NCT02475382No Longer Available不适用
Expanded Access Program With Nivolumab Monotherapy in Subjects With Advanced or Metastatic Squamous (Sq) or Non-Squamous (Non-Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimens for the Treatment of Stage IIIb/IV SqNSCLC
Bristol-Myers Squibb2 个研究点 分布在 1 个国家开始时间: 2015年6月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 发起方
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to provide treatment with nivolumab, a fully human monoclonal antibody, to subjects who have relapsed after treatment with a minimum of 1 prior systemic treatment for advanced or metastatic squamous (Sq) or non-squamous (non-Sq) non-small cell lung cancer (NSCLC) , Stage IIIB/IV and whose physicians believe that nivolumab treatment is appropriate.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sq or Non-Sq NSCLC, Stage IIIb/IV (histologically or cytologically confirmed)
- •Relapsed after 1 prior platinum-based systemic treatment
- •Eastern Cooperative Oncology Group (ECOG) Performance Status < 2
- •CNS metastasis must be treated and returned to baseline at least 2 weeks before first dose of nivolumab and off steroids or using stable or decreasing dose of < 10 mg prednisone or equivalent
- •Prior chemotherapy, Tyrosine Kinase Inhibitor (TKI) therapy or Immunotherapy (tumor vaccine, cytokine or growth factor to control cancer) must be completed at least 2 weeks before first nivolumab dose
排除标准
- •CNS metastases (untreated and/or symptomatic)
- •Carcinomatous meningitis
- •ECOG Performance status > 3
- •Corticosteroids > 10 mg prednisolone/day (or equivalent)
- •Prior treatment with anti-PD-1, anti-PD-L-1, anti-PDL2, anti-CT137 or anti-CTLA antibody, including ipilimumab or any other drugs specifically targeting T cell costimulation or checkpoint pathways
研究者
研究点 (2)
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