NCT07303218Active, not recruiting
The HER Project: HRD in EGFR-mutated NSCLC
The HER Project: Homologous Recombination Deficiency in EGFR-Mutated NSCLC, a Retrospective and Prospective Translational Single-center Study
Source: ClinicalTrials.gov · Last updated 31 Dec 2025
Brief summary (registry, in English)
This observational retrospective-prospective study aims to evaluate the prevalence of homologous recombination deficiency (HRD) in metastatic EGFR mutated NSCLC and to assess its correlation with clinical and molecular features. Based on the hypothesis that HRD identifies a distinct EGFRm subgroup with prognostic value and a potential sensitivity to PARP inhibitor-based strategies, translational analysis will be performed with multiple pre-clinical models, ranging from human cancer cells to murine models.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 11 Dec 2025
- Start date
- 1 Dec 2025
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- IRCCS San Raffaele
- Diseases
- Lung cancer
- NCT number
- NCT07303218
What you commit to
- Study type: Observational
- Planned participants: 100
- From 1 Dec 2025 to the primary completion date, 31 Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Presence of EGFR uncommon mutations (i.e. ex20ins)
Other
- Insufficient baseline tumour tissue (unsuitable for HRD scoring)
- Known presence of co-occurring uncommon EGFRm, ALK, ROS1, or other main oncogenic drivers.
Who the study is looking for
- Participant is willing and able to give informed consent for participation in the study. However, since a part of the study is retrospective and, considering the large sample sizes required and considering that the disease involved in this study affects elderly subjects with co-morbidities and presents a significant mortality rate based on the stage of the disease, deceased and untraceable patients will also be included.
- Age ≥18 years old
- Have a metastatic histologically confirmed NSCLC
- Presence of EGFR common mutations (i.e. ex19del and L858R)
- Have sufficient biological material to assess genomic profiling with AmoyDx Focus panel or similar
- Clinical data available
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dept. Medical Oncology Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.