跳至主要内容
临床试验/NCT06410040
NCT06410040进行中(未招募)不适用

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

Sichuan Cancer Hospital and Research Institute1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2023年8月20日最近更新:
适应症
干预措施
相关药物

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

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

发起方
Sichuan Cancer Hospital and Research Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Juan LI, MD

Principal Investigator

Sichuan Cancer Hospital and Research Institute

研究点 (1)

Loading locations...

相似试验