CTRI/2018/10/015941已完成4 期
A prospective, multicenter, Phase-IV clinical trial to assess safety ofTAGRISSO (Osimertinib) in Indian adult patients with metastaticepidermal growth factor receptor (EGFR) T790M mutation-positivenonsmall cell lung cancer (NSCLC)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1 Patient of either sex and >=18 years of age
- •2 Patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an appropriate test, who have progressed on or after EGFR TKI therapy by an independent clinical judgment of treating physician based on locally approved prescribing information
- •3 Each patient (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. Patients must be willing and able to adhere to the prohibitions and restrictions specified in this protocol, as referenced in the informed consent form (ICF).
排除标准
- •Patient with either the history of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug.
- •2 Pregnant and/or lactating women
- •3 Patients participating in any current or future interventional trial will not be enrolled in the current study
研究者
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