JPRN-jRCTs031180404进行中（未招募）2 期
A phase II trial of induction erlotinib followed by surgical resection in patients with pathologically confirmed stage IIIA-N2 EGFR mutated non-small cell lung cancer.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Suzuki Kenji
- 入组人数
- 25
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1) Histologically or cytologically proven EGFR mutated (Ex19 deletions or Ex21 L858R) non-small cell lung cancer diagnosed using specimen material obtained from primary tumor or metastastatic lymph node
- •(2) Stage IIIA- pathologically proven N2 disease
- •(3) Without previously treatment for lung cancer
- •(4) Age >=20
- •(5) ECOG PS 0-1
- •(6) Expected FEV 1.0 > 800ml after lung resection, SpO2 (Room air) >93%
- •(7) Adequate organ function
- •(8) Written informed consent
排除标准
- •(1) EGFR mutation T790M postive
- •(2) Interstitial pneumonia or pulmanary fibrosis detectable on chest CT scan
- •(3) Privious history of drug induced lung injury
- •(4) Uncontrollable systemic disease (hyper tension, diabetes mellitus etc.)
- •(5) Aactive infection
- •(6) History of congestive heart failure, angina pectoris or myocardial infarction withinthe last 1 year.
- •(7) Unterated bone fracture or serious wound
- •(8) Severe diarrhea
- •(9) Current or previous (within the last 1 year) history of GI perforation or diverticultis
- •(10) Ireus
- •(11) Severe drug allergy
- •(12) Investigational new drug or the unapproved drug is administered
- •(13) History of active double cancer
- •(14) History of pregnancy or lactation
- •(15) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator
研究者
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