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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
110mg Almonertinib is administered orally daily since the first day after stereotactic radiosurgery treatment (total dose 30 Gy, 5 fractions, day1, 3, 5, calibrated by CBCT before each treatment). For patients who are assessed as oligometastasis three months after Almonertinib treatment, SBRT is recommended for oligometastatic lesions (The number of lesions received SBRT and radiation dose are not standardized).
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, China
Central nerve system duration of response(CNS DOR)
Central nerve system duration of response assessed by RANO-BM criteria
Time frame: 1 year
Intracranial prgression-free survival(PFS)
Intracranial progression free survival assessed by Response Assessment in Neuro-Oncology Brain Metastases(RANO-BM) criteria
Time frame: 1 year
Intracranial response rate(RR)
Intracranial response rate assessed by RANO-BM criteria
Time frame: 1 year
Extracranial RR
Extracranial response rate assessed by Response Evaluation Criteria in Solid Tumors(RECIST) criteria
Time frame: 1 year
overall survival (OS)
overall survival
Time frame: 1 year
Neurocognitive function assessed by mini-mental state examination(MMSE) questionnaire score
Neurocognitive function assessed by mini-mental state examination(MMSE) questionnaire score
Time frame: 1 year
quality of life(QoL) assessed by EORTC QLQ-C30
Quality of Life assessed by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire core 30(EORTC QLQ-C30)
Time frame: 1 year
quality of life(QoL) assessed by EORTC QLQ-BN20
Quality of Life assessed by The European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnaire Brain Cancer 20(BN20)
Time frame: 1 year
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