Post Authorization Study to Monitor Efficacy, Effectiveness and Safety of Brigatinib (Alunbrig®) in Anaplastic Lymphoma Kinase (ALK) Positive Metastatic Non Small Cell Lung Cancer (NSCLC) in Argentina
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Number of Participants Reporting One or More Non-serious Adverse Events (Non-SAEs)
研究概览
简要总结
The aims of the study are to assess the safety profile of brigatinib and the clinical response rates in adults with Anaplastic Lymphoma Kinase (ALK)-Positive Metastatic Non Small Cell Lung Cancer (NSCLC). Treatment with brigatinib and follow-up will be according to routine clinical practice.
Study doctors will review the participants' medical records at the start of the study, then at 12 and 24 weeks after treatment starts.
详细描述
This is a prospective, observational post-marketing surveillance study of brigatinib in participants with advanced or metastatic NSCLC. This study will assess the safety, efficacy and effectiveness of brigatinib for its approved indications in a routine clinical practice setting under real world use.
The study will enroll approximately 37 participants. The data will be collected both prospectively and/or retrospectively at the specialized centers and outpatient oncology clinics and will be recorded by the investigator in the electronic Case Report Form (eCRF) based on the routine medical care data that is collected in the medical records. All the participants will be assigned to a single observational cohort:
• All Participants
This multi-center study will be conducted in Argentina. The overall duration of the study will be approximately 52 weeks. Data collection will be based on routine visit after every 12 weeks from the start of treatment up to 24 weeks of follow up or death or cancer progression or treatment discontinuation, whichever occurs first.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •With either a diagnosis of ALK positive metastatic NSCLC previously treated with crizotinib OR a diagnosis of ALK positive metastatic NSCLC previously not treated with an ALK inhibitor. Have received at least one dose of brigatinib according to approved indications.
排除标准
- •Note: There are no specific exclusion criteria.
结局指标
主要结局
Number of Participants Reporting One or More Non-serious Adverse Events (Non-SAEs)
时间窗: Up to 24 week
Number of Participants Reporting One or More AEs
时间窗: Up to 24 week
Number of Participants Reporting One or More Serious Adverse Events (SAEs)
时间窗: Up to 24 week
Number of Participants Reporting One or More Adverse Events (AEs) of Special Interest
时间窗: Up to 24 week
AEs of special interest includes Pneumonitis, interstitial lung disease, including early onset pulmonary events or symptoms; Hypertension; Bradycardia; Drug interactions with strong or moderate CYP3A inhibitors and inducers; hepatic toxicity; Myopathy, including elevation of creatine phosphokinase rhabdomyolysis and cardiomyopathy; Pancreatitis including elevation of lipase and amylase; Macular degeneration, retinopathy and visual disturbances and Embryo-fetal toxicity.
次要结局
- Objective Response Rate (ORR)(Up to 24 week)
- Central Nervous System Objective Response Rate (CNS-ORR)(Up to 24 week)
- Overall Survival (OS)(From first administration of study drug to death (up to 24 week))
- 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 week))