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NCT Number: NCT07697716

In Vitro NSCLC EGFR-Mutant Models for Drug Sensitivity Testing

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.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic EGFR Gene Mutation Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

    Time frame: 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 outcomes

  1. Degree of molecular concordance between the original tumor and derived models

    Time frame: 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.

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

EMILIO BRIA, Prof.

CONTACT

[email protected]

+39 0630156318

Ilaria Marrocco, Doc

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: PRECISE-EGFR

Important dates

Study start
2026
Primary completion
2026
Study completion
2029
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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