Post-Marketing Surveillance (Usage Results Study) of Brigatinib in the Treatment of Adult Patients for Approved Indications in South Korea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 271
- 试验地点
- 1
- 主要终点
- Percentage of Participants with AEs and SAEs
研究概览
简要总结
The purpose of this study is to estimate the proportion of all adverse events (AEs) including serious adverse events (SAEs) occurring with the use of brigatinib among adult participants who have been administered brigatinib as per the approved indications.
详细描述
This is a prospective observational post-marketing surveillance study of participants with ALK-positive NSCLC who initiate treatment for the first time with brigatinib in a routine clinical practical setting. The study will characterize the safety and effectiveness of brigatinib for its approved indications under real world use.
The study will enroll approximately 257 participants. The data will be prospectively collected, at the centers from routinely scheduled and emergency visits until end of follow up, and recorded into electronic case report forms (e-CRFs). All participants will be assigned to a single observational cohort.
This multi-center study will be conducted in the South Korea. The overall duration of this study is approximately 6 years. Data will be collected over and up to a 24 month-surveillance period (per participant) once enrolled.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With ALK-positive advanced or metastatic NSCLC.
- •Who initiate brigatinib for the first time.
排除标准
- •Treated with brigatinib outside of the locally approved label in Korea.
- •Whom brigatinib is contraindicated as per product label.
- •Participating in other clinical trials of NSCLC treatment.
结局指标
主要结局
Percentage of Participants with AEs and SAEs
时间窗: Up to 30 days after the end of treatment (up to 24 months)
次要结局
- Progression Free Survival (PFS)(From first administration of study drug to the date of disease progression or death due to any cause (up to 24 months))
- Duration of Response (DOR)(Up to 24 months)
- Objective Response Rate (ORR)(Up to 24 months)