JPRN-UMIN000020370已完成2 期
Phase 2 trial of the efficacy and safety of Afatinib for EGFR-TKI untreated EGFR gene mutation-Positive Elderly advanced or recurrent non-small cell lung Cancer. (APEC) - Phase II trial of afatinib treatment for elderly non-small cell lung cancer patients with EGFR gene mutations
Saitama Lung Cancer Research Group0 个研究点目标入组 40 人开始时间: 2015年12月27日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 75years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Patients with active double cancers (simultaneous double cancers and metachronous double cancers with less than 5 years disease-free interval) Exclusion: carcinoma in situ of cervix, gastric and colorectal cancers which can be radically resected by endoscope, and locally-resectable skin cancer except malignant melanoma 2) Patients with apparent interstitial pneumonia or pulmonary fibrosis on chest computed tomography 3) Patients with symptomatic brain metastases Exclusion: patients who have had stable symptoms more than 2 weeks after radiation therapy or more than 4 weeks after surgery 4) Patients with active infection 5) Patients requring continuous oxgen therapy 6) Patients who are in pregnancy or intend to get pregnant 7) Patients with a history of serious drug allergy 8) Patients with other serious complications 9) Patients with a history of allergy for a component of afatinib 10) Patients who are considered to have difficulty in enrollment of this trial based on clinically important psychiatric reasons 11) Patients who are considered to be inappropriate in enrollment of this trial by attending physicians
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