A Retrospective Study of the Efficacy and Safety of Lolatinib in Anaplastic Lymphoma Kinase (ALK) - Positive Non-Small Cell Lung Cancer (NSCLC) Patients With Brain or Meningeal Metastasis
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
This study was a retrospective observational study. The study included patients with non-small cell lung cancer with ALK-fusion brain metastases or meningeal metastases who received first-line and late-line treatment with the third-generation ALK TKI lorlatinib between June 2022 and June 2023.
Data were collected from the electronic medical records database and hospital information system of many hospitals in Sichuan Province. Clinical pathology features including gender, age, ALK mutation status at diagnosis, and clinical stage at diagnosis were collected from the medical records. The physical condition assessed by ECOG-PS before the administration of lorlatinib was recorded. Information on anti-tumor therapy was obtained from the records, including dose and time of ALK-TKI therapy and tumor response, number of prior systemic therapy lines, drug regimen, efficacy, and whether local therapy such as radiotherapy and surgery had been received. In this study, the sample size is not limited, and information is collected according to the maximum number of patients. The study period was from 01 July 2023 to 30 June 2024.
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
- •Age ≥18 years
- •Diagnosis of advanced NSCLC with clear pathology and brain metastases confirmed by MRI or CT scan of the brain or meningeal metastases confirmed by imaging or lumbar puncture cerebrospinal fluid cytology
- •ALK fusion mutation confirmed by tumor histology or hematology
- •Treatment with lorlatinib from June 2022 to June 2023
- •Survival greater than 12 weeks
排除标准
- •Patients treated with lorlatinib for less than 4 weeks
研究组 & 干预措施
Advanced ALK+ NSCLC Patients with Brain or Meningeal Metastasis
干预措施: Lorlatinib (Drug)
结局指标
主要结局
ORR
时间窗: From date of receiving therapy until date of disease progression or the end of study, whichever came first, assessed up to 24 months.
the Sum of percentage of participants with CR and PR as assessed by RECIST v1.1 or RANO-BM criteria every 8-12 weeks.
次要结局
- OS(From date of receiving therapy until date of disease progression or death, whichever came first, assessed up to approximately 24 months.)
- PFS(From date of receiving therapy until date of disease progression or death, whichever came first, up to approximately 24 months.)
- AE(From date of receiving therapy until date of disease progression or death or the end of study, assessed up to approximately 24 months.)
研究者
Juan LI, MD
Principal Investigator
Sichuan Cancer Hospital and Research Institute
