NL-OMON35789已完成3 期
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. - Roche BO25460 NSCLC Tarceva
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 32
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
- 18 至 99（—）
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 cycle - ECOG performance status 0-1
- •(for complete inclusion criteria see protocol p34-35)
排除标准
- •- Prior exposure to agents directed at HER axis (e.g. erlotinib, gafitinib, cetuximab)
- •- Patients whose tumours harbour EGFR activating mutation
- •- Prior chemotherapy or therapy with systemic anti-neoplastic therapy for advanced disease before screening (platinum-based chemotherapy)
- •- Use of pemetrexed in maintenance setting (pemetrexed is allowed during the chemotherapy run-in)
- •- Patients who have undergone complete tumour resection after responding to 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
- •(for complete exclusion criteria see protocol p35-36)
研究者
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