NL-OMON45179已完成3 期
A randomized phase III study of erlotinib compared to intercalated erlotinib with cisplatinum pemetrexed as first-line therapy for advanced EGFR mutated non-small-cell lung cancer. the NVALT-17 study - NVALT17
Stichting NVALT studies0 个研究点目标入组 150 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
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
- •Histologically/cytologically proven stage III or IV non-sqamous NSCLC.
- •Tumor treatment-naive.
- •Documented activating EGFR mutation in exon 18, 19 or exon 21.
- •Measurable disease.
- •Age >= 18 years.
- •ECOG Performance Status of 0 - 3.
- •Life expectancy > 12 weeks.
- •Adequate contraception for females of childbearing potential.
- •Adequate contraception for male participants.
排除标准
- •Documented brain metastasis. Exceptions: see protocol page 12.
- •Concomitant treatment with experimental medicines, potent CYP3A4 inhibitors or inducers, see protocol page 12 for details.
- •Previous cytotoxic chemotherapy for lung cancer less than 2 years before study entry.
- •For curatively treated lung cancer: (adjuvant) chemotherapy or chemo-radiotherapy less than 12 month prior to the study entry.
- •Pregnancy or lactation.
研究者
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