JPRN-jRCTs031180175进行中（未招募）3 期
Phase III study of afatinib or chemotherapy in patients with non-small cell lung cancer harboring sensitizing uncommon epidermal growth factor receptor mutations - ACHILLES study/TORG1834
TANAKA Hiroshi0 个研究点目标入组 106 人开始时间: 2019年3月4日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 106
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 and/or cytologically documented non-squamous, non-small cell lung cancer patients with stage IIIB, IIIC or IV, and who are ineligible for curative radiotherapy, or relapsed after postoperative chemotherapy or chemoradiotherapy for locally advanced disease.
- •2) Sensitizing EGFR Uncommon mutation patient ((1).or(2) with(3))
- •(1) Patient with EGFR uncommon mutations
- •(2) Patient with compound mutations
- •(3) Patient without resistant EGFR uncommon mutation (T790M, Exon 20 insertions)
- •3) No prior therapy with chemotherapy, molecular targeted therapy and immune-check point inhibitors
- •4) 20 years or older
- •5) ECOG PS 0 or 1
- •6) Adequate organ function
- •7) Patients with at least one evaluable lesion
- •(regardless of whether lesions can be measured using RECIST version 1.1)
- •8) Life expectancy more than three months
- •9) Written informed consent for translational research
- •Written informed consent
排除标准
- •1)Patients who are difficult to treat enrolled doses due to toxicity of afatinib
- •2)History of drug-induced pneumonitis/Interstitial pneumonia detectable with chest CT scan.
- •3)Symptomatic brain metastasis/ leptomeningitis
- •4)Bone metastasis to treat by operation or radiation therapy
- •5)Uncontrollable pleural, peritoneal or pericardial effusion
- •6)Prior thoracic palliative radiotherapy within 2wks
- •7)SCLC transformation
- •8)History of active double cancer
- •9)Severe infection
- •10)Active HBV infection
- •11)No intention to birth control
- •12)Unstable psychic disorder
- •13)Under treatment of steroid therapy or immunosuppressive therapy
- •14)History of allergic reaction
- •Decision of ineligibility by a physician
研究者
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