Lung Cancer
Conditions
Interventions
Treatment-naive EGFR-mutated NSCLC with brain metastases:Furmonertinib 160mg, po, qd
Treated with first or second generation EGFR TKI therapy NSCLC with brain metastases:Furmonertinib 80mg, po, qd
Treated with third generation EGFR TKI therapy NSCLC with brain metastases:Furmonertinib 160mg, po, qd
EGFR-mutated NSCLC with Leptomeningeal metastases:Furmonertinib 160mg, po, qd combined with intrathecal injection MTX or MTA
Sponsors
Beijing Tiantan Hospital,Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Male or Female aged =18 and =75 years old; 2.Being able to understand and voluntarily participate in the study, and sign the informed consent form, with good compliance and for follow-up; 3.Histologically or cytopathologically confirmed non-small cell lung cancer (NSCLC) ; Tumor tissue samples or blood samples are confirmed to be EGFR mutations (including 19del ?21L858R ?T790M? G719X?L861Q?S768I); 4.ECOG PS 0-2, Life expectancy >12 weeks; 5.Adequate organ function, including: NE=1.5×109 /L, PLT=75×109/L, HGB=80 g/L;TBIL=1.5 times ULN, AST and ALT=2.5 times ULN (with liver metastasis, AST and ALT=5 times ULN), Cr=1.5×ULN, CrCL =50 mL /min (according to Cockcroft-Gault formula); 6. Patients must take effective contraceptive measures during the study and and within 3 months after drug discontinuation.
Exclusion criteria
Exclusion criteria: 1.Having received the following therapies:Having received major surgery within 4 weeks prior to the first dose of investigational product or plan to receive major surgery during the study with exception of the surgical procedures to establish vascular access, biopsy through mediastinoscopy or thoracoscopy; Having participated in the clinical trial and received the investigational product or device within 4 weeks or at least 5 half-lives prior to the first dose of investigational product; Having been irradiated for >30% bone marrow or a large area within 4 weeks prior to the first dose of investigational product; 2.Use of a potent CYP3A4 inhibitor within 7 days prior to the first dose of investigational product or a potent CYP3A4 inducer within 21 days prior to the first dose of investigational product; use of the traditional Chinese medicine or traditional Chinese medicine preparation with tumor indication, or traditional Chinese medicine or traditional Chinese medicine preparation with adjuvant anti-tumor effect within two weeks prior to the first dose of investigational product or expected to be required during the study; 3.The toxicity caused by previous anti-tumor therapy >CTCAE grade 1 (CTCAE 5.0) ( except alopecia,) and neurotoxicity caused by previous platinum-related therapy >CTCAE grade 2(CTCAE 5.0); 4.Any clinical evidence suggestive of severe or uncontrolled systemic illness, such as uncontrolled hypertension, uncontrolled diabetes, coronary stenosis, aortic dissection, aortic aneurysm, or active susceptible bleeding entities, active hepatitis B virus (HBV DNA quantification = 1000cps/ mL), hepatitis C virus (positive HCV Ab) or human immunodeficiency virus (positive HIV antibody) infection, which were considered by the investigator to be inappropriate for trial participation or that would affect adherence to the protocol; 5.Serious gastrointestinal dysfunction, or disease that may affect the intake, transportation or absorption of investigational product; 6.Any of the following cardiac criteria: QTc>470 ms on ECG at resting state, when the first abnormality occurs, the test is repeated 2 times within 48h, and the average result of 3 times is calculated; Various clinically significant abnormalities in rhythm, conduction, and resting ECG patterns, such as complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block, PR interval >250msec, etc; Factors that may increase the risk of QTc prolongation or the risk of arrhythmic events; LVEF<50%; 7.Other conditions that are considered by investigators as unsuitable to participate in this study; 8.Known or suspected allergy to Furmonertinib or other components of its preparation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Central nervous system progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Central nervous system objective response rate;Central nervous system disease control rate;PFS;OS;DOR;TTR; | — |
Countries
China
Contacts
Public ContactXiaoyan Li
Beijing Tiantan Hospital,Capital Medical University
Outcome results
None listed