Targeting EGFR in Lung Cancer: Role of EGFR Mutation State and Bypass Routes in Drug Response and Resistance
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients who have not provided written informed consent will be excluded from the study.
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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)