EUCTR2010-024468-16-CZ进行中（未招募）不适用
A randomized, double-blind, placebo-controlled Phase III study of first-line maintenance Tarceva vs Tarceva at the time of disease progression in patients with advanced non-small cell lung cancer (NSCLC) who have not progressed following 4 cycles of platinum-based chemotherapy.
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 610
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
- •- Adult patients, >/= 18 years of age (or >/= legal age of consent if greater than 18)
- •- Advanced or recurrent (Stage IIIb) or metastatic (Stage IV) non-small cell lung cancer (NSCLC)
- •- Completion of 4 cycles of platinum-based chemotherapy without progression (end of last chemotherapy cycle - ECOG performance status 0-1
- •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 407
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 203
排除标准
- •- Prior exposure to agents directed at HER axis (e.g. erlotinib, gafitinib, cetuximab)
- •- Patients whose tumours harbour an EGFR activating mutation
- •- Prior chemotherapy or therapy with systemic anti-neoplastic therapy for advanced disease before screening (platinum-based chemotherapy)
- •- Use of premetrexed in maintenance setting (pemetrexed is allowed during the chemotherapy run-in)
- •- Patients who have undergone complete tumour resection after responding to the platinum-based chemotherapy during the screening phase
- •- Any other malignancies within 5 years, except for curatively resected carcinoma in situ of the cervix, basal or squamous cell skin cancer, ductal carcinoma in situ or organ confined prostate cancer
- •- CNS metastases or spinal cord compression that has not been definitely treated with surgery and/or radiation, or treated CNS metastases or spinal cord compression without stable disease for >/= 2 months
- •- HIV, hepatitis B or hepatitis C infection
- •- Any inflammatory changes of the surface of the eye
研究者
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