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临床试验/NCT01990261
NCT01990261终止不适用

The Survival of Non-Small Cell Lung Carcinoma EGFR Non-mutated (Wild Type) Patients Treated With Erlotinib (TARceva) After the Failure of at Least One Chemotherapy Regimen

Hoffmann-La Roche0 个研究点目标入组 33 人开始时间: 2013年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
33
主要终点
Survival Rate at Month 6

研究概览

简要总结

This study will evaluate the survival of non-small cell lung cancer (wild-type EGFR) participants treated with Tarceva after at least one failed chemotherapy treatment, and the impact of prior chemotherapy treatments.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults >/= 18 years
  • Histologically documented locally advanced, metastatic, or recurrent non-small cell lung carcinoma with wild-type EGFR eligible for Tarceva treatment.
  • At least one failed chemotherapy treatment.

排除标准

  • Unknown EGFR mutation status

研究组 & 干预措施

Erlotinib

Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.

干预措施: Erlotinib (Drug)

结局指标

主要结局

Survival Rate at Month 6

时间窗: Month 6

Survival Rate at Month 12

时间窗: Month 12

Progression Free Survival (PFS) at Month 6

时间窗: From inclusion up to disease progression or death whichever occurs first (up to 6 months)

PFS is defined as the time from inclusion in the study to the disease progression or death whichever occurs first. Disease progression was determined according to local treatment guidelines.

Progression Free Survival (PFS) at Month 12

时间窗: From inclusion up to disease progression or death whichever occurs first (up to 12 months)

PFS is defined as the time from inclusion in the study to the disease progression or death whichever occurs first. Disease progression was determined according to local treatment guidelines.

次要结局

  • Overall Survival (OS)(Up to 12 months)
  • Percentage of Participants With Adverse Events (AEs)(Up to 12 months)
  • Overall Survival According to Prior Chemotherapy Treatment.(Up to 12 months)

研究者

申办方类型
Industry
责任方
Sponsor

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