NCT02226757Unknown2 期
Paclitaxel-trastuzumab in EGFR-mutated NSCLC Patients After Progression on TKI-treatment; a Pilot-study
Amsterdam UMC, location VUmc1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2014年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
This study is a pilot study in EGFR-mutated NSCLC patients who have progressed on standard-dose TKIs. Tumor biopsies will be evaluated for HER2-expression. In case of HER2 expression, patients can participate in the trial after obtaining informed consent.
Patients will be treated with weekly paclitaxel-trastuzumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed stage IV non-squamous NSCLC patients.
- •Patients must have been detected with an activating EGFR mutation at baseline and must have yet progressed on erlotinib, gefitinib or afatinib monotherapy in daily dose of 150 mg, 250 mg or 40 mg respectively. (Patients with unknown mutation status that have exhibited a response to these agents or stable disease for at least 6 months while on treatment with gefitinib or erlotinib are also eligible).
- •Rebiopsy after having acquired resistance to TKI-treatment must have been performed and HER2-overexpression (positive immunohistochemistry staining) must have been detected.
- •There must be at least one measurable disease site, according to RECIST 1.1 criteria.
- •WHO performance status 0-
- •Willing and able to comply with the study prescriptions.
- •18 years or older.
- •Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study.
- •Ability to give written informed consent before patient registration.
排除标准
- •No uncontrolled infectious disease.
- •No other active malignancy.
- •No major surgery (excluding diagnostic procedures like e.g. mediastinoscopy or VATS biopsy) in the previous 4 weeks.
- •No treatment with investigational drugs.
- •No known hypersensitivity to trastuzumab-paclitaxel
- •No symptomatic brain metastases.
- •History of coronary artery disease, NYHA class III or IV and Left Ventricular Ejection Fraction (LVEF) of <45%.
研究组 & 干预措施
Paclitaxel-trastuzumab
Experimental
Paclitaxel-trastuzumab weekly
干预措施: Paclitaxel-trastzumab (Drug)
结局指标
主要结局
Objective response rate
时间窗: 6 weeks
次要结局
- Disease control rate(6 weeks)
- progression-free survival(2 years)
- Toxicity(2 years)
研究者
Prof. dr. E.F. Smit
MD PhD
Amsterdam UMC, location VUmc
研究点 (1)
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