EUCTR2018-001547-32-AT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)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 673
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
- •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 386
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 287
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.
- •5. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •6. Presence or history of a malignant disease, other than NSCLC, that has been diagnosed and/or required therapy within the past 3 years prior to randomization.
- •7. Active autoimmune disease that has required systemic treatment in the past 2 years prior to randomization (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).Control of the disorder with replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is permitted.
- •13. History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
研究者
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