Feasibility of New Biological and Histological Samples at Progression for Patients With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 18
- 主要终点
- Feasibility of re-biopsies
研究概览
简要总结
Feasibility of new biological and histological samples at progression in patients with advanced or metastatic Non Small Cell Lung Cancer (NSCLC).
A recent paper from Professor Sequist and coll. has depicted the resistance mechanisms as Thréonine790Methionine (T890M) mutation oncogene cMet (CMet) amplification. Re-biopsies showed in 14% of cases the transition between NSCLC to Small Cells Lung Cancer (SCLC). In 3 patients, resistance mechanisms have disappeared and they became again sensitive to Tyrosine Kinase Inhibitors (TKIs). It is mandatory to have a better description to natural history of the disease. This study will be conducted by the French Group of Pneumology-Oncology (Groupe Français de Pneumo Cancérologie (GFPC)) up to 100 patients during 18 Months. Each center will have to define if re-biopsies are possible or not and explain why not.
详细描述
ABSTRACT PROMOTOR GFPC
MAIN INVESTIGATORS Pr Vergnenegre Alain, Dr Dujon Cécile, Pr Rosell Rafael TITLE Feasibility of new biological and histological samples at progression in patients with advanced or metastatic Non Small Cell Lung Cancer (NSCLC)
JUSTIFICATION / BACKGROUND In NSCLC, recent progresses have been reached, with better outcome in terms of survival without relapse, response rate, and improvement of Qualify of Life (QoL). In the detail, patients with mutations of Epidermal Growth Factor Receptor (EGF-R) are sensitive to tyrosine kinase inhibitors (TKIs).
- Patients with EGF-R mutation Response and disease control are frequently achieved on some long period of time but, in the majority of cases, resistances appear around a period of 12 months after the diagnosis. One of the major resistance mechanisms is the onset of T790M mutation, which induces a non sensitivity to TKIs. At the opposite, some recent papers have depicted that, after a free interval, resistant tumor can be responder in a second phase to TKIs]. The type of the mutation has different consequences on the disease evolution. A recent paper from Pr. Sequist and coll. has depicted the resistance mechanisms as mutation T790M or oncogene cMet (CMet) amplification. Re-biopsies showed in 14% of cases the transition between NSCLC to SCLC. In 3 patients, resistance mechanisms have disappeared and they became again sensitive to TKIs. It is mandatory to have a better description to natural history of the disease.
- Patients without EGF-R mutation The knowledge of genetic characteristics is currently needed to perform an inclusion in some research protocol.
TRIAL DESIGN Translational study with iterative biopsies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •All the patient more than 18 years old with advanced or metastatic NSCLC in progression after one or more treatment by chemotherapy.
排除标准
- •SCLC, neuroendocrine carcinoma,
- •Patients with judicial protection or deprived of liberty
结局指标
主要结局
Feasibility of re-biopsies
时间窗: 18 months / 100 patients
Feasibility of re-biopsies in patients with advanced or metastatic NSCLC after progression of disease under treatment. If the re-biopsy could not be performed : reason of no re-biopsy. If the biopsy could be performed : site and method of rebiopsy.
次要结局
- Disease management(18 months / 100 patients)
- Type of resistance(18 months/100 patients)
- Biological history of the disease(18 months / 100 patients)