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

RecruitingN/A

Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica

Conditions: NSCLC (Advanced Non-small Cell Lung Cancer), HER2

Countries: Italy

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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:

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Locations (22)

Bari, BA, Italy
Meldola, FC, Italy
Ferrara, FE, Italy
Genova, GE, Italy
Lido di Camaiore, LU, Italy
Lucca, LU, Italy
Monza, MB, Italy
Milan, MI, Italy
Milan, MI, Italy
Rozzano, MI, Italy
Modena, MO, Italy
Padova, PD, Italy
Perugia, PG, Italy
Aviano, PN, Italy
Parma, PR, Italy
Pavia, PV, Italy
Reggio Emilia, RE, Italy
Roma, RM, Italy
Roma, RM, Italy
Orbassano, TO, Italy
Udine, UD, Italy
Verona, VR, Italy