A Multicenter, Observational Study to Describe the Effectiveness and Treatment Patterns of Dacomitinib Among Epidermal Growth Factor Receptor Mutation-Positive Non-Small Cell Lung Cancer Patients With Brain Metastasis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Pfizer
- 入组人数
- 100
- 主要终点
- The real-world intracranial overall response rate (rwICORR) at Month 3
研究概览
简要总结
The purpose of this study is to learn about dacomitinib for the possible treatment of lung cancer which has spread to other parts of the body.
This study is seeking participants who:
- have lung cancer that has reached at least the brain.
- have a type of gene called epidermoid growth factor receptor. A gene is a part of your DNA that has instructions for making things your body needs to work.
- have not received any treatment before.
All participants in this study will receive dacomitnib 1 time a day. Dacomitinib is a tablet that is taken by mouth at home. They can continue to take dacomitnib until their cancer is no longer responding. The study will look at the experiences of people receiving the study medicine. This will help to see if the study medicine is safe and effective.
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
- •at least 18 years old
- •confirmed diagnosis of EGFR mutation-positive NSCLC
- •at least one measurable intracranial metastasis
- •ECOG-PS of 0, 1 or 2
- •dacomitinib as first-line treatment for advanced NSCLC
- •Evidence of a personally signed and dated informed consent document (ICD)
排除标准
- •any anti-cancer systemic treatment within 12 months prior to index date
- •currently on active investigational drug(s) treatment in other clinical studies (Phase 1-4) within 2 weeks before the current study begins and/or during study participation.
研究组 & 干预措施
dacomitnib
干预措施: dacomitnib (Drug)
结局指标
主要结局
The real-world intracranial overall response rate (rwICORR) at Month 3
时间窗: 3 months from first dose of dcomitnib
The percentage of patients achieving real-world intracranial overall response (complete response (CR) or partial response (PR)) for brain metastases at Month 3 (± 4 weeks) will be summarized.
The real-world intracranial overall response rate (rwICORR) at Month 6
时间窗: 6 months from first dose of dacomitnib
The percentage of patients achieving real-world intracranial overall response (CR or PR) for brain metastases at Month 6 (± 4 weeks) will be summarized.
The real-world systemic overall response rate (rwORR) at Month 6.
时间窗: 6 months from first dose of dacomitinib
The number and percentage of patients achieving real-world systemic overall response (CR or PR) for brain metastases at Month 6 (± 4 weeks) will be summarized.
The real-world intracranial clinical benefit rate (rwICBR) at Month 3
时间窗: 3 months from first dose of dacomitinib
The percentage of patients with real-world intracranial clinical benefit (CR, PR or SD) for brain metastases at Month 3 (± 4 weeks) will be summarized
The real-world intracranial clinical benefit rate (rwICBR) at Month 6
时间窗: 6 months from first dose of dacomitinib
The percentage of patients with real-world intracranial clinical benefit (CR, PR or SD) for brain metastases at Month 6 (± 4 weeks) will be summarized
The real-world intracranial clinical benefit rate (rwICBR) at Month 12
时间窗: 12 months from first dose of dacomitinib
The percentage of patients with real-world intracranial clinical benefit (CR, PR or SD) for brain metastases at Month 12 (± 4 weeks) will be summarized
The real-world intracranial time to progression (rwICTTP)
时间窗: 30 months from first dose of dacomitinib
The mean and median of the time to the date of the first documentation of real-world progression of intracranial disease.
The real-world systemic overall response rate (rwORR) at Month 3
时间窗: 3 months from first dose of dacomitinib
The number and percentage of patients achieving real-world systemic overall response (CR or PR) for brain metastases at Month 3 (± 4 weeks) will be summarized.
The real-world intracranial overall response rate (rwICORR) at Month 12
时间窗: 12 months from first dose of dacomitinib
The percentage of patients achieving real-world intracranial overall response (CR or PR) for brain metastases at Month 12 (± 4 weeks) will be summarized.
The real-world systemic overall response rate (rwORR) at Month 12.
时间窗: 12 months from first dose of dacomitinib
The number and percentage of patients achieving real-world systemic overall response (CR or PR) for brain metastases at Month 12 (± 4 weeks) will be summarized.
The real-world progression-free survival (rwPFS) during 12 months from index date
时间窗: 12 months from index date
Time to real-world disease progression or death, whichever occurs first, during 12 months from index date will be summarized by the K-M plot with the corresponding 95% CI.
The real-world overall survival (rwOS) during 12 months from index date
时间窗: 12 months from index date
Time to real-world death during 12 months from index date will be summarized by the K-M plot with the corresponding 95% CI.
The real-world overall survival (rwOS) during 24 months from index date
时间窗: 24 months from index date
Time to real-world death during 24 months from index date will be summarized by the K-M plot with the corresponding 95% CI.
次要结局
- Percentage of patients with dacomitinib treatment discontinuation(30 months from first dose of dacomitinib)
- Time to dacomitinib treatment discontinuation(30 months from first dose of dacomitinib)
- Number of patients with dacomitinib dosage change and reasons(30 months from first dose of dacomitinib)
- Time to dacomitinib dosage change(30 months from first dose of dacomitinib)
- Concomitant NSCLC-related treatment(30 months from first dose of dacomitinib)