JPRN-jRCTs041180055已完成2 期
Phase II study of low-dose afatinib for elderly patients with non-small cell lung cancer harboring EGFR mutation (based on TDM)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
研究概览
简要总结
This study results suggested the efficacies and safety of afatinib at a dose of 20 mg for elderly patients with non-small cell lung cancer harboring EGFR mutations.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 75age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Pathologically confirmation of non-small cell lung cancer
- •2) Clinical stage IIIB, IV, or postoperative recurrence
- •3) With activating EGFR mutation (Deletion in exon 19 or L858R in exon 21)
- •4) ECOG performance status 0-2
- •5) No prior therapy of EGFR-TKI
- •6) Measurable lesions based on RECIST ver1.1
- •7) Adequate organ functions
- •8) Written informed consent
排除标准
- •1) Interstitial lung disease
- •2) Receiving continuous systemic corticosteroid
- •3) During pregnancy or lactation
- •4) Psychological disorder difficult to participate in this clinical study
研究者
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