Real World Evaluation of Sotorasib Among Chinese Non-Small Cell Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Amgen
- 入组人数
- 115
- 试验地点
- 3
- 主要终点
- Number of Participants with Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
The primary objective of this study is to characterize the safety profile of sotorasib.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Adult (≥ 18 years) as of the index date.
- •KRAS p.G12C-mutated locally advanced or metastatic NSCLC.
- •Received at least 1 dose of sotorasib.
- •Receipt of at least 1 prior systemic therapy before use of sotorasib.
- •Obtained ICF, if required.
排除标准
- •Documentation of being a non-Chinese ethnicity.
研究组 & 干预措施
Chinese Participants Treated with Sotorasib
Adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS) p.G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) and previously treated with at least 1 prior systemic therapy that have received sotorasib treatment in either location of BOAO Pilot Zone and Hong Kong SAR will be included in this cohort.
The duration of evidence collection is from initiation of sotorasib to the end of study period, up to approximately 4 years from the date of the first available sotorasib use in BOAO Pilot Zone of around August 2021.
干预措施: Sotorasib (Drug)
结局指标
主要结局
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
时间窗: Up to approximately 4 years
Number of Participants with Adverse Events of Interest, Inclusive of Hepatotoxicity, Interstitial Lung Disease/Pneumonitis, and Renal Toxicity
时间窗: Up to approximately 4 years
Number of Participants with Treatment-related Adverse Events (AEs)
时间窗: Up to approximately 4 years
Number of Participants with Treatment-related AEs of Grade 3 or Worse
时间窗: Up to approximately 4 years
Number of Participants with Serious Treatment-related AEs
时间窗: Up to approximately 4 years
Number of Participants with Treatment-related AEs Leading to Treatment Discontinuation
时间窗: Up to approximately 4 years
Number of Participants with Treatment-related AEs Leading to Dose Reduction
时间窗: Up to approximately 4 years
Number of Participants with Treatment-related AEs Leading to Death
时间窗: Up to approximately 4 years
次要结局
- Overall Survival (OS) from Initial Date of Sotorasib Use to Date of Death(Up to approximately 4 years)