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

RECRUITINGSponsored by Gruppo Oncologico Italiano di Ricerca Clinica
Actively Recruiting
SponsorGruppo Oncologico Italiano di Ricerca Clinica
Started2025-08-12
Est. completion2026-01-31
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07356544

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

Age: 18 Years+Healthy volunteers accepted
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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Conditions4

CancerHER2Lung CancerNSCLC (Advanced Non-small Cell Lung Cancer)

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