Non-Small Cell Lung Cancer (NSCLC) with EGFR Mutation and Leptomeningeal Metastasis
Conditions
Interventions
Experimental Group:Limeritinib, 160mg, twice a day
Sponsors
HenanCancerHospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.The patient voluntarily enrolled in this study, signed the informed consent form, and demonstrated good compliance. 2.The patient has reached the age of 18. 3.ECOG Performance Status: 0-3; 4.Histologically or cytologically confirmed, unresectable (not amenable to complete surgical resection) and not eligible for curative radiotherapy locally advanced or metastatic non-small cell lung cancer (including patients with recurrence after prior surgical treatment or newly diagnosed stage IIIb, IIIc, or IV disease, staged according to AJCC 8th Edition); 5.The pathological report confirms the presence of one of the two common EGFR-positive gene mutations sensitive to EGFR-TKI therapy, namely exon 19 deletion or exon 21 L858R substitution. These mutations may exist alone or in combination with other EGFR site mutations. 6.Both patients with initial leptomeningeal metastasis and those who developed leptomeningeal metastasis after EGFR-TKI therapy are eligible. 7.Laboratory tests must meet the following criteria (within 28 days prior to enrollment at baseline): (1) Complete Blood Count: a. Hemoglobin (Hb) >= 90 g/L (no blood transfusion within 28 days); b. Absolute Neutrophil Count (NEUT) >= 1.5 × 10^9/L; c. Platelets (PLT) >= 75 × 10^9/L; d. White Blood Cell Count (WBC) >= 3 × 10^9/L; (2) Biochemical Tests: a. Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) <= 2.5 × ULN (Upper Limit of Normal); b. Total Bilirubin (TBIL) <= 1.5 × ULN; 8.Female subjects must agree to use contraceptive measures (such as an intrauterine device [IUD], oral contraceptives, or condoms) during the study and for 6 months after the study concludes; male subjects must agree to use contraceptive measures during the study and for 6 months after the study concludes.
Exclusion criteria
Exclusion criteria: 1.Clinically significant gastrointestinal abnormalities that may affect the intake, transport, or absorption of the investigational agent, such as inability to take oral medication, uncontrollable nausea or vomiting, extensive gastrointestinal resection history, unresolved chronic diarrhea, Crohn's disease, or ulcerative colitis. 2.Radiation pneumonitis requiring steroid therapy, or clinically active interstitial lung disease (ILD) with documented evidence. 3.Concurrent other malignant tumors, with the exception of adequately treated basal cell carcinoma of the skin or papillary thyroid cancer. 4.Subjects with any factors affecting oral drug administration (such as inability to swallow, history of gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.). 5.History of allergy to pemetrexed-based systemic chemotherapy. 6.Patients with any signs or history of bleeding diathesis, regardless of severity; or patients with any hemorrhagic events >= CTCAE Grade 3 within 4 weeks prior to the first dose; 7.Patients with any severe and/or uncontrolled medical conditions, including: (1)Acute or ongoing myocardial ischemia or myocardial infarction, poorly controlled and clinically significant arrhythmias; (2) Active or uncontrolled severe infection (>= CTCAE Grade 2 infection); (3)Positive HIV test; (4)Urinalysis showing urine protein >= 2+, and confirmed 24-hour urine protein quantification > 1.0 g. 8.Patients who have received preventive or live attenuated vaccines within 4 weeks prior to the first dose. 9.Subjects who, in the investigator's judgment, have any other factors that could lead to premature discontinuation of the study, such as other severe diseases (including mental disorders) requiring concomitant therapy, significant laboratory abnormalities, or familial/social circumstances that may compromise subject safety or data collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival,OS; | — |
Countries
China
Contacts
Public ContactLiu Jie
HenanCancerHospital
Outcome results
None listed