NCT07356544 Observational, Prospective, Multi-centric Study Exploring HER2 Mutations Incidence and Therapeutic Management in aNSCLC
| NCT ID | NCT07356544 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Gruppo Oncologico Italiano di Ricerca Clinica |
| Condition | NSCLC (Advanced Non-small Cell Lung Cancer) |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-08-12 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2025-08-12 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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: \-
Contact & Investigator
Marcello Tiseo, MD, PhD
STUDY DIRECTOR
Gruppo Oncologico Italiano di Ricerca Clinica
Frequently Asked Questions
Who can join the NCT07356544 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying NSCLC (Advanced Non-small Cell Lung Cancer). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07356544 currently recruiting?
Yes, NCT07356544 is actively recruiting participants. Contact the research team at goirc-heros@goirc.org for enrollment information.
Where is the NCT07356544 trial being conducted?
This trial is being conducted at Bari, Italy, Meldola, Italy, Ferrara, Italy, Genova, Italy and 11 additional locations.
Who is sponsoring the NCT07356544 clinical trial?
NCT07356544 is sponsored by Gruppo Oncologico Italiano di Ricerca Clinica. The principal investigator is Marcello Tiseo, MD, PhD at Gruppo Oncologico Italiano di Ricerca Clinica. The trial plans to enroll 50 participants.
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