EUCTR2018-002480-26-ES进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, phase III study evaluating the efficacy and safety of canakinumab in combination with docetaxel versus placebo in combination with docetaxel in subjects with non-small cell lung cancer (NSCLC) previously treated with PD-(L)1 inhibitors and platinum-based chemotherapy (CANOPY-2)
ovartis Farmacéutica S.A.0 个研究点目标入组 244 人开始时间: 2018年10月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 244
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
- •The main inclusion criteria are listed below. Other inclusion criteria, defined in the protocol, may apply.
- •Histologically confirmed locally advanced (stage IIIB) or metastatic NSCLC.
- •Subject has received one prior platinum-based chemotherapy and one prior PD-(L)1 inhibitor therapy for locally advanced or metastatic disease.
- •Subject with ECOG performance status (PS) of 0 or 1.
- •Subject with at least 1 evaluable (measurable or non measurable) lesion by RECIST 1.1 in solid tumors criteria.
- •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 122
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 122
排除标准
- •The main exclusion criteria are listed below. Other exclusion criteria, defined in the protocol, may apply.
- •Subject who previously received docetaxel, canakinumab (or another IL-1ß inhibitor), or any systemic therapy for their locally advanced or metastatic NSCLC other than one platinum-based chemotherapy and one prior PD-(L)1 inhibitor.
- •Subject with EGFRor ALK positive tumor. .
- •History of severe hypersensitivity reaction to monoclonal antibodies, taxanes or excipients of docetaxel or canakinumab.
研究者
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