In Vitro NSCLC EGFR-Mutant Models for Drug Sensitivity Testing

Targeting EGFR in Lung Cancer: Role of EGFR Mutation State and Bypass Routes in Drug Response and Resistance

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07697716

Acronym

PRECISE-EGFR

Enrollment

Registered

2026-07-13

Start date

2026-09-01

Completion date

2029-12-31

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung, EGFR Gene Mutation

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.	Throughout the study, 3 years	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.

Secondary

Measure	Time frame	Description
Degree of molecular concordance between the original tumor and derived models	Throughout the study, 3 years	Compare the molecular characteristics of the obtained models with those of the original tumor in order to verify their biological concordance.
Variation in cell viability in in vitro models following treatment with anti-EGFR drugs	Throughout the study, 3 years	To explore, in an exploratory manner, the in vitro response to anti-EGFR drugs in relation to the type of EGFR mutation.

Contacts

CONTACTEMILIO BRIA, Prof.

emilio.bria@policlinicogemelli.it+39 0630156318

CONTACTIlaria Marrocco, Doc

ilaria.marrocco@unicatt.it

PRINCIPAL_INVESTIGATOREmlio Bria, Prof

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Outcome results