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 intends to assess the efficacy and safety of stereotactic radiosurgery with sequential almonertinib in treatment-naive EGFR-mutant NSCLC patients with brain metastases.
Name: Almonertinib
Description: Central nerve system duration of response assessed by RANO-BM criteria
Measure: Central nerve system duration of response(CNS DOR) Time: 1 yearDescription: Intracranial progression free survival assessed by Response Assessment in Neuro-Oncology Brain Metastases(RANO-BM) criteria
Measure: Intracranial prgression-free survival(PFS) Time: 1 yearDescription: Intracranial response rate assessed by RANO-BM criteria
Measure: Intracranial response rate(RR) Time: 1 yearDescription: Extracranial response rate assessed by Response Evaluation Criteria in Solid Tumors(RECIST) criteria
Measure: Extracranial RR Time: 1 yearDescription: overall survival
Measure: overall survival (OS) Time: 1 yearDescription: Neurocognitive function assessed by mini-mental state examination(MMSE) questionnaire score
Measure: Neurocognitive function assessed by mini-mental state examination(MMSE) questionnaire score Time: 1 yearDescription: Quality of Life assessed by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire core 30(EORTC QLQ-C30)
Measure: quality of life(QoL) assessed by EORTC QLQ-C30 Time: 1 yearDescription: Quality of Life assessed by The European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnaire Brain Cancer 20(BN20)
Measure: quality of life(QoL) assessed by EORTC QLQ-BN20 Time: 1 yearDescription: Intracranial response rate accessed by volumetric criteria
Measure: Intracranial RR accessed by volumetric criteria Time: 1 yearDescription: intracranial progression rate assessed by brain MRI at 1year
Measure: intracranial progression rate assessed by brain MRI at 1year Time: 1 yearAllocation: N/A
Single Group Assignment
There is one SNP
3. The number of brain metastases ≤ 10, the volume of individual metastases ≤ 15 cc, the diameter of individual metastases ≤ 30 mm, the diameter of metastases in the brainstem ≤ 5 mm, distance of the foci from the optic nerve, or optic cross > 5 mm. 4. EGFR-sensitive mutations (include 19del or L858R mutation or coexist with other types of EGFR mutation). --- L858R ---