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Clinical Trials in Italy / NCT07303218
Active, not recruiting Observational

The HER Project: HRD in EGFR-mutated NSCLC

NCT07303218 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS San Raffaele
Phase
Observational
Started
2025-12-01
Last updated
2025-12-31

Condition(s) studied

EGFRNon Small Cell Lung CancerHomologous Recombination DeficiencyPARP Inhibitor

Investigational drug(s) / intervention(s)

No Intervention: Observational Cohort

No Intervention: Observational Cohort: Observational study only; participants receive standard-of-care treatments not assigned by the study

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. 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. 2. Age ≥18 years old 3. Have a metastatic histologically confirmed NSCLC 4. Presence of EGFR common mutations (i.e. ex19del and L858R) 5. Have sufficient biological material to assess genomic profiling with AmoyDx Focus panel or similar 6. Clinical data available Exclusion Criteria: 1. Insufficient baseline tumour tissue (unsuitable for HRD scoring) 2. Presence of EGFR uncommon mutations (i.e. ex20ins) 3. Known presence of co-occurring uncommon EGFRm, ALK, ROS1, or other main oncogenic drivers.

Primary outcome measure(s)

  • Prevalence of HRD in metastatic EGFRm NSCLC — Baseline (T0), on diagnostic tumour sample
    Proportion of EGFRm NSCLC with an HRD positive score evaluated by AmoyDx HRD Panel or similar (GSS ≥ 50).

Trial sites (1)

FacilityCityRegionStatus
Dept. Medical Oncology Milan MI

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Other trials for the same condition

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Vapor Ablation for Localized Cancer Lesions Starting soon
A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer. Recruiting
Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC Active, not recruiting
Overcoming Resistance to EGFR Neutralization by Combination of Monoclonal Antibodies and Novel Cancer Drugs Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07303218 on ClinicalTrials.gov ↗ ← All trials in Italy