RecruitingNCT07356544

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

HER2 in Advanced NSCLC: an Observational, Prospective, Multi-centric Study Exploring HER2 Mutations Incidence and Therapeutic Management in Italy. The HEROS Study - GOIRC-01-2022

Sponsor

Gruppo Oncologico Italiano di Ricerca Clinica

Enrollment

50 participants

Start Date

Aug 12, 2025

Study Type

OBSERVATIONAL

Conditions

HER2 NSCLC (Advanced Non-small Cell Lung Cancer)

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

Min Age: 18 Years

Inclusion Criteria11

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.

Exclusion Criteria1

Locations(22)

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

Padua, 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

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NCT07356544

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