In Vitro NSCLC EGFR-Mutant Models for Drug Sensitivity Testing
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients who have not provided written informed consent will be excluded from the study.
Trial population
Adult patients with non-small cell lung cancer (NSCLC) harboring EGFR mutations, undergoing diagnostic or therapeutic procedures as part of routine clinical practice, with available residual biological material.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Generate in vitro cellular models derived from tumors of patients with NSCLC carrying EGFR mutations, using residual biological samples, to be used for evaluating sensitivity to anti-EGFR drugs.
The primary objective is to generate in vitro cellular models derived from tumors of patients with non-small cell lung cancer (NSCLC) harboring EGFR mutations, using residual biological samples, to be used for evaluating sensitivity to anti-EGFR drugs.
Time frame
Throughout the study, 3 yearsSecondary outcomes
1
Degree of molecular concordance between the original tumor and derived models
Compare the molecular characteristics of the obtained models with those of the original tumor in order to verify their biological concordance.
Time frame
Throughout the study, 3 years2
Variation in cell viability in in vitro models following treatment with anti-EGFR drugs
To explore, in an exploratory manner, the in vitro response to anti-EGFR drugs in relation to the type of EGFR mutation.
Time frame
Throughout the study, 3 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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