Non-controlled Prospective Pilot Study Assessing Prognostic Performance of Circulating Tumour DNA Kinetic Analysis for Monitoring Response to Treatment of Metastatic Non-small Cell Lung Cancers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Biological response at week 3
研究概览
简要总结
In patients with locally advanced or metastatic tumors, first-line therapeutic management is based on the use of targeted therapies (EGFR, BRAF ALK and ROS1 inhibitors), immunotherapies (anti-PD1/ anti-PDL1-antibodies or chemotherapy.
Despite patient selection based on histo-pathological and molecular criteria, not all patients respond to treatment. There are currently no markers to definitively guarantee a patient's response.
An alternative is to identify early patient response to treatment. The investigator hypothesize that change in circulating tumor DNA concentration (ctDNA) allow to early identify patients' therapeutic response (and non-response) of patients, regardless of the type of treatment used in the first line setting.
详细描述
The primary objective is to determine whether early evolution (between baseline and week 3) of circulating tumor DNA concentration predicts the radiological response to first-line treatment of advanced or metastatic NSCLC patients, regardless of treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Metastatic or locally advanced non-small cell lung cancer (stage III or IV)
- •At least one measurable target according to RECIST criteria
- •Identification of at least one molecular alteration in the tissue sample analyzed in the framework of patient management
- •Performance Status 0 to 2
- •Affiliated to a social security system
- •Patient who can be followed under the protocol
- •Patient agreed to participate in the study and gave his/her express consent
排除标准
- •Small cell or mixed bronchial cancer
- •Radiotherapy (except radiotherapy for antalgic purposes) during the last 7 days
- •Patient who has already started a first line of treatment
- •Patient already included in an interventional research protocol that may have an impact on the results of the ELUCID study
- •History of cancer (with the exception of non-melanoma skin, cervical cancer in situ, adequately treated) with sign of illness during the last 5 years
- •Patient which, does present a substantial risk of recurrence.
- •Major under guardianship, curators or deprived of liberty
- •Pregnant or lactating woman, or of childbearing age without effective contraception
- •Not affiliated to a social security system
- •Inability to understand the protocol and / or to give express consent
研究组 & 干预措施
ctDNA analysis
additional blood sample of 20 ml
干预措施: ctDNA analysis (Other)
结局指标
主要结局
Biological response at week 3
时间窗: week 3 after patient's recruitment date (baseline)
Changes of the amount of ctDNA between baseline and week 3 will make it possible to determine the biological response: increase, stability or decrease in ctDNA.
次要结局
- Biological response and progression-free survival (radiological assessment) according to the therapeutic management: targeted therapies, immunotherapy, chemotherapy(week 3 after baseline)
- Progression-free survival (radiological assessment) and biological response at week 3.(week 3 after baseline)
- biological progression and radiological progression(progression)
- biological response and radiological response(progression)