NCT02285361已完成不适用
A Regulatory Requirement Post-marketing Surveillance Study to Monitor the Safety and Efficacy of GIOTRIF® (Afatinib Dimaleate, 20mg, 30mg, 40mg, q.d) in Korean Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Mutations or Patients With Locally Advanced or Metastatic NSCLC of Squamous Histology Progressing on or After Platinum-based Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,272
- 主要终点
- Percentage of Participants With Adverse Drug Reactions (ADRs)
研究概览
简要总结
To monitor the safety profile and efficacy of GIOTRIF® (afatinib dimaleate, q.d) in Korean patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
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 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
GIOTRIF
干预措施: GIOTRIF 20mg (Drug)
GIOTRIF
干预措施: GIOTRIF 40mg (Drug)
GIOTRIF
干预措施: GIOTRIF 30mg (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Drug Reactions (ADRs)
时间窗: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 1051 days.
Percentage of participants with Adverse Drug Reactions (ADRs).
次要结局
- Progression-Free Survival (PFS) Rate at 48 Weeks(From week 0 until week 48. Up to 48 weeks.)
- Percentage of Participants With Best Response(Tumour assessments performed at week 0, 8±2, 24±2 and 48±2. Up to 50 weeks.)
- Overall Survival (OS)(From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 1051 days.)
研究者
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