A Real-World Clinical Retrospective Study of Firmonertinib in the Treatment of EGFR(+) NSCLC Patients With Central Nervous System Metastasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- iPFS
研究概览
简要总结
This is a clinical retrospective study that will collect and analyze clinical data from all patients treated with fumeitinib mesylate in the Oncology Department of Tiantan Hospital between January 1, 2020 and May 31, 2025. The data collection will include general demographic characteristics (gender, age, family history, smoking history, etc.), clinicopathological features, NGS test reports, fumeitinib initiation time and dosage, concomitant medications, local treatments (surgery, radiotherapy, etc.), and baseline and follow-up imaging examinations related to efficacy and safety. The study will conduct: 1) clinical data analysis; and 2) exploration of resistance-related clinical characteristics and influencing factors.
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
- •Histologically or cytologically confirmed stage IIIb-IVb NSCLC or postoperative recurrent NSCLC;
- •Positive EGFR test result, which can be determined by methods such as RT-PCR/FISH/IHC/NGS from hospital laboratories or testing institutions;
- •Patients aged ≥18 years;
- •Patients have clinically received Firmonertinib treatment, with recorded objective efficacy evaluation and adverse reactions;
- •Sign the Beijing Tiantan Hospital broad informed consent form.
排除标准
- •- Patients who cannot provide follow-up data for at least one cycle.
研究组 & 干预措施
EGFR-mutated NSCLC with brain metastases
干预措施: Firmonertinib (Drug)
EGFR-mutated NSCLC with leptomeningeal metastases
干预措施: Firmonertinib (Drug)
结局指标
主要结局
iPFS
时间窗: From first dose until the event of interest, assessed between January 1, 2020 and May 30, 2025
According to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) and the Response Assessment in Neuro-Oncology (RANO) criteria, the intracranial progression-free survival (iPFS) of Firmonertinib in subjects with advanced non-small cell lung cancer (NSCLC) with central nervous system (CNS) metastases and EGFR mutation-positive status will be evaluated separately for different cohorts
次要结局
- PFS(From first dose until the event of interest, assessed between January 1, 2020 and May 30, 2025)
- OS(From first dose until death, assessed between January 1, 2020 and May 30, 2025)
- iDCR(Within the study period from January 1, 2020 and May 30, 2025)
- DOR(Within the study period from January 1, 2020 and May 30, 2025)
- TTR(assessed during the study period from January 1, 2020 and May 30, 2025.)