EUCTR2014-001285-10-DE进行中（未招募）不适用
An Open-Label, Multicenter Clinical Trial with Nivolumab (BMS-936558) Monotherapy in Subjects with Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) who Have Received at Least Two Prior Systemic Regimens for the Treatment of Stage IIIb/IV SqNSCLC - CheckMate 171: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 171
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,800
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
- •Key Inclusion Criteria
- •a) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS):
- •i) PS 0 to 1 (Subgroup1)
- •ii) PS 2 (Subgroup 2; maximum of 300 subjects; clinical risk/benefit ratio will be monitored by the Scientific Steering Committee following a Safety Management Plan
- •b) Subjects with histologically or cytologically-documented SqNSCLC who presented with stage IIIb/stage IV disease or who developed recurrent or progressive disease following prior definitive therapy for localized or local advanced disease. Enrollees must not be eligible for another clinical study with nivolumab. A fresh biopsy is not required to take part in the study.
- •c) Subjects must have experienced disease progression or recurrence during or after both a platinum doublet-based chemotherapy regimen and at least 1 additional systemic therapy
- •i) Additional systemic therapies are defined as agents that are locally accepted and established for use as monotherapy or in combination for the treatment of stage IIIb/stage IV SqNSCLC.
- •ii) Experimental therapies when given as a separate regimen are considered as separate lines of therapy.
- •iii) Maintenance therapy following platinum doublet-based chemotherapy is not considered a separate line of therapy.
- •iv) Prior platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease is considered first-line therapy only if recurrent (local or metastatic) or progressive disease developed within 6 months of completing therapy. Subjects with recurrent disease > 6 months must also have progressed during or after at least 2 subsequent regimens (a platinum doublet-based chemotherapy regimen and at least 1 additional systemic therapy OR at least 2 additional systemic therapies) given to treat the recurrence
- •d) Subjects with CNS metastases:
- •i) Subjects are eligible if CNS metastases are treated and subjects are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to first dose. In addition, subjects must be either off corticosteroids or on a stable or decreasing dose of < or = 10 mg daily prednisone (or equivalent)
- •ii) Subjects are eligible if they have previously untreated CNS metastases that are neurologically asymptomatic. In addition, subjects must be either off corticosteroids or on a stable or decreasing dose of < or = 10 mg daily prednisone (or equivalent)
- •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 1600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •Key exclusion criteria:
- •a) Subjects with untreated, symptomatic CNS metastases are excluded
- •b) Subjects with carcinomatous meningitis are excluded.
研究者
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