JPRN-jRCT1041180081已完成2 期
A phase II study of osimertinib in patients with poor performance status and EGFR mutation T790M-positive non-small-cell lung cancer
Murakami Haruyasu0 个研究点目标入组 18 人开始时间: 2019年3月12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
- 18
研究概览
简要总结
Osimertinib therapy demonstrated favorable efficacy and safety outcomes in patients with EGFR T790M mutation-positive advanced non-small cell lung cancer that have a poor PS.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1)ECOG PS 2, 3, or 4
- •2)Pathologically confirmation of non squamous non-small-cell lung cancer
- •3)Advanced non-small-cell lung cancer
- •4)History of using first-generation or second-generation EGFR-TKI
- •5)EGFR mutation with T790M in exon 20
- •6)Aged 20 or more
- •7)Written informed consent
排除标准
- •1)History of using third-generation EGFR-TKI
- •2)Uncontrolled symptomatic brain metastasis
- •3)Interstitial pneumonia or pulmonary fibrosis on imaging
- •4)QTc > 500 msec
- •5)Gastrointestinal disorder
- •6)Uncontrollable pleural effusion , ascites or pericardial effusion
- •7)Receiving the radiation therapy for chest
- •8)Severe complication
研究者
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