Inclusion Criteria:
1. Male or Female aged ≥18 years old;
2. ECOG PS 0-2;
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 or 21L858R or T790M);
4. Patients with brain metastases treatment-naïve, or treated with EGFR TKI intracranial
progression alone without significant associated symptoms, or intolerance to EGFR TKI
treatment(including Gefitinib, Erlotinib, Icotinib, Afatinib, Dacomitinib,
Osimertinib, Almonertinib), or intracranial progression after brain radiotherapy；
5. Life expectancy >3 months;
6. Subjects with asymptomatic meningeal metastases can be enrolled, prior corticosteroid
use allowed; Subjects requiring corticosteroids during the study are excluded;
7. According to RECIST1.1, the subject has at least 1 intracranial measurable lesion;
8. Adequate organ function (28 days before enrollment), including:
1)Blood routine examination HB≥90 g/L（No blood transfusion within 14 days prior to
enrollment） ANC≥1.5×109 /L PLT≥100×109 /L 2)Biochemical examination TBIL≤1.5 times ULN AST
and ALT≤2.5 times ULN (with liver metastasis, AST and ALT≤5 times ULN) Cr≤1×ULN，CrCL ≥50 mL
/min (according to Cockcroft-Gault formula) PT/INR≤1.5 times ULN; aPTT≤1.5 times ULN (If
the subject is receiving anticoagulation, PT or aPTT is within the therapeutic range
expected for anticoagulant use) 9.No systemic corticosteroid therapy within 4 weeks prior
to treatment; 10.Males of reproductive potential or females of potential pregnancy must
take effective contraceptive measures (eg, oral contraceptives, intrauterine devices,
abstinence or barrier contraception combined with spermicide) during the study and and
within 12 months after drug discontinuation; 11.Being able to understand and voluntarily
participate in the study, and sign the informed consent form, with good compliance and for
follow-up.
Exclusion Criteria:
1.Male or Female aged ≥18 years old; 2.ECOG PS 0-2; 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 or 21L858R or T790M); 4.Patients with brain
metastases treatment-naïve, or treated with EGFR TKI intracranial progression alone without
significant associated symptoms, or intolerance to EGFR TKI treatment(including Gefitinib,
Erlotinib, Icotinib, Afatinib, Dacomitinib, Osimertinib, Almonertinib), or intracranial
progression after brain radiotherapy； 5.Life expectancy >3 months; 6.Subjects with
asymptomatic meningeal metastases can be enrolled, prior corticosteroid use allowed;
Subjects requiring corticosteroids during the study are excluded; 7.According to RECIST1.1,
the subject has at least 1 intracranial measurable lesion; 8.Adequate organ function (28
days before enrollment), including:
1. Blood routine examination HB≥90 g/L（No blood transfusion within 14 days prior to
enrollment） ANC≥1.5×109 /L PLT≥100×109 /L. 2. Biochemical examination TBIL≤1.5 times ULN AST and ALT≤2.5 times ULN (with liver
metastasis, AST and ALT≤5 times ULN) Cr≤1×ULN，CrCL ≥50 mL /min (according to
Cockcroft-Gault formula) PT/INR≤1.5 times ULN; aPTT≤1.5 times ULN (If the subject is
receiving anticoagulation, PT or aPTT is within the therapeutic range expected for
anticoagulant use) 9.No systemic corticosteroid therapy within 4 weeks prior to
treatment; 10.Males of reproductive potential or females of potential pregnancy must
take effective contraceptive measures (eg, oral contraceptives, intrauterine devices,
abstinence or barrier contraception combined with spermicide) during the study and and
within 12 months after drug discontinuation; 11.Being able to understand and
voluntarily participate in the study, and sign the informed consent form, with good
compliance and for follow-up.
Exclusion Criteria:
1.Known or suspected allergy to Furmonertinib or other components; 2.With EGFR Ex20ins
mutation; 3.Treated more than one EGFR-TKI (excluding Patients with T790M mutation use
Osimertinib or Almonertinib only intracranial progression after prior first/second
generation EGFR-TKI resistance ) , chemotherapy more than one line (excluding change of
medication due to adverse events or maintenance treatment); 4.Subjects who have received
other anti-tumor therapy within four weeks prior to the first dose of the study or who have
failed to recover (≤ grade 1) from an adverse event resulting from prior treatment; 5.Any
of the following cardiac criteria:
1. 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.
2. 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.
3. Factors that may increase the risk of QTc prolongation or the risk of arrhythmic
events.
6.Pregnant or breastfeeding women; 7.Known hepatitis C virus (positive HCV Ab) or human
immunodeficiency virus (positive HIV antibody) infection, positive HBsAg or HBCAb with
positive HBV DNA copy number (>500 IU/ml); 8.Previous interstitial lung disease (ILD);
9.Having severe or uncontrolled systemic disease, including active opportunistic infection
or progressive (severe) infection, uncontrolled diabetes, cardiovascular disease (III or IV
heart failure by NYHA Functional Classification, second degree or greater atrioventricular
block, myocardial infarction or unstable arrhythmia or unstable angina within the past 6
months, cerebral infarction within 3 months, etc.), pulmonary disease (interstitial
pneumonia, obstructive pulmonary disease and history of symptomatic bronchospasm);
10.Meningeal metastases with CNS symptoms may be enrolled if the subject's intracranial
metastases can be adequately treated and CNS symptoms can be restored to a level less than
or equal to CTCAE1 and remain stable prior to enrollment; 11.Received a live vaccination
within 4 weeks prior to the start of study treatment; 12.Major surgery (excluding
diagnostic surgery) within 4 weeks prior to the start of treatment; 13.Known history of
mental disease or drug abuse, and currently having an attack or still taking drugs;
14.Serious gastrointestinal dysfunction, or disease that may affect the intake,
transportation or absorption of investigational product; 15.History of other malignant
tumors within 3 years, except for cured basal cell carcinoma and cervical carcinoma in
situ; 16.According to the investigators, subjects with other serious acute or chronic
disease, mental disease , laboratory abnormalities that may increase the risk or interfere
with the interpretation of study results are excluded; 17.Subjects who are or have been
involved in other clinical studies within 4 weeks; 18.According to the investigator,
subjects may not complete this study or may not comply with the requirements of this study.
