Active — Not RecruitingNot Applicable

The HER Project: HRD in EGFR-mutated NSCLC

Italy100 participantsStarted 2025-12-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. Insufficient baseline tumour tissue (unsuitable for HRD scoring)
✕. Presence of EGFR uncommon mutations (i.e. ex20ins)
✕. Known presence of co-occurring uncommon EGFRm, ALK, ROS1, or other main oncogenic drivers.

What they're measuring

Prevalence of HRD in metastatic EGFRm NSCLC

Timeframe: Baseline (T0), on diagnostic tumour sample

Trial details

NCT IDNCT07303218

SponsorIRCCS San Raffaele

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2029-12-31

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