Real World Observational Study of Pembrolizumab for Chinese Advanced NSCLC
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 8
- 主要终点
- Rate of Adverse Drug Reaction (ADR) since start of pembrolizumab
研究概览
简要总结
This observational study is designed to assess the efficacy and safety of pembrolizumab for the treatment of Chinese advanced NSCLC.
详细描述
Pembrolizumab is a humanized antibody used in cancer immunotherapy.The NMPA(China) approved pembrolizumab for first-line treatment of certain patients with advanced NSCLC.
This is a multi-center non-interventional study, advanced NSCLC patients who treated with pembrolizumab and provide written informed consent will be included. The main objective of this study is to evaluate pembrolizumab efficacy and safety in the clinical practice and explore the prognosis-relevant factors of advanced NSCLC.
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
- •Histologically or cytologically confirmed diagnosis of advanced or metastatic NSCLC
- •Patients who receive pembrolizumab for advanced NSCLC.
- •Patients who provided written informed consent.
排除标准
- •1.Patients who would join any interventional clinical studies from first diagnosis to the end of the pembrolizumab treatment
结局指标
主要结局
Rate of Adverse Drug Reaction (ADR) since start of pembrolizumab
时间窗: up to 3 months after the last dose
Drug related AEs were evaluated using NCI-CTCAE v5.0
Median Overall survival (OS) since start of pembrolizumab
时间窗: 3 years
OS was defined as the length of time from the administration of the first-dose until death from any cause.
Objective Response Rate (ORR) since start of pembrolizumab
时间窗: 6 months
ORR was defined as the percentage of patients with complete response (CR) and partial response (PR) according to irRECIST.
次要结局
- Median Time To Treatment failure (TTF) since start of pembrolizumab(12 months)
- Median Progression Free Survival (PFS) since start of pembrolizumab(12 months)