临床试验/NCT01449357

NCT01449357撤回2 期

A Single-arm Phase II Trial Investigating the Efficacy and Safety of Zalutumumab in Patients With Non-Small Cell Lung Cancer Who Have Progressive Disease After Treatment With Tyrosine Kinase Inhibitors

Genmab0 个研究点开始时间: 2011年10月10日最近更新: 2011年10月10日

适应症

干预措施

试验速览

阶段: 2 期
状态: 撤回
发起方: Genmab
主要终点: Objective Response (OR) defined as complete response (CR) or partial response (PR) according to the RECIST criteria (revised version 1.1) within 6 months.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

A Single-arm Phase II Trial Investigating the Efficacy and Safety of Zalutumumab in Patients with Non-Small Cell Lung Cancer who have Progressive Disease after Treatment with Tyrosine Kinase Inhibitors.

研究设计

研究类型: Interventional
分配方式: Non Randomized
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 documented disease progression after TKI treatment (verified by CT scan and/or MRI according to RECIST).

排除标准

•Estimated life expectancy of less than 3 months.
•Received the following treatments within 2 weeks prior to Visit 2:
•Cytotoxic or cytostatic anti-cancer chemotherapy
•Total resection or irradiation of the target lesion
•Any investigational agent

研究组 & 干预措施

zalutumumab

Experimental

干预措施: zalutumumab (Drug)

结局指标

主要结局

Objective Response (OR) defined as complete response (CR) or partial response (PR) according to the RECIST criteria (revised version 1.1) within 6 months.

时间窗: within 6 months

次要结局

Disease Control defined as CR, PR or Stable Disease (SD) according to the RECIST criteria (revised version 1.1) within 6 months.(within 6 months)

研究者

发起方

Genmab

申办方类型

Industry

责任方

Sponsor

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