JPRN-jRCTs041190027进行中（未招募）2 期
A phase 2 study of afatinib for advanced non-small cell lung cancer with uncommon epidermal growth factor receptor (EGFR) mutation including compound mutation detected by next generation sequencing
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 17
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) Non-small cell lung cancer proven by histology and/or cytology 2) Confirmed diagnosis of stage III (not amenable for curative intent local radiotherapy), IV or postoperative/post chemoradiation therapy recurrence 3) single or compound uncommon EGFR mutaion detected by NGS with the exclusion of T790M mutaion or exon 20 insertion 4) 20 years or older 5) ECOG PS 0 or 1 6) No prior treatment with EGFR-TKI 7) At least one or more measurable lesion by RECIST 8) Adequate organ function 9) Written informed consent for translational research Written informed consent
排除标准
- •1) Patients with resistance EGFR mutations (T790M mutaion or exon 20 insertion) 2) Severe active infections 3) Severe diarrhea 4) Evidence of interstitial desease such as Idiopathic pulmonary fibrosis, pneumoconiosis and drug-induced pneumonitis 5) Patients unable to swallow oral medications 6) Under treatment of high-dose steroid therapy or immunosuppressive therapy 7) History of allergic reaction Decision of ineligibility by a physician 8) Prior treatment withimmune-checkpoint inhibitors within 3 months 9) Symptomatic brain metastasis/ leptomeningitis 10) Uncontrollable pleural, peritoneal or pericardial effusion 11) Prior palliative radiotherapy within 1weeks 12) Uncontrolled or severe hypertention, diabetes mellitus, active bleeding of the digestive tract, and known history of cardiovascular disease including congestive heart failure, myocardial infarction or unstable angina within 6 months. 13) No intention to birth control
研究者
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