JPRN-jRCTs071180037已完成3 期
A phase III study comparing nab-paclitaxel with docetaxel in patients with previously treated advanced non-small-cell lung cancer - J-AXE
Okamoto Isamu0 个研究点目标入组 503 人开始时间: 2019年3月11日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 503
研究概览
简要总结
The noninferiority of nab-paclitaxel relative to docetaxel was confirmed with regard to OS, and superiority was apparent with regard to PFS and ORR. Nab-paclitaxel for patients with advanced NSCLC previously treated with cytotoxic chemotherapy thus provides a clinically significant benefit in terms of its effectiveness and tolerability. Such treatment should therefore be considered a standard option for patients in this setting.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Histologically or cytologically confirmed diagnosis of NSCLC
- •2) Previously treated non-small cell lung cancer with stage IIIB, IV or recurrent disease
- •3) Patient previously treated with at least two regimens of chemotherapy
- •*Recurrence within a year or less from the day adjuvant chemotherapy finished is considered a previous treatment.
- •4) Age of 20 years or older
- •5) Performance Status (ECOG) 0-1
- •6) Tumor has the evaluable lesion
排除标准
- •1) Treatment history of taxanes
- •2) Synchronous or metachronous active double malignancies
- •3) Infectious disease requiring systemic treatment
- •4) Fever of 38 degrees centigrade or higher
- •5) Psychotic disorder
研究者
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