Almonertinib is a three-generation epidermal growth factor receptor tyrosine kinase inhibitor(EGFR-TKI), which has shown competitive potential in the second-line treatment against first-generation TKIs. This study aims to explore the efficacy and safety of different doses of almonertinib in the first-line and second-line treatment of brain metastases/meningeal metastases in NSCLC patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Patients was given a standard dose of 110mg/day of almonertinib, orally, and the first efficacy evaluation was carried out 4 weeks later. If the patient's lungs and/or other parts of the disease (PD) progress, then leave the group to receive other treatment; if the patient's lungs If the brain and other parts are stable or relieved and the brain has not progressed, continue the original dose treatment, and evaluate the effect every 8 weeks. Until the patient's lungs and/or other parts progress (PD), then leave the group to receive other treatment; if If the patient's lungs and other parts are stable or relieved and the brain is progressing, the dose of almonertinib can be increased to 165mg/day, orally ± radiotherapy (the investigator's decision), and then the efficacy will be evaluated every 8 weeks until the patient's lungs and/ Or there is progress (PD) in other parts, then the group will receive other treatment.
Patients were given a standard dose of almonertinib 110 mg/day, orally, and the first efficacy evaluation was performed 4 weeks later. If there was no disease progression in two consecutive evaluations, the dose of almonertinib was increased to 165 mg /Day, oral ± radiotherapy (decided by the investigator), continue to evaluate the efficacy every 4 weeks until the patient progresses; if there is no disease progression in two consecutive assessments, the dose of almonertinib is increased to 220 mg/day, orally ± Radiotherapy treatment (determined by the investigator), continue to evaluate the efficacy every 4 weeks until the patient progresses.
Henan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGiPFS
Intracranial progression-free survival (iPFS)
Time frame: Up to approximately 3 years after the last patient is randomized
DCR
Disease control rate (DCR)
Time frame: Up to approximately 3 years after the last patient is randomized
PFS
progression-free period (PFS)
Time frame: Up to approximately 3 years after the last patient is randomized
OS
overall survival (OS)
Time frame: Up to approximately 3 years after the last patient is randomized
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Patients were given a standard dose of almonertinib 110 mg/day, orally, and the first efficacy evaluation was performed 4 weeks later. If there was no disease progression in two consecutive evaluations, the dose of almonertinib was increased to 165 mg /Day, oral ± radiotherapy (decided by the investigator), continue to evaluate the efficacy every 4 weeks until the patient progresses; if there is no disease progression in two consecutive assessments, the dose of almonertinib is increased to 220 mg/day, orally ± Radiotherapy treatment (determined by the investigator), continue to evaluate the efficacy every 4 weeks until the patient progresses.