EUCTR2014-001263-12-IT进行中（未招募）不适用
Crizotinib in pretreated metastatic non-small-cell lung cancer with MET amplification or ROS1 translocation (METROS) - METROS
Fondazione Ricerca Traslazionale (FoRT)0 个研究点开始时间: 2014年6月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Histologically confirmed diagnosis of NSCLC
- •Availability of tumor tissue for ROS1, and MET analyses
- •Patient positive for ROS1 translocation or MET amplification
- •Radiological measurable disease according to RECIST criteria
- •At least 1 previous standard chemotherapy regimen
- •Performance status 0-2 (ECOG)
- •Patient compliance to trial procedures
- •Age = 18 years
- •Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •No tumor tissue available or patient negative for ROS1 translocation or MET amplification
- •Absence of any measurable lesions
- •For ROS1+ patients: Previous therapy with crizotinib or any anti-ALK agents
- •For MET amplified patients: Evidence of MET amplification in tumor tissue collected in EGFR mutant patient at time of EGFR-TKI acquired resistance occurrence. An EGFR mutant patient is eligible if MET amplification is detected in a tumor specimen collected before starting an EGFR-TKI
- •No previous chemotherapy
- •Concomitant radiotherapy or chemotherapy
- •Symptomatic brain metastases
- •Diagnosis of any other malignancy during the last 5 years, except for in situ carcinoma of cervix uteri and cutaneous squamous cell carcinoma
- •Pregnancy or lactating
研究者
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