REAL-WORLD TREATMENT PATTERNS AND CLINICAL EFFECTIVENESS OF DACOMITINIB IN ADVANCED NON-SMALL CELL LUNG CANCER PATIENTS WITH EPIDERMAL GROWTH FACTOR RECEPTOR-POSITIVE IN TAIWAN
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Percentage of patients with dacomitinib treatment discontinuation
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.
This study is seeking participants who:
- have lung cancer that could not be controlled.
- 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 received dacomitinib for their lung cancer.
All participants in this study had received dacomitinib. Dacomitinib is a tablet that is taken by mouth at home. They continued to take dacomitnib until their cancer was 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
- Retrospective
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
- •Evidence of histologically or cytologically confirmed diagnosis of advanced NSCLC with EGFR-activating mutations detected by an appropriate test
- •Patients who were treated with dacomitinib as first-line treatment for advanced NSCLC during 01 October 2020 to 31 December
- •Age ≥18 years old
- •Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
排除标准
- •Patients who have been treated with any systemic anti-cancer therapies within 12 months prior to dacomitinib treatment.
结局指标
主要结局
Percentage of patients with dacomitinib treatment discontinuation
时间窗: 52 months from index date
The percentage of patients with dacomitinib treatment discontinuation for any reason during follow-up period will be summarized.
Percentage of patients with dacomitinib dosage change and reasons
时间窗: 52 months from index date
The percentage of patients with dacomitinib dosage change and reason during follow-up period will be summarized.
次要结局
- Real-world overall survival (rwOS)(52 months from index date)
- Real-world best objective response rate (rwORR)(52 months from index date)
- Real-world progression-free survival(52 month from index date)
- real-world intracranial response rate (rwIC-ORR)(52 months from index date)
- real-world extracranial response rate (rwEC-ORR)(52 months from index date)