Mechanisms of Resistance to 3rd Generation Thyrosine Kinase Inhibitors in Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Description of the molecular alterations detected in patients treated with 3rd TKI and assessment link with progression free survival and overall survival features.
研究概览
简要总结
In the management of non-small cell lung cancer of the adenocarcinoma type, different therapeutic strategies can be proposed. These strategies are defined according to the results of a biological analysis of blood and/or tissue samples from the lung tumor. Mutations in the tumor DNA are sought. Thus, patients with sensitizing mutations can benefit from a treatment with a 3rd generation tyroine kinase inhibitor (TKI) whose efficacy has been widely demonstrated. Patients without tumor mutations will not benefit. However, resistance to TKIs appears after a certain time, often linked to the appearance of new mutations in the tumor. For this reason, blood biologic analyses are regularly performed to search for the emergence of resistance mutations and to propose a therapeutic alternative as soon as possible.
These analyses are performed routinely in the laboratory. In the course of these analyses, the investigators have identified conventional mutations but also new mutations not previously described in the literature.
Our objective is to list all the molecular abnormalities revealed during blood biological analyses, to determine their frequency and to study whether certain abnormalities can be linked to resistance to TKI.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •advanced non-small cell lung cancer stage IIIB/IV
- •Documentation of activating EGFR mutations (exon 19 deletions or exon 21 L858R substitution mutations) at the time of initial diagnosis
- •Patient may receive up to one line of third EGFR TKI
- •Plasma sample testing performed to detect EGFR TKI resistance
排除标准
- •Patients have other concurrent cancers
- •Patients who are not eligible receive TKI
结局指标
主要结局
Description of the molecular alterations detected in patients treated with 3rd TKI and assessment link with progression free survival and overall survival features.
时间窗: The analysis of the TKI effectiveness and the appearance of mutations will be performed over a period of 24 months.
This retrospective study will collate the molecular alterations detected during routine analysis. The elements extracted from the file will be age, sex, type of tumor and clinical-histological characteristics, dates of diagnosis and start of treatment. In addition, information on the dates of appearance of resistances (radiographic or clinical) will also be provided. No additional analysis will be performed since the study will consist of the analysis of data generated by the analyses performed in the context of patient management and biological monitoring. This research does not aim to modify your care. There will be no additional consultation or examination, nor will there be any changes in the treatment prescribed by your doctor.
次要结局
- Frequency of detected molecular alterations(The analysis of the TKI effectiveness and the appearance of mutations will be performed over a period of 24 months.)