Predictive Gene Profiles and Dynamic Measurement of Treatment Response in Metastatic Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Predictive gene profiles
研究概览
简要总结
The study aims include:
- Exploring potential predictive molecular profiles to immunotherapy/chemotherapy
- Investigating the role of circulating tumor DNA as a dynamic biomarker during immunotherapy/chemotherapy
- Identifying possible resistance mechanisms to immunotherapy/chemotherapy
Materials and methods:
Approximately 150 patients diagnosed with metastatic NSCLC assigned for immunotherapy or chemotherapy will be candidates for inclusion during a 1-2 years period.
A comprehensive molecular profiling will be made from the diagnostic biopsy. Before every treatment-cycle a blood sample will be taken to quantify ctDNA. At time of progressive disease during/after first line treatment, patients will be asked to participate in a new biopsy and a comprehensive molecular profiling will be performed.
The tissue and blood samples collected will be stored in a biobank. Clinical data will be collected to perform a comprehensive database.
Analysis:
Potentially predictive molecular profiles for immunotherapy/chemotherapy will be found by comparison of treatment outcome for patients with specific molecular characteristics.
Through quantification of ctDNA during treatment and upon progression, the role of ctDNA as a dynamic biomarker will be further strengthened.
Differences in molecular profiles pre- and post-treatment may reveal resistance mechanisms to treatment. Molecular profiling on progression can be valuable in second-line treatment guidance.
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
- •Able to understand and read Danish
- •WHO Performance status 0-2
- •Acceptable organ function (liver/kidney/heart) for treatment
- •The disease has to be:
- •evaluable or measurable according to RECIST/iRECIST accessible for biopsy metastatic or not suitable for curative intended treatment
排除标准
- •Other active cancers
- •Contraindications for systemic therapy
- •ALK-positive, ROS-1 or EGFR mutations
结局指标
主要结局
Predictive gene profiles
时间窗: until progression or death, an average of 3 years
Concordance between specific gene profiles and treatment outcomes
Resistance mechanisms toward chemotherapy and immunotherapy
时间窗: until progression or death, an average of 3 years
Differences in molecular profiles pre- and post-treatment
ctDNA as a dynamic biomarker
时间窗: until progression or death, an average of 3 years
Quantification of ctDNA during treatment linked to treatment outcome
次要结局
未报告次要终点