JPRN-jRCT2031200248进行中(未招募)2 期
Phase II study of necitumumab and pembrolizumab in patients with PD-L1 high-expressing non-small-cell lung cancer - K-TAIL-202
Horiike Atsushi0 个研究点目标入组 50 人开始时间: 2020年12月15日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 50
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
- •We determine patients who are obtained document agreement by free will after the explanation using informed consent form, satisfy all of the following selection criteria, do not conflict with exclusion criteria, have been judged to be eligible for participation in this study by the research doctor as subjects.
- •1) Histologically confirmed advanced non-small cell lung cancer
- •2) PD-L1 expression in more than 50% of tumor cells as determined by immunohistochemistry
- •3) Lacking epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) translocation
- •4) Measurable lesion by RECIST ver1.1
- •5) Performance status 0 to 1 (ECOG)
- •6) Age at agreement acquisition is over 20 years old
- •7) Life expectancy is at least 3 months
- •8) Adequate organ function
排除标准
- •We exclude persons who corresponding to any of the following criteria from this study.
- •1) Medical history that may have an impact on the evaluation and safety of this study (heart, liver, kidney, lung , blood disorder etc.)
- •2) History or complication of autoimmune disease
- •3) Continuously using systemic corticosteroid
- •4) Pericardial, pleural effusion or ascites to need drainage
- •5) Pregnant or lactating women, or men and women with wanting pregnancy
- •6) Persons who has been judged unsuitable as subjects of this study by the research doctor
研究者
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