Clinical Study of Utidelone Injection in Patients With Advanced Non-small Cell Lung Cancer（NSCLC）

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追踪信息

首次提交日期 ^ICMJE

September 29, 2018

首次发布日期e ^ICMJE

October 3, 2018

最后更新发布日期

October 3, 2018

预计研究开始日期 ^ICMJE

October 8, 2018

预计主要完成日期

October 31, 2019 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Tumor response to utidelone treatment[ Time Frame: 6 months from first study treatment ]

Reflected by percentage of tumor size reduction or regression, assessed by imaging techniques and expressed as Objective Response Rate (ORR）ORR is defined as the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR) according to RECIST. 1.1.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Progression free survival (PFS)[ Time Frame: 1 year from first study treatment ]
PFS is defined as the duration of time from first study treatment to disease progression or death from any cause as documented by the investigator
Overall survival (OS)[ Time Frame: 2 year from enrolment ]
OS is defined as the duration of time from first study treatment until death from any cause.
Incidence of treatment-emergent adverse events based the Common Terminology Criteria for Adverse Events (CTCAE) version 4·03[ Time Frame: 1 year from first study treatment ]
Observe and record incidence of adverse events and severe adverse events associated with utidelone treatment, assessed by investigators according to CTCAE version 4·03

描述性信息

简略标题 ^ICMJE

Clinical Study of Utidelone Injection in Patients With Advanced Non-small Cell Lung Cancer（NSCLC）

正式标题 ^ICMJE

Open, Multicenter, Monotherapy, Phase II Clinical Study of Utidelone Injection in Patients With Advanced Non-small Cell Lung Cancer After Failure or Intolerability to Second-line Standard Treatment

简要概况

To assess the effectiveness and safety of utidelone injection in patients with advanced or metastatic NSCLC as a phase II trial

详细说明

研究类型 ^ICMJE

Interventional

研究阶段

Phase 2

研究设计 ^ICMJE

分配:
干预模型: Single Group Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Drug: utidelone injection
utidelone monotherapy in patients with advanced NSCLC by utidelone

研究工具

Experimental: utidelone
Utidelone Injection: 30 mg/m2/day, IV on day 1-day 5 of each 21 day cycle, administered to enrolled patients with advanced NSCLC

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

December 31, 2019

预计主要完成日期

October 31, 2019 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: 1. Histologically or cytologically confirmed non-small cell lung cancer 2. NSCLC patients who are not suitable for surgery or radical radiotherapy or chemotherapy, or who have failed to or are intolerable for standard treatment in local advanced or metastatic NSCLC; 3. NSCLC patients failed or intolerable to previous standard second-line treatment (including platinum chemotherapy or targeted therapy); 4. Patients who did not receive chemotherapy, radiotherapy, surgical therapy, molecularly targeted drug therapy, or immunotherapy 4 weeks prior to enrollment; 5. Age 18 -70 years old, ECOG performance status of 0-1; Life expectancy of 3 months or more; 6. Patients must have measurable disease, defined as at least one target lesion that can be accurately measured by imaging techniques in at least one dimension as ≥20 mm with conventional computed tomography (CT), ≥10 mm with spiral CT scan (≥15mm for lymph node) within 3 weeks before enrolment; 7. Patients with no brain metastases or with brain metastases but are stable for more than 4 weeks after treatment; 8. Peripheral neuropathy (PN)

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：70 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

China

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

，

研究赞助商 ^ICMJE

Beijing Biostar Technologies, Ltd

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: YUANKAI SHI, MD, PhD National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China

PRS 账户

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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