NCT05599412招募中不适用
A Prospective, Single-arm, Open-label, Non-interventional, Multi-centre, Post Marketing Surveillance (PMS) Study of Lorviqua (Registered)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Incidence of the adverse events from baseline
研究概览
简要总结
The objective of this study is to monitor the usage of Lorviqua in real practice within label, including the adverse events associated with Lorviqua
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- •Use in the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC)
- •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 meeting any of the following criteria will not be included in the study:
- •Patients to whom Lorviqua® is contraindicated as per the local labeling. A. Hypersensitivity to Lorviqua® or to any of the excipients of this product B. Lorviqua® is contraindicated in patients taking concomitant use of strong CYP3A4/5 inducers C. This medicinal product contains lactose as an excipient. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose galactose malabsorption should not take this medicinal product.
- •Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information
研究组 & 干预措施
Korean patients with Metastatic ALK+ Non small cell lung cancer
干预措施: Lorviqua (Drug)
结局指标
主要结局
Incidence of the adverse events from baseline
时间窗: Up to 2 years
This is a prospective, observational, non-interventional, multi-center study in which subjects will be administered as part of routine practice at Korean health care centers by accredited physicians.
次要结局
- Complete Response (CR)(Up to 2 Years)
- Stable Disease (SD)(Up to 2 years)
- Progressive Disease (PD)(Up to 2 years)
- Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)(Up to 2 years)
- Partial Response (PR)(Up to 2 years)
研究者
研究点 (1)
Loading locations...
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