EUCTR2018-002480-26-DK
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)
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- ovartis Pharma AG
- 入组人数
- 245
- 状态
- 进行中（未招募）
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •The main inclusion criteria are listed below. Other inclusion criteria, defined in the protocol, may apply.
- •3\.Histologically confirmed locally advanced/metastatic (stage IIIBIV)
- •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.
- •8\.Serum lipase \= 1\.5 x ULN.
- •8\.Creatinine clearance \= 60 mL/ min by calculation using Cockcroft\-
- •Gault formula.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
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.
- •2\.Subjects with pure squamous cell histology that are known to have
- •EGFR/ ALK sensitizing mutations are excluded.
- •2\.Subjects with known BRAF V600 mutation or ROS1 rearrangement will
- •be excluded if required by local guidelines.
- •History of severe hypersensitivity reaction to monoclonal antibodies, taxanes or excipients of docetaxel or canakinumab.
- •6\.Subject with suspected or proven immunocompromised state or
- •infections, including evidence of active or latent tuberculosis (TB) as
结局指标
主要结局
未指定
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