Actively Recruiting

Age: 18Years +
All Genders
NCT07356544

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

Led by Gruppo Oncologico Italiano di Ricerca Clinica · Updated on 2026-03-05

50

Participants Needed

22

Research Sites

76 weeks

Total Duration

On this page

Sponsors

G

Gruppo Oncologico Italiano di Ricerca Clinica

Lead Sponsor

A

AstraZeneca

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, aged at least 18 years
  • Pathologically confirmed diagnosis of NSCLC from September 2024 to September 2025
  • Locally advanced (stage IIIC), not amenable to multimodal approach (chemo-radiotherapy), or metastatic (stage IV) NSCLC according to TNM VIII edition
  • Enrolled in ATLAS project
  • Presence of HER2 mutation (for Cohort 2)
  • Availability of tissue sample from the first 50 patients enrolled in Cohort 2 (for Cohort 3)
  • Written informed consent (HEROS project) must be obtained before any study-related procedure
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 22 locations

1

IRCCS "Giovanni Paolo II"

Bari, BA, Italy, 70124

Active, Not Recruiting

2

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

Meldola, FC, Italy, 47014

Not Yet Recruiting

3

Arcispedale Sant'Anna

Ferrara, FE, Italy, 44124

Not Yet Recruiting

4

Ospedale Policlinico San Martino

Genova, GE, Italy, 16132

Not Yet Recruiting

5

Ospedale Versilia

Lido di Camaiore, LU, Italy, 55041

Active, Not Recruiting

6

Azienda Sanitaria Toscana Nord - Ovest

Lucca, LU, Italy, 55100

Active, Not Recruiting

7

IRCCS San Gerardo dei Tintori

Monza, MB, Italy, 20900

Not Yet Recruiting

8

IRCCS Ospedale San Raffaele

Milan, MI, Italy, 20132

Not Yet Recruiting

9

ASST Grande Ospedale Metropolitano Niguarda

Milan, MI, Italy, 20162

Not Yet Recruiting

10

Istituto Clinico Humanitas IRRCS

Rozzano, MI, Italy, 20089

Not Yet Recruiting

11

Azienda Ospedaliero - Universitaria di Modena

Modena, MO, Italy, 41125

Active, Not Recruiting

12

Istituto Oncologico Veneto IRCCS

Padova, PD, Italy, 35128

Actively Recruiting

13

Azienda Ospedaliera di Perugia

Perugia, PG, Italy, 06129

Active, Not Recruiting

14

Centro di Riferimento Oncologico IRCCS di Aviano

Aviano, PN, Italy, 33081

Not Yet Recruiting

15

Azienda Ospedaliera - Universitaria di Parma

Parma, PR, Italy, 43126

Actively Recruiting

16

Fondazione IRCCS Policlinico S. Matteo

Pavia, PV, Italy, 27100

Not Yet Recruiting

17

Azienda Ospedaliero - Universitaria di Reggio Emilia

Reggio Emilia, RE, Italy, 42122

Active, Not Recruiting

18

Istituto Nazionale dei Tumori Regina Elena IRCCS - IFO

Roma, RM, Italy, 00144

Not Yet Recruiting

19

Azienda Ospedaliera San Camillo Forlanini

Roma, RM, Italy, 00152

Active, Not Recruiting

20

AOU San Luigi Orbassano

Orbassano, TO, Italy, 10043

Not Yet Recruiting

21

Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)

Udine, UD, Italy, 33100

Not Yet Recruiting

22

Azienda Ospedaliera Universitaria Integrata Verona

Verona, VR, Italy, 37126

Not Yet Recruiting

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Research Team

M

Marcello Tiseo, MD, PhD

CONTACT

A

Alessandro Leonetti, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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