Leptomeningeal Metastasis in EGFR-Mutant Non-Small Cell Lung Cancer
Conditions
Interventions
Research group:intrathecal Ivonescimab
Sponsors
The First Af?liated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1: Subjects voluntarily participate in this study, sign the informed consent form, and have good compliance. 2: Male or female aged >=18 years. 3: Subjects are histologically / cytologically confirmed with NSCLC, cerebrospinal fluid cytology and/or have typical clinical symptoms and positive imaging, diagnosed with LM according to the European Neuro-Oncology Association-European Society of Medical Oncology (EANO-ESMO) guideline criteria, and genetic testing suggests EGFR mutations. 4: Hemoglobin >=90g/L; Absolute neutrophil count>=1.5×10^9/L; Platelets>=100×10^9/L. 5: ALT and AST=50mL/min; Proteinuria =2+, 24-hour urine protein quantification should be performed, and <=1g can be selected). 6: Activated partial thromboplastin time (APTT) <=1.5 × ULN, international normalized ratio (INR) <= 1.5 × ULN.
Exclusion criteria
Exclusion criteria: 1. Known history of contraindications and allergies to any component of ivocimab in the past; 2. Presence of active central nervous system infection or meningitis; 3. Have other systemic primary active malignancies other than NSCLC; 4. Active autoimmune disease requiring systemic treatment or history of autoimmune disease within 2 years prior to the first dose; 5. Serious systemic infection within 28 days prior to the first dose, active infection requiring intravenous or oral antibiotic therapy within 14 days prior to the first dose; 6. Adverse reactions of previous anti-tumor therapy have not recovered to NCI-CTCAE 5.0 grade evaluation =2000 IU/ml; Hepatitis C reference: HCV antibody positive and HCV virus copy number >upper limit of normal); 13. Have unwell-controlled cardiac clinical symptoms or diseases, such as: (1) Cardiac insufficiency of class II or above according to New York Heart Association (NYHA) criteria or color Doppler echocardiography: LVEF (left ventricular ejection fraction) 450ms (male) QTc> 470 ms (female); 14. Patients are known to have a history of psychotropic substance abuse, alcoholism, or drug abuse; Have a definite prior neurological or psychiatric predecessor History of disorders, including epilepsy or dementia or hepatic encephalopathy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose;Dose-limiting toxicity;Adverse event incidence; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;OS;PFS; | — |
Countries
China
Contacts
Public ContactJianjun Jin
The First Af?liated Hospital of Zhengzhou University
Outcome results
None listed