Continuation of TKI With or Without Chemotherapy Beyond Gradual Progression
Phase II Study of Continuation of Tyrosine Kinase Inhibitor (TKI) With or Without Chemotherapy Beyond Gradual Progression in Advanced Non-small Cell Lung Cancer (NSCLC)
研究概览
地位
条件
详细说明
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
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Zhejiang
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Hangzhou、Zhejiang、中国、310003
- 招聘中
- Qiong Zhao
-
接触:
- Qiong Zhao, PhD
- 电话号码:0571-87236802
- 邮箱:doczq.2008@gmail.com
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion criteria:
Patient who was confirmed stage IV NSCLC by pathologic histology or cytology. Males or females aged ≥18 years, < 75 years. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Life expectancy ≥12 weeks.
Males and females should be contraceptive during the period of the trial until 8 weeks after the last administration of the drug.
Definition of gradual progression:
- Slow PD (6 months of partial response/stable disease),
- Asymptomatic minimal PD,
- New brain metastasis controlled locally. Patients with asymptomatic, treated brain metastases are eligible for trial participation.
Adequate bone marrow, renal, and liver function are required. Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
Institutional review board-approved informed consent will be obtained for every patient before initiation of any trial-specific procedure or treatment.
Exclusion criteria: Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.
Female subjects should not be pregnant or breast-feeding. Adequate hematological function: Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L.
Adequate renal function: Serum creatinine ≤ 1.5 x ULN, or ≥ 50 ml/min. Adequate liver function :Total bilirubin £ 1.5 x upper limit of normal (ULN) and Alanine Aminotransferase (ALT )and Aspartate Aminotransferase (AST )< 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases.
Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Arm A
TKI alone until rapid progression
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Arm A
其他名称:
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实验性的:Arm B
TKI combined with investigator's choice of chemotherapy regimen and subsequent line of treatment until rapid progression.
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Arm B
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Progression free survival
大体时间:up to 18 months
|
up to 18 months
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Objective response rate cacy
大体时间:up to 18 months
|
up to 18 months
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其他结果措施
结果测量 |
大体时间 |
---|---|
生活质量
大体时间:长达 24 个月
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长达 24 个月
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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