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NCT07697716
In Vitro NSCLC EGFR-Mutant Models for Drug Sensitivity Testing
Conditions: Carcinoma, Non-Small-Cell Lung, EGFR Gene Mutation
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 30
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Summary
The PRECISE-EGFR study is a prospective, observational project designed to generate patient-derived in vitro models (cell cultures and organoids) from individuals with non-small cell lung cancer (NSCLC) carrying EGFR mutations. These models will be used to evaluate sensitivity to different anti-EGFR therapies and explore mechanisms of drug resistance.
Using residual biological samples collected during routine clinical practice, the study will not interfere with patient care. Researchers will also compare the molecular characteristics of the models with the original tumors to ensure reliability.
The overall aim is to improve precision oncology approaches, identifying the most effective treatments for specific EGFR mutation subtypes while minimizing toxicity and resistance.
Eligibility Criteria
Inclusion Criteria:
* Age ≥ 18 years.
* Diagnosis of non-small cell lung cancer (NSCLC), regardless of the line of treatment.
* Documented presence of an EGFR mutation.
* Availability of residual biological material obtained from diagnostic or therapeutic procedures performed as part of routine clinical practice.
* Signed written informed consent for study participation.
Exclusion Criteria:
* Patients who have not provided written informed consent will be excluded from the study.
Source: ClinicalTrials.gov (NCT07697716). StuddyBuddy aggregates publicly available trial information.