Non-small cell lung cancer
Conditions
Interventions
Queue A:Limerinib Tablets, Pemetros
Queue 2:Limerinib Tablets
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Sign a written informed consent before implementing any test-related processes; 2. Age >=18 years old; 3. Local advanced or metastatic non-small cell lung cancer with meningeal metastasis confirmed by tissue or cell pathology, which cannot be completely removed by surgery and cannot be cured by radiotherapy; 4. EGFR-sensitive mutations (Ex19del, L858R, G719X, S768I, L861Q, E709X) have been confirmed by tumor histology or cytology or hematology; 5. ECOG score is 0-1; 6. Expected survival time >3 months; 7. With sufficient organ function, the subjects need to meet the following laboratory indicators: 1) Under the condition of not using the granulocyte settlement stimulating factor in the past 14 days, the absolute value of neutrophils (ANC) >=1.5x109/L; 2) In the absence of blood transfusion in the past 14 days, platelets >=100×10^9/L; 3 ) In the past 14 days without blood transfusion or the use of erythropoietin, hemoglobin >9g/dL; 4) Total bilirubin =60 ml/min; 7) Good coagulation function, defined as internationally standardized ratio ( INR) or prothrombin time (PT) <=1.5 times ULN; 8) normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be included in the group; 9) The myocardial enzyme spectrum is within the normal range (if the researcher's comprehensive judgment of simple laboratory abnormalities that have no clinical significance are also allowed to be included in the group); 8. For female subjects of childbearing age, they should undergo a urine or serum pregnancy test within 3 days before the first study drug administration (the first day of the first cycle) and the result is negative. If the urine pregnancy test result cannot be confirmed to be negative, a blood pregnancy test is required. Women of non-fertile age are defined as at least 1 year after menopause, or have undergone surgical sterilization or hysterectomy; if there is a risk of conception, all subjects (whether male or female) need to use it within the entire treatment period until 120 days after the administration of the last study drug (or 180 days after the administration of the last study drug) Contraceptive measures with an annual failure rate of less than 1%.
Exclusion criteria
Exclusion criteria: 1. The pathology is small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC; 2. Those who are known to be allergic to the active ingredients or auxiliaries of the drug leitinin in this study; 3. Before the start of treatment, have not fully recovered from the toxicity and/or complications caused by any intervention (i.e., =1 or reach the baseline, excluding fatigue or hair loss); 4. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); 5. Untreated active hepatitis B (defined as HBsAg positive and the number of HBV-DNA copies detected is greater than the upper limit of the normal value of the laboratory of the research center); Note: Hepatitis B subjects who meet the following criteria can also be included in the group: 1) HBV virus load <1000 copies/ml before the first administration ( 200 IU/ml), subjects should receive anti-HBV treatment throughout the study drug treatment to avoid virus reactivation 2) Subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-) do not need to undergo preventive anti-HBV treatment , but the virus needs to be closely monitored and activated again. 6. Active HCV-infected subjects (HCV antibody positive and HCV-RNA level is higher than the lower test limit); 7. Have been vaccinated with a live vaccine within 30 days before the first administration (cycle 1, day 1); Note: It is allowed to receive an inactivated virus vaccine against seasonal influenza within 30 days before the first administration; but it is not allowed to receive live attenuated live influenza vaccine for intranasal administration. 8. Pregnant or lactating women; 9. It is possible to interfere with the test results, hinder the subject's participation in the whole process of the study, medical history or disease evidence, abnormal treatment or laboratory test values, or other circumstances that the researcher believes that are not suitable for the group. The researcher believes that there are other potential risks that are not suitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total survival period;Intracranial progression-free survival;Safety and tolerance;Remission of meningeal metastasis; | — |
Countries
China
Contacts
Public ContactYan Ningning
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed