Observational, Prospective, Multi-centric Study Exploring HER2 Mutations Incidence and Therapeutic Management in aNSCLC
Recruiting · NCT07356544 · Observational (researchers observe without assigning treatment) · Lead sponsor: Gruppo Oncologico Italiano di Ricerca Clinica
View the official record on ClinicalTrials.gov →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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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.
Where it is running
22 locations listed.
- IRCCS "Giovanni Paolo II" - Bari, BA, Italy
- Istituto Romagnolo per lo Studio dei Tumori IRST "Dino Amadori" - Meldola, FC, Italy
- Arcispedale Sant'Anna - Ferrara, FE, Italy
- Ospedale Policlinico San Martino - Genova, GE, Italy
- Ospedale Versilia - Lido di Camaiore, LU, Italy
- Azienda Sanitaria Toscana Nord - Ovest - Lucca, LU, Italy
- IRCCS San Gerardo dei Tintori - Monza, MB, Italy
- IRCCS Ospedale San Raffaele - Milan, MI, Italy
- ASST Grande Ospedale Metropolitano Niguarda - Milan, MI, Italy
- Istituto Clinico Humanitas IRRCS - Rozzano, MI, Italy
- Azienda Ospedaliero - Universitaria di Modena - Modena, MO, Italy
- Istituto Oncologico Veneto IRCCS - Padova, PD, Italy
- Azienda Ospedaliera di Perugia - Perugia, PG, Italy
- Centro di Riferimento Oncologico IRCCS di Aviano - Aviano, PN, Italy
- Azienda Ospedaliera - Universitaria di Parma - Parma, PR, Italy
- Fondazione IRCCS Policlinico S. Matteo - Pavia, PV, Italy
- Azienda Ospedaliero - Universitaria di Reggio Emilia - Reggio Emilia, RE, Italy
- Istituto Nazionale dei Tumori Regina Elena IRCCS - IFO - Roma, RM, Italy
- Azienda Ospedaliera San Camillo Forlanini - Roma, RM, Italy
- AOU San Luigi Orbassano - Orbassano, TO, Italy
- Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - Udine, UD, Italy
- Azienda Ospedaliera Universitaria Integrata Verona - Verona, VR, Italy