EUCTR2007-003709-29-IT进行中（未招募）不适用
Prospective phase II trial evaluating efficacy of Trastuzumab therapy in HER2 FISH positive and/or HER2 mutation positive, pretreated, Non-Small Cell Lung Cancer patients (MO20509) - ND
ISTITUTO CLINICO HUMANITAS0 个研究点开始时间: 2008年7月14日最近更新:
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 HER2 FISH analysis or HER2 gene mutation analysis is mandatory
- •Stage IIIB (with effusion) or stage IV or disease relapsed after surgery or radiotherapy and in any case not suitable for radiotherapy or surgery with curative intent
- •HER2 FISH positive defined as high polysomy or gene amplification, or presence of HER2 gene mutation in exon 20
- •At least one measurable lesion
- •Patients pretreated with at least one chemotherapy regimen. Previous therapy with erlotinib or other tyrosine kinase inhibitors is allowed.
- •Patients compliance to trial procedures
- •Age ≥ 18 years
- •Written informed consent
- •Adequate BM function (ANC ≥ 1.5x109/L, Platelets ≥ 100x109/L, HgB > 9g/dl)
- •Adequate liver function (bilirubin Normal level of alkaline phosphatase and creatinine.
- •If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of approved contraceptive method [intrauterine contraceptive device (IUD), birth control pills, or barrier device] during and for three months after end of treatment.
- •ECOG performance status 0-1 and life expectancy of at least 3 months
- •Have recovered from the acute, reversible effects of prior surgery or radiotherapy. This means that at least 3 weeks should have elapsed since prior radiotherapy.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •HER2 FISH negative tumor and no HER2 gene mutation
- •Concomitant radiotherapy
- •Untreated brain metastases or leptomeningeal disease involvement.
- •All disease sites previously included in radiotherapy fields. If all sites were included in radiotherapy fields patient is eligible only if there is evidence of progressive disease after completion of radiotherapy.
- •No measurable lesion
- •Left ventricular ejection fraction (FEV) <50%
- •Diagnosis of any other malignancy during the last 5 years, except for in situ carcinoma of cervix uteri and squamous cell carcinoma of the skin
- •Any previous HER2 blocking therapy. Previous therapy with anti EGFR agents is allowed
- •Pregnancy or lactating
- •Other serious illness or medical condition including: Congestive heart failure (NYHA class II, III, IV) or history of documented congestive heart failure, unstable angina pectoris, myocardial infarction in the last 12 months, poorly controlled hypertension (systolic >180 mmHg or diastolic >100 mmHg), clinically significant valvular heart disease, or high-risk uncontrolled arrhythmias. Patients with dyspnoea at rest due to malignant or other disease (e.g. pulmonary metastases with lymphangitis) or who require supportive oxygen therapy. Active serious uncontrolled infections. Poorly controlled diabetes mellitus
- •Treatment with any investigational drug within 30 days before the beginning of treatment with study drug.
研究者
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