In Vitro NSCLC EGFR-Mutant Models for Drug Sensitivity Testing

NCT07697716 | Not Yet Recruiting

• 1 other identifier: 27618
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

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.

  Throughout the study, 3 years

Secondary Outcomes (2)

• Degree of molecular concordance between the original tumor and derived models

  Throughout the study, 3 years

• Variation in cell viability in in vitro models following treatment with anti-EGFR drugs

  Throughout the study, 3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients who have not provided written informed consent will be excluded from the study.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Emlio Bria, Prof

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

EMILIO BRIA, Prof.

CONTACT

+39 0630156318; emilio.bria@policlinicogemelli.it

Ilaria Marrocco, Doc

CONTACT

ilaria.marrocco@unicatt.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 13, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 13, 2026

Record last verified: 2026-07