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Not yet recruiting NCT07697716

In Vitro NSCLC EGFR-Mutant Models for Drug Sensitivity Testing

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Carcinoma, Non-Small-Cell Lung, EGFR Gene Mutation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • 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]
Secondary outcome measures (2)
  • Degree of molecular concordance between the original tumor and derived models [Time frame: Throughout the study, 3 years]
  • Variation in cell viability in in vitro models following treatment with anti-EGFR drugs [Time frame: Throughout the study, 3 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07697716 · 27618

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗