Phase II Pilot Study of Subsequent Line Gemcitabine and Nivolumab for Advanced SCLC
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Number of Participants With Positive Responses to Therapy Per Response Evaluation Criteria in Solid Tumors (RECIST)
研究概览
简要总结
This phase II pilot trial studies how well gemcitabine and nivolumab work in treating participants with small cell lung cancer that has spread to other parts of the body after other treatments have failed. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving second-line gemcitabine and nivolumab may work better in treating participants with small cell lung cancer.
详细描述
PRIMARY OBJECTIVES:
I. To compare response rate (RR) of gemcitabine and nivolumab (G+N) after 4 cycles (8 weeks) to historical controls treated with nivolumab alone.
SECONDARY OBJECTIVES:
I. To compare median overall survival (OS) of G+N to historical controls treated with nivolumab alone.
II. To compare median progression-free survival (PFS) of G+N to historical controls treated with nivolumab alone.
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
- •Patients must have histologically or cytologically confirmed incurable SCLC and have had prior treatment with platinum-based chemotherapy. High-grade neuroendocrine tumors that are suspected to be of bronchopulmonary origin can be enrolled if they have had prior treatment with a SCLC chemotherapy regimen (e.g. platinum plus etoposide).
- •Patients should not be demonstrating end-organ damage due to rapid progression of disease based on the most recent assessment of the treating physician.
- •Patients must have radiographically measurable metastatic disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Absolute neutrophil count >= 1,500/mcL.
- •Platelets >= 100,000/mcL.
- •Chemotherapy agents are known to be teratogenic, therefore women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document.
排除标准
- •Patients who have previously received either gemcitabine or an immune checkpoint inhibitor can be enrolled.
- •Emergent need for palliative radiation.
- •Patients may not be receiving any other investigational agents for the treatment of nonsmall cell lung cancer.
- •History of allergic reaction to gemcitabine.
- •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects with chemotherapy. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with chemotherapy, breastfeeding should be discontinued.
研究组 & 干预措施
Treatment (gemcitabine, nivolumab)
Participants receive gemcitabine IV over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
干预措施: Gemcitabine (Drug)
Treatment (gemcitabine, nivolumab)
Participants receive gemcitabine IV over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
干预措施: Nivolumab (Biological)
结局指标
主要结局
Number of Participants With Positive Responses to Therapy Per Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: Up to 8 weeks
Objective RR (complete response \[CR\] + partial response \[PR\]) will be compared between this study sample and a historical benchmark value of 10%. For this comparison we will use a one-sample test of proportion. * Complete Response (CR): Disappearance of all target lesions. * Partial Response (PR): Decrease by ≥ 30% in sum of longest diameter of target lesions. * Stable Disease (SD): Not meeting criteria for CR, PR, or PD. * Progressive Disease (PD): Increase by ≥ 20% in sum of longest diameter of target lesions or the appearance of one or more new lesions. The response in non-target lesions is defined as follows: * Complete Response (CR): Complete disappearance of all non-target lesions. * Stable Disease (SD): Persistence of one or more non-target lesion(s). * Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
次要结局
- Number of Adverse Events(Up to 2 years)
- Overall Survival (OS) - Number of Participants(Duration of time from the start of treatment to date of death, assessed up to 2 years)
- Overall Survival (OS) - Months(Duration of time from the start of treatment to date of death, assessed up to 2 years)
- Progression-free Survival (PFS) - Number of Participants(Duration of time from the start of treatment to the time of investigator assessed progression or death, assessed up to 2 years)
- Progression-free Survival (PFS) - Months(Duration of time from the start of treatment to the time of investigator assessed progression or death, assessed up to 2 years)