An Open Label, Safety Study of Participants With Non-Small Cell Lung Cancer Receiving Second-Line Nivolumab Monotherapy in Asia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 30
- 主要终点
- Number of Non-HBV Participants Experiencing High Grade Treatment-Related Select Adverse Events
研究概览
简要总结
The purpose of this study is to investigate the safety of patients in Asia with Non-Small Cell Lung Cancer (NSCLC)who are treated with Nivolumab monotherapy as a second line or third line treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Advanced metastatic stage IIIB/IV NSCLC (Nonsquamous and squamous)
- •1 to 2 prior systemic therapies
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 1
- •Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)
- •Prior radiotherapy or radiosurgery must have been completed at least 2 weeks prior to starting study treatment
排除标准
- •Women with a positive pregnancy test at enrollment or prior to administration of study medication
- •Participants with active central nervous system metastases
- •Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first dose of study drug
- •Participants with previous malignancies are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required or anticipated to be required during the study period
- •Participants with carcinomatous meningitis
- •Other protocol defined inclusion/exclusion criteria could apply
结局指标
主要结局
Number of Non-HBV Participants Experiencing High Grade Treatment-Related Select Adverse Events
时间窗: From first dose up to 100 days post dose, up to approximately 36 months
Number of non-HBV participants experiencing high grade (combined CTCAE v4 Grade 3-4 and Grade 5) treatment-related select adverse events in non-HBV infected participants. To evaluate safety and tolerability in non-HBV infected participants with advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed during or after one prior systemic therapy and are treated with nivolumab monotherapy with an infusion duration of 30 minutes. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
次要结局
- Number of Participants Experiencing Serious Adverse Events (SAEs)(From first dose to 100 days post last dose, up to 36 months)
- Objective Response Rate(From the first dose date up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first. Up to approximately 36 months)
- Number of HBV Participants Experiencing High Grade Treatment-Related Select Adverse Events(From first dose up to 100 days post dose, up to approximately 36 months)
- Overall Survival (OS)(From the first dose up to the date of death. Participants without documentation of death will be censored on the late date known to be alive, up to approximately 32 months)
- Progression-Free Survival (PFS)(From the first dose up to the date of the first documented tumor progression (per RECIST 1.1) or death due to any cause, up to approximately 30 months)
- Number of Participants Experiencing Adverse Events (AEs)(From first dose up to 100 days post dose, up to approximately 36 months)
- Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests(From first dose up to 100 days post last dose, up to approximately 36 months)
- Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests(From randomization to 100 days post last dose, up to 36 months)
- Duration of Tumor Response(From the date of first confirmed response to the date of the first documented tumor progression, up to approximately 30 months)
- Time to Treatment Failure (TTF)(From treatment assignment to disease progression, death or last dose date, up to approximately 16 months)