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

NCT07356544 · tracked via the Priya Life Science Italy tracker

Sponsor

Gruppo Oncologico Italiano di Ricerca Clinica

Phase

Observational

Started

2025-08-12

Last updated

2026-03-05

Condition(s) studied

NSCLC (Advanced Non-small Cell Lung Cancer)HER2

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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: \-

Primary outcome measure(s)

Prevalence of HER2 mutation — 1 year
Percentage of advanced NSCLC with HER2 mutations in Italy clinical practice.

Trial sites (22)

Facility	City	Region	Status
IRCCS "Giovanni Paolo II"	Bari	BA	Active Not Recruiting
Istituto Romagnolo per lo Studio dei Tumori IRST "Dino Amadori"	Meldola	FC	Not Yet Recruiting
Arcispedale Sant'Anna	Ferrara	FE	Not Yet Recruiting
Ospedale Policlinico San Martino	Genova	GE	Not Yet Recruiting
Ospedale Versilia	Lido di Camaiore	LU	Active Not Recruiting
Azienda Sanitaria Toscana Nord - Ovest	Lucca	LU	Active Not Recruiting
IRCCS San Gerardo dei Tintori	Monza	MB	Not Yet Recruiting
IRCCS Ospedale San Raffaele	Milan	MI	Not Yet Recruiting
ASST Grande Ospedale Metropolitano Niguarda	Milan	MI	Not Yet Recruiting
Istituto Clinico Humanitas IRRCS	Rozzano	MI	Not Yet Recruiting
Azienda Ospedaliero - Universitaria di Modena	Modena	MO	Active Not Recruiting
Istituto Oncologico Veneto IRCCS	Padova	PD	Recruiting
Azienda Ospedaliera di Perugia	Perugia	PG	Active Not Recruiting
Centro di Riferimento Oncologico IRCCS di Aviano	Aviano	PN	Not Yet Recruiting
Azienda Ospedaliera - Universitaria di Parma	Parma	PR	Recruiting
Fondazione IRCCS Policlinico S. Matteo	Pavia	PV	Not Yet Recruiting
Azienda Ospedaliero - Universitaria di Reggio Emilia	Reggio Emilia	RE	Active Not Recruiting
Istituto Nazionale dei Tumori Regina Elena IRCCS - IFO	Roma	RM	Not Yet Recruiting
Azienda Ospedaliera San Camillo Forlanini	Roma	RM	Active Not Recruiting
AOU San Luigi Orbassano	Orbassano	TO	Not Yet Recruiting
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)	Udine	UD	Not Yet Recruiting
Azienda Ospedaliera Universitaria Integrata Verona	Verona	VR	Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07356544 on ClinicalTrials.gov ↗ ← All trials in Italy