_RECRUITING

    Pavia, PV, 27100, Italy

  • IRCCS "Giovanni Paolo II"

    ACTIVE_NOT_RECRUITING

    Bari, BA, 70124, Italy

  • IRCCS Ospedale San Raffaele

    NOT_YET_RECRUITING

    Milan, MI, 20132, Italy

  • IRCCS San Gerardo dei Tintori

    NOT_YET_RECRUITING

    Monza, MB, 20900, Italy

  • Istituto Clinico Humanitas IRRCS

    NOT_YET_RECRUITING

    Rozzano, MI, 20089, Italy

  • Istituto Nazionale dei Tumori Regina Elena IRCCS - IFO

    NOT_YET_RECRUITING

    Roma, RM, 00144, Italy

  • Istituto Oncologico Veneto IRCCS

    RECRUITING

    Padova, PD, 35128, Italy

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

    NOT_YET_RECRUITING

    Meldola, FC, 47014, Italy

  • Ospedale Policlinico San Martino

    NOT_YET_RECRUITING

    Genova, GE, 16132, Italy

  • Ospedale Versilia

    ACTIVE_NOT_RECRUITING

    Lido di Camaiore, LU, 55041, Italy

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