Leptomeningeal metastases patients with EGFR mutation-positive NSCLC
Conditions
Interventions
The observation group of EGFR-mutant non-small cell lung cancer with perivascular membrane metastasis:None
Sponsors
Nanjing Brain Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old. 2. Histological or cytological diagnosis of NSCLC with EGFR sensitive mutations (including L858R and/or Exon19Del). 3. Comprehensive clinical assessment based on the "EANO-ESMO" diagnostic criteria for leptomeningeal metastasis. The subjects with confirmed leptomeningeal metastasis have comprehensive clinical assessment contents including symptom assessment, imaging assessment, and/or cerebrospinal fluid pathological assessment. 4. After the progression of leptomeningeal disease occurs following the treatment with third-generation EGFR-TKIs, the medical record confirms that the patient has received sotorasib treatment (since March 1, 2025 and thereafter). 5. There must be at least one follow-up record after the administration of sotorasib. 6. The patient must sign the informed consent form (ICF) of this study, or have the ICF exemption approved by the ethics review committee.
Exclusion criteria
Exclusion criteria: 1.Concurrent enrollment in an interventional clinical trial during zorifertinib therapy. 2.Other active malignancies requiring concurrent therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Real-World Time to Treatment Discontinuation (rwTTD); | — |
Secondary
| Measure | Time frame |
|---|---|
| Actual life expectancy in the real world;Overall objective response rate in the real world;Overall progression-free survival in the real world;Improvement in central nervous system symptoms;Change in KPS score;Progression-free survival of the real-world periventricular meninges;Safety Parameters;Intracranial progression-free survival in the real world; | — |
Countries
China
Contacts
Public ContactFang Shencun
Nanjing Brain Hospital
Outcome results
None listed