Clinical trial · Observational
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
NCT07303218CI-TRIAL-00099889HERactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| EGFR | — | UNRESOLVED | — |
| Homologous Recombination Deficiency | — | UNRESOLVED | — |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| PARP Inhibitor | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No Intervention: Observational Cohort | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Retrospective Cohort
- description
- Patients with metastatic EGFR-mutated NSCLC diagnosed and treated between January 2020 and September 2025, with tumour tissue available for HRD analysis.
- interventionNames
- Other: No Intervention: Observational Cohort
- label
- Prospective Cohort
- description
- Patients with newly diagnosed metastatic EGFR-mutated NSCLC, with baseline tumour tissue available for HRD testing and prospectively collected clinical follow-up.
- interventionNames
- Other: No Intervention: Observational Cohort
Primary outcomes (1)
- measure
- Prevalence of HRD in metastatic EGFRm NSCLC
- timeFrame
- Baseline (T0), on diagnostic tumour sample
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (26)
- BACKGROUNDDrews RM, Hernando B, Tarabichi M, Haase K, Lesluyes T, Smith PS, Morrill Gavarro L, Couturier DL, Liu L, Schneider M, Brenton JD, Van Loo P, Macintyre G, Markowetz F. A pan-cancer compendium of chromosomal instability. Nature. 2022 Jun;606(7916):976-983. doi: 10.1038/s41586-022-04789-9. Epub 2022 Jun 15. PMID 35705807
- BACKGROUNDFang S, Wang Z, Guo J, Liu J, Li C, Liu L, Shi H, Liu L, Li H, Xie C, Zhang X, Sun W, Li M. Correlation between EGFR mutation status and response to first-line platinum-based chemotherapy in patients with advanced non-small cell lung cancer. Onco Targets Ther. 2014 Jul 1;7:1185-93. doi: 10.2147/OTT.S63665. eCollection 2014. PMID 25061320
- BACKGROUNDKlinakis, A. et al. 1277P HRD status of patients with early stage non-small cell lung cancer. Annals of Oncology 34, S737-S738 (2023)
- BACKGROUNDKarachaliou N, Arrieta O, Gimenez-Capitan A, Aldeguer E, Drozdowskyj A, Chaib I, Reguart N, Garcia-Campelo R, Chen JH, Molina-Vila MA, Rosell R; Spanish Lung Cancer Group (SLCG). BRCA1 Expression and Outcome in Patients With EGFR-Mutant NSCLC Treated With Gefitinib Alone or in Combination With Olaparib. JTO Clin Res Rep. 2020 Oct 23;2(3):100113. doi: 10.1016/j.jtocrr.2020.100113. eCollection 2021 Mar. PMID 34589994
- BACKGROUNDGarcia-Campelo R, Arrieta O, Massuti B, Rodriguez-Abreu D, Granados ALO, Majem M, Vicente D, Lianes P, Bosch-Barrera J, Insa A, Domine M, Reguart N, Guirado M, Sala MA, Vazquez-Estevez S, Caro RB, Drozdowskyj A, Verdu A, Karachaliou N, Molina-Vila MA, Rosell R; Spanish Lung Cancer Group (SLCG). Combination of gefitinib and olaparib versus gefitinib alone in EGFR mutant non-small-cell lung cancer (NSCLC): A multicenter, randomized phase II study (GOAL). Lung Cancer. 2020 Dec;150:62-69. doi: 10.1016/j.lungcan.2020.09.018. Epub 2020 Oct 3. PMID 33070053
- BACKGROUNDMarcar L, Bardhan K, Gheorghiu L, Dinkelborg P, Pfaffle H, Liu Q, Wang M, Piotrowska Z, Sequist LV, Borgmann K, Settleman JE, Engelman JA, Hata AN, Willers H. Acquired Resistance of EGFR-Mutated Lung Cancer to Tyrosine Kinase Inhibitor Treatment Promotes PARP Inhibitor Sensitivity. Cell Rep. 2019 Jun 18;27(12):3422-3432.e4. doi: 10.1016/j.celrep.2019.05.058.