Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2 | — | UNRESOLVED | — |
| NSCLC (Advanced Non-small Cell Lung Cancer) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Prevalence of HER2 mutation
- timeFrame
- 1 year
- description
- Percentage of advanced NSCLC with HER2 mutations in Italy clinical practice.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: \-
References
Publications (0)
Data not yet available