EGFR mutated NSCLC with Leptomeningeal Metastasis
Conditions
Interventions
Experimental Group:Treatment with vormetinib
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. NSCLC patients diagnosed by tissue or cell pathology; 2.EGFR exon 19 deletion or exon 21 L858R mutant type; 3. Confirmed as meningeal metastasis by positive cerebrospinal fluid cytology (up to 28 days before the first administration) and with >=1 meningeal metastasis lesion that can be repeatedly evaluated by MRI; 4. Progression after first-line TKI treatment; 5. Age >=18 years old and =1.5×10^9/L, platelet count >=75×10^9/L, hemoglobin >=90g/L; Total bilirubin =50 mL/min (calculated according to the Cockcroft-Gault formula); For patients included in the pharmacokinetic study, it is required that they have not previously received vormetinib treatment (in combination or as a single agent). 8. The patient signs the informed consent form, is willing to accept the treatment plan, can adhere to the medication, and has good compliance.
Exclusion criteria
Exclusion criteria: 1. The baseline assessment form cannot be completed; 2. Combined with severe or uncontrolled systemic diseases, including active infections, electrolyte imbalances, bleeding tendencies, etc. 3. Pregnant and lactating women, or those who plan to become pregnant during the study period and within 6 months after the study ends; 4. There are central nervous system complications that require urgent neurosurgical intervention; 5. Suffering from other malignant tumors or having a history of other malignant tumors; 6. Severe brain diseases or mental disorders that affect the patient's ability to self-report; 7. Those without legal capacity for conduct, or those whose research progress is affected by medical or ethical reasons; 8. Other circumstances determined by the researcher as unsuitable for participation in this study. 9. Patients with severe allergic constitutions, especially those who have experienced severe drug allergies or other serious adverse reactions during previous use of TKIs;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Leptomeningeal metastasis-disease control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life score;Overall survival;Intracranial duration of response;Incidence of adverse events;Cerebrospinal Fluid Penetration Rate;Leptomeningeal metastasis-objective response rate;Neurological function;Progression-free survival;Gene Mutation Status;Intracranial progression-free survival; | — |
Countries
China
Contacts
Public ContactZhang Haibo
Guangdong Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed