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临床试验/NCT03321695
NCT03321695已完成不适用

An Observational Study of the Safety of Atezolizumab in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer in Argentina

Hoffmann-La Roche1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2017年12月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
主要终点
Percentage of Participants With Adverse Events

研究概览

简要总结

This is a study of the safety and effectiveness of atezolizumab in participants with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy. Participants also will have progressed on an appropriate approved targeted therapy if their tumor has epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) gene abnormalities treated in common clinical practice settings in Argentina.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Signed an informed consent form submitted to the Administración Nacional de Medicamentos Alimentos y Tecnología Médica (ANMAT)
  • Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) non-small cell lung cancer (NSCLC)
  • Have received at least one dose of atezolizumab as per local label and clinical practice

排除标准

  • Contraindicated atezolizumab therapy

结局指标

主要结局

Percentage of Participants With Adverse Events

时间窗: Up to approximately 2 years

次要结局

  • Overall Survival (OS)(Up to approximately 2 years)
  • Duration of Response (DOR)(Up to approximately 2 years)
  • Progression-Free Survival (PFS)(Up to approximately 2 years)
  • Percentage of Participants With a Confirmed Objective Response (ORR) of Complete Response (CR) or Partial Response (PR)(Up to approximately 2 years)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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