A Single Arm Phase IV Study of Afatinib in Elderly Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer Whose Tumors Have Epidermal Growth Factor Receptor (EGFR) Exon 19 Deletions or Exon 21(L858R) Substitution Mutations
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 10
- 主要终点
- Percentage of Participants Reporting an Adverse Event (AE) Leading to Dose Reduction of Afatinib
研究概览
简要总结
Continuous treatment until progression or occurence of intolerable Adverse Event (AE) or end of trial. The end of trial is one year after the last patient has entered the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（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
afatinib starting at 30 mg daily dose
干预措施: Afatinib (Drug)
结局指标
主要结局
Percentage of Participants Reporting an Adverse Event (AE) Leading to Dose Reduction of Afatinib
时间窗: On-treatment period + 28 days (residual effect period), up to 1057 + 28 days
On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent for study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria).
次要结局
- Percentage of Participants With Adverse Event = Rash/Acne (Grouped Term) of CTCAE Grade 3 or Higher(On-treatment period + 28 days (residual effect period), up to 1057 + 28 days)
- Percentage of Participants With Adverse Event = Diarrhoea of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or Higher(On-treatment period + 28 days (residual effect period), up to 1057 + 28 days)
- Percentage of Participants With Adverse Event = Stomatitis (Grouped Term) of CTCAE Grade 3 or Higher(On-treatment period + 28 days (residual effect period), up to 1057 + 28 days)
- Percentage of Participants With Adverse Event = Paronychia (Grouped Term) of CTCAE Grade 3 or Higher(On-treatment period + 28 days (residual effect period), up to 1057 + 28 days)
- Time to First Dose Reduction of Afatinib Caused by Adverse Events(On-treatment period, up to 1057 days)