This is a prospective, multicenter, randomized, controlled clinical study of NSCLC patients with intracranial oligo-metastatic EGFR-sensitive mutations treated with EGFR-TKI Almonertinib , according to the implementation time of brain radiotherapy. Patients were randomly divided into two groups, experimental group (early intervention group of brain radiotherapy) : the brain radiotherapy started within 1 month of TKI treatment, the brain radiotherapy here specifically refers to stereotactic radiotherapy; Control group (brain radiotherapy late intervention group) : Brain radiotherapy was given within 3 months after brain progression during TKI treatment. The differences in OS,iPFS, PFS, iORR, safety, neurocognitive function and quality of life between the two groups were compared.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
232
Patients were randomly divided into two groups, experimental group (early intervention group of brain radiotherapy) : the brain radiotherapy started within 1 month of TKI treatment, the brain radiotherapy here specifically refers to stereotactic radiotherapy; Control group (brain radiotherapy late intervention group) : Brain radiotherapy was given within 3 months after brain progression during TKI treatment.
almonertinib po 110mg QD
Sun-Yat-Sen university
Guangdong, Guangzhou, China
RECRUITINGoverall survival
The time from randomization to death from any cause.
Time frame: 3 years
intracranial progression free survival
patients were randomized from the time of observation of intracranial disease progression or death from any cause
Time frame: 2 years
progression free survival
patients were randomized from the time of observation of systemic disease progression or death from any cause
Time frame: 2 years
intracranial objective response rate
proportion of patients with complete or partial response of intracranial lesions
Time frame: 6 months
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