An Observational Study of GIOTRIF (Afatinib) for First Line Therapy in Patients With Advanced Non Small Cell Lung Cancer (NSCLC) Harboring Epidermal Growth Factor Receptor (EGFR)-Mutations.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 161
- 主要终点
- Progression Free Survival (PFS) Rate After 12 Months
研究概览
简要总结
This observational study will investigate the efficacy, safety, tolerability and symptom control of GIOTRIF (Afatinib) in daily routine first-line therapy in patients with locally advanced or metastatic NSCLC harboring EGFR-mutations. Eligible NSCLC patients, for whom the treating physician has decided to initiate treatment with GIOTRIF in first line according to the local label, will be followed up for approximately 24 months.
详细描述
Study Design:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Afatinib
干预措施: Afatinib (Drug)
结局指标
主要结局
Progression Free Survival (PFS) Rate After 12 Months
时间窗: After 12 months
The rate (probability) of being progression free after 12 months. PFS is defined as the time from first administration of the trial drug until objective tumor progression or death. The rate is the Kaplan-Meier estimated percent probability.
次要结局
- Objective Response Rate (ORR)(From the initial dose of study drug until end of the treatment period, up to 48 months.)
- Disease Control Rate (DCR)(From the initial dose of study drug until end of the treatment period, up to 48 months.)
- Progression Free Survival (PFS)(From first administration of the trial drug until objective tumour progression or death, up to 48 months.)
- Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.)
- Toxicity and Side-effect Profile: Incidence of Diarrhea, Skin Reactions, Stomatitis and Paronychia(From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.)
- Treatment Duration(From the initial dose of study drug until end of the treatment period, up to 48 months.)
- Symptom Control - Time to Worsening (Cough, Dyspnea and Pain)(Up to 48 months)
- Percentage of Participants With Treatment Modification(From the initial dose of study drug until end of the treatment period, up to 48 months.)