JPRN-jRCT2031210004招募中2 期
Phase II Study of Entrectinib in Patients with Advanced Non-Small-Cell Lung Carcinoma harboring ROS1 Rearrangement detected by Liquid Biopsy
osaki Kaname0 个研究点目标入组 18 人开始时间: 2021年4月2日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
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
- •Histologically- or cytologically-confirmed diagnosis of NSCLC.
- •-Stage III , IV or postoperative recurrence with unresectable and incapable radical radiation therapy.
- •-Liquid NGS analysis revealed that the ROS1 fusion gene.
- •-one or more non-irradiated measurable lesions according to RECIST v1.1
- •-Males and females age >= 20 years on the date of informed consent for study participation
- •-An ECOG PS score of 0-2
- •-Has sufficient organ functions
- •-The patient has signed a written consent form after receiving written information about the trial prior to enrollment
排除标准
- •-Participating in another trial and receiving treatment
- •-History of ROS1 inhibitor administration
- •-Has not recovered to grade 1 from acute toxicity of prior treatment
- •-Symptomatic central nervous system metastasis
- •-CT-confirmed or a history of interstitial pulmonary fibrosis, pneumonitis or interstitial lung disease
- •-Patients with current/ medical history such as; myocardial infarction, angina, bypass grafting of coronary or periperal arteries, heart failure and stroke including transient ischemic attack within the past 3 months prior to Day 1.
- •-Pregnancy or breastfeeding
- •-Patients with a history of hypersensitivity to Entrectinib or Entrectinib vehicles
研究者
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A-LiquidJPRN-jRCT2080225060Department of Thoracic Oncology, National Cancer Center Hospital East25
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