Real World Evidence of Long-term Safety and Efficacy in Patients Treated With Durvalumab After Concurrent Chemoradiation for Unresectable Stage III NSCLC.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 529
- 试验地点
- 1
- 主要终点
- Incidence of pneumonitis and AESI
研究概览
简要总结
This observational study is designed to assess the long term safety of the durvalumab treatment period including subsequent treatment period and demonstrate the efficacy of patients treated with durvalumab following chemoradiation therapy in the real world.
详细描述
Study design: Prospective multi-center non-interventional cohort study Data Source(s): Medical records of patients who are treated with durvalumab following chemoradiation therapy Study Population: Patients prescribed and treated with durvalumab for unresectable stage III non-small cell lung cancer (NSCLC) at first time following chemoradiation therapy and who provide written informed consent.
Exposure(s): durvalumab Outcome(s): Summary of pneumonitis and adverse event special interest (AESI), progression free survaival (PFS), overall survaival (OS), Reasons of discontinuation of durvalumab treatment, Details of subsequent treatments after durvalumab Sample Size Estimations: 500 patients Statistical Analysis: Only descriptive analysis and no formal test
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who receive durvalumab for unresectable stage III NSCLC at first time following chemoradiation therapy.
- •Patients who provided written informed consent.
排除标准
- •Patients who would join Post Marketing Surveyllance for durvalumab.
- •Patients who would join any interventional clinical studies using unapproved drugs or off-label use of drugs from first diagnosis to the end of the durvalumab treatment
- •Age < 20
结局指标
主要结局
Incidence of pneumonitis and AESI
时间窗: 3 years
Pneumonitis and AESIs will be summarized at least following categories * Pneumonitis within three years from the start of durvalmab treatment * Pneumonitis and AESIs during treatment period of durvalmab * Pneumonitis and AESIs after durvalmab treatment
To assess progression free survival (PFS) of durvalumab
时间窗: PFS is assessed as PFS median for time of 3 years
PFS is defined as the time from the start of durvalumab treatment to first progression disease (PD) or death, whichever is earlier. In case the patients without progression or death, patients will be censored at the last follow-up date or the first date of the 1st subsequent treatment, whichever is earlier.
次要结局
- To assess overall survaival (OS) of durvalumab(OS is assessed as median OS for time of 3 years)
- Incidence of pneumonitis and AESIs in patient subset populations(3 years)