advanced non-small cell lung cancer with epidermal growth factor receptor gene mutation and leptomeningeal metastasis
Conditions
Interventions
Furmonertinib group:Furmonertinib oral 240mg/d
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria can be enrolled in this trial: 1) Written informed consent has been obtained from the patient or his or her legal representative; 2) Patients =18 years old, male or female; 3) Non-small cell lung cancer diagnosed by histological or cytological pathology; 4) Genetic testing confirmed EGFR positive for classical or non-classical mutations; 5) Patients with definite meningeal metastases diagnosed by the investigators according to the "EANO-ESMO" criteria for the diagnosis of meningeal metastases, with a comprehensive clinical evaluation including symptom assessment, imaging, and/or cerebrospinal fluid pathology; 6) Patients with primary treatment of meningeal metastases as well as those who are eligible for Furmonertinib treatment after disease progression on standard antitumor therapy in prior clinical practice. It can be enrolled and received furmonertinib mesylate tablets 240mg once a day; 7) Prior treatment with radiation or surgery targeting the central nervous system is allowed; 8) Patients with CNS symptoms or signs that are not life threatening are admitted; 9) Fertile men or women who have the possibility of becoming pregnant must use a highly effective contraceptive method during the trial (such as oral contraceptives, intrauterine devices, controlled sexual desire or barrier contraception combined with spermicide) and continue to use contraception for 12 months after the end of treatment.
Exclusion criteria
Exclusion criteria: Patients meeting the following conditions will not be enrolled in this trial 1) Currently complicated with tumors other than NSCLC; 2) Developing or having a history of other malignant tumors within the last 5 years, except for basal cell carcinoma of the skin, carcinoma in situ of the cervix and ductal carcinoma in situ of the breast, which have been effectively controlled; 3) There are serious digestive tract diseases that affect drug administration and absorption, including but not limited to peptic ulcer and inflammatory bowel disease. 4) Evidence of any severe or uncontrolled systemic disease, including uncontrolled hypertension, diabetes, and active bleeding, that the investigator considers to be detrimental to patient participation in the study or to adherence to the protocol, or active infections including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV); 5) History of interstitial lung disease, drug-induced interstitial lung disease, prior history of radiation pneumonia requiring steroid treatment, or any evidence of active interstitial lung disease; 6) Significant arrhythmias (e.g. QT prolongation > 500ms) or heart failure (left ventricular ejection fraction < 50%) 7) Pregnant or lactating women; 8) Patients who received live vaccine within 4 weeks prior to the start of treatment; 9) Patients who are currently or have participated in other clinical studies within 4 weeks; 10) Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that, according to the investigator, may increase the risks associated with study participation or may interfere with the interpretation of the study results; Or subjects who are not necessarily able to complete the study or comply with the requirements of the study (for administrative or other reasons).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival(OS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Treatment Discontinuation (TTD);Symptom improvement rate; | — |
Countries
China
Contacts
Public ContactQiming Wang
The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Outcome results
None listed