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
- 试验地点
- 8
- 主要终点
- Number frequency and proportion of patients with adverse events (AEs) serious adverse events (SAEs) and AEs of special interest (AESI) including interstitial lung disease or pneumonitis like events and on study deaths
研究概览
简要总结
This is a prospective, single-arm, multicenter, phase-IV trial investigating the safety of osimertinib in Indian adult patients with locally advanced or metastatic EGFR-T790M mutation-positive NSCLC. Investigator will be trained on the locally approved prescribing information before the enrolment of the first patient at their site to ensure compliant and proper dosing of the study drug. Patients will be monitored throughout the study period for AEs of osimertinib.
The decision of patients to participate in this study must not, in any way, impact upon the standard of care that they are receiving or any benefits to which they are otherwise entitled. Prior to data collection, all patients must sign an informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements and sponsor policy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
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.
结局指标
主要结局
Number frequency and proportion of patients with adverse events (AEs) serious adverse events (SAEs) and AEs of special interest (AESI) including interstitial lung disease or pneumonitis like events and on study deaths
时间窗: NA
次要结局
- NA(NA)