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临床试验/EUCTR2018-001547-32-FR
EUCTR2018-001547-32-FR进行中(未招募)1 期

A randomized, double-blind, placebo-controlled, phase III study evaluating the efficacy and safety of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab as first line therapy for locally advanced or metastatic non-squamous and squamous non-small cell lung cancer subjects (CANOPY-1)

ovartis Pharma AG0 个研究点目标入组 627 人开始时间: 2018年10月19日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
627

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

入选标准

  • 1. Histologically confirmed locally advanced or metastatic NSCLC
  • 2. Measurable disease by RECIST 1.1
  • 3. Known PD-L1 status
  • 4. ECOG performance status (PS) = 1.
  • 5. Other protocol-defined inclusion criteria may apply.
  • 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 314
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 313

排除标准

  • 1. Previous immunotherapy or treatment with IL-1ß inhibitor.
  • 2. Subjects with epidermal growth factor receptor (EGFR) sensitizing mutations and/or ALK rearrangement
  • 3. History of severe hypersensitivity reaction to monoclonal antibodies, platinum containing drugs, nab-paclitaxel, paclitaxel, pemetrexed or any known excipients of these drugs
  • 4. Other protocol-defined exclusion criteria may apply.

研究者

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