NCT04213937Unknown2 期
The Efficacy and Safety of Nab-paclitaxel Versus Topotecan As Second-Line Treatment for Patients With Extensive Stage Small Cell Lung Cancer: A Multicenter, Randomized Controlled Study
Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 386 人开始时间: 2020年1月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 386
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of nab-paclitaxel with topotecan as second-line treatment for patients with extensive stage small cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.18 to 75years, male or female; 2.Histological or pathological diagnosis of small cell lung caner; 3.Progression or relapse after first-line chemotherapy, extensive disease; 4.ECOG performance status of 0-2; 5.Life expectancy of 3 months or more; 6.Patient must be accessible for treatment and follow-up; 7.For women of child-bearing age, the pregnancy test results (serum or urine) within 72 hours before enrolment must be negative. They will take appropriate methods for contraception during the study; 8.Signed informed consent.
排除标准
- •symptomatic brain metastases;
- •Uncontrolled serious medical conditions that, in the opinion of the investigator, would affect the ability of the subject to receive the study regimen, such as concomitant serious medical conditions, including severe heart disease, cerebrovascular disease, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.;
- •Have dementia, altered mental state or any mental illness that would prevent understanding or informed consent or fill out questionnaires;
- •Received any investigational drug within 30 days of the planned first dose of this study treatment.
- •Prior Grade ≥ 2 peripheral neuropathy(according to (NCI CTCAE), version 5.0);
- •Known to be hypersensitive, highly sensitive, or intolerant to study-related medications or their excipients;
- •Have malignant tumors in the past 5 years, except for clinically cured basal cell or squamous cell skin cancer, local prostate cancer after radical operation, and ductal carcinoma in situ after radical operation;
- •Bone marrow function: Neutrophils < 1.5×109/L, platelets < 100×109/L, hemoglobin < 90 g/L; Hepatic and renal function: Serum creatinine > 1.5×ULN; AST and ALT > 2.5×ULN or > 5×ULN in the presence of hepatic metastasis; Total bilirubin >1.5×ULN;
- •Patients need other anti-tumor drugs;
- •Known HIV, hepatitis B/C virus positive ;
- •The researchers considered the patients who were not suitable for enrollment.
研究组 & 干预措施
nab-paclitaxel
Experimental
nab-paclitaxel 125mg/m2, i.v. d1, d8, Repeated every 3 weeks for 4-6 cycles
干预措施: nab-paclitaxel (Drug)
Topotecan
Active Comparator
Topotecan 1.25mg/m2/d, i.v, 1hour, d1-d5, Repeated every 3 weeks for 4-6 cycles.
干预措施: Topotecan (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: 1 years post treatment
OS was defined as the time from the date of the first administration of trial regimen to the date of death from any cause (event) or last follow-up (censored data).
次要结局
- Objective response rate (ORR)(1 years)
- Progression free survival (PFS)(1 years)
- Adverse events (AE)(3 years)
研究者
Jie Wang
Principal Investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
研究点 (1)
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