NCT07356544

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
9mo left

Started Aug 2025

Geographic Reach
1 country

22 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Aug 2025Jan 2027

First Submitted

Initial submission to the registry

January 14, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

August 12, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

January 14, 2025

Last Update Submit

March 4, 2026

Conditions

HER2NSCLC (Advanced Non-small Cell Lung Cancer)

Keywords

HER2 mutated

Outcome Measures

Primary Outcomes (1)

  • Prevalence of HER2 mutation

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

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

IRCCS "Giovanni Paolo II"

Bari, BA, 70124, Italy

ACTIVE NOT RECRUITING

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

Meldola, FC, 47014, Italy

NOT YET RECRUITING

Arcispedale Sant'Anna

Ferrara, FE, 44124, Italy

NOT YET RECRUITING

Ospedale Policlinico San Martino

Genova, GE, 16132, Italy

NOT YET RECRUITING

Ospedale Versilia

Lido di Camaiore, LU, 55041, Italy

ACTIVE NOT RECRUITING

Azienda Sanitaria Toscana Nord - Ovest

Lucca, LU, 55100, Italy

ACTIVE NOT RECRUITING

IRCCS San Gerardo dei Tintori

Monza, MB, 20900, Italy

NOT YET RECRUITING

IRCCS Ospedale San Raffaele

Milan, MI, 20132, Italy

NOT YET RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, MI, 20162, Italy

NOT YET RECRUITING

Istituto Clinico Humanitas IRRCS

Rozzano, MI, 20089, Italy

NOT YET RECRUITING

Azienda Ospedaliero - Universitaria di Modena

Modena, MO, 41125, Italy

ACTIVE NOT RECRUITING

Istituto Oncologico Veneto IRCCS

Padua, PD, 35128, Italy

RECRUITING

Azienda Ospedaliera di Perugia

Perugia, PG, 06129, Italy

ACTIVE NOT RECRUITING

Centro di Riferimento Oncologico IRCCS di Aviano

Aviano, PN, 33081, Italy

NOT YET RECRUITING

Azienda Ospedaliera - Universitaria di Parma

Parma, PR, 43126, Italy

RECRUITING

Fondazione IRCCS Policlinico S. Matteo

Pavia, PV, 27100, Italy

NOT YET RECRUITING

Azienda Ospedaliero - Universitaria di Reggio Emilia

Reggio Emilia, RE, 42122, Italy

ACTIVE NOT RECRUITING

Istituto Nazionale dei Tumori Regina Elena IRCCS - IFO

Roma, RM, 00144, Italy

NOT YET RECRUITING

Azienda Ospedaliera San Camillo Forlanini

Roma, RM, 00152, Italy

ACTIVE NOT RECRUITING

AOU San Luigi Orbassano

Orbassano, TO, 10043, Italy

NOT YET RECRUITING

Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)

Udine, UD, 33100, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Integrata Verona

Verona, VR, 37126, Italy

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

FFPE material and blood

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Marcello Tiseo, MD, PhD

    Gruppo Oncologico Italiano di Ricerca Clinica

    STUDY DIRECTOR

Central Study Contacts

Marcello Tiseo, MD, PhD

CONTACT

+390521704465goirc-heros@goirc.org

Alessandro Leonetti, MD, PhD

CONTACT

info@goirc.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2025

First Posted

January 21, 2026

Study Start

August 12, 2025

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Last Updated

March 5, 2026

Record last verified: 2026-03

Locations

IT(22)