Programmed Death-ligand 1(PD-L1) and Other Immuno-markers Influenced by Osimertinib Treatment in Advanced Non-small Cell Lung Cancer (NSCLC) Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 155
- 试验地点
- 12
- 主要终点
- Measure PD-L1 value
研究概览
简要总结
The study will investigate whether PD-L1 and other immuno-markers will be influenced by osimertinib treatment in advanced epidermal growth factor receptor （EGFR）T790M positive advanced NSCLC patients. In addition, we will explore whether PD-L1 and other immuno-markers can predict the safety and efficacy of subsequent use of immune checkpoint inhibitors at the time of PD due to osimertinib resistance.
详细描述
Investigate whether PD-L1 and other immuno-markers will be influenced by osimertinib treatment in advanced EGFR T790M positive advanced NSCLC patients.
explore whether PD-L1 and other immuno-markers can predict the safety and efficacy of subsequent use of immune checkpoint inhibitors at the time of PD due to osimertinib resistance.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
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
- •The patient enrolled in ASTRIS or patient who are eligible for the ASTRIS study.
- •The patient is willing to provide informed consent form to provide specimen before osimertinib treatment and at the time of PD.
- •Patients must be able to undergo a fresh tumor biopsy during screening or to provide an available tumor sample taken <2 months prior to screening.
- •Fine needle aspirate specimens are not acceptable.
- •Specimens from metastatic bone lesions are typically unacceptable unless there is confirmed soft tissue component.
- •The tumor specimen submitted to establish eligibility should be of sufficient quantity to allow for PD-L1 IHC and other biomarker analyses (if applicable) and is preferred in formalin-fixed paraffin embedded blocks.
排除标准
- •The patient does not have sufficient tumor tissue specimen available for detection.
- •The Patient who is unwilling to use the existing data from medical practice for scientific research.
- •The patient who received immunotherapy therapy before.
结局指标
主要结局
Measure PD-L1 value
时间窗: baseline and PD，up to 24 months
Measure PD-L1 value Change by tumor cells（TC）/immune cells(IC) staining from the baseline to progressive disease（PD）
Measure PD-L1 expression positive rate (%)
时间窗: baseline and PD，up to 24 months
Measure PD-L1 expression positive rate (%) change from the baseline to progressive disease（PD）
次要结局
未报告次要终点