This is a prospective, open-label, multi-center, single-arm clinical trial
The purpose of this study is to assess the efficacy and safety of sac-TMT combined with third-generation EGFR-TKI with/without intracranial radiotherapy in subjects with EGFR-mutated NSCLC and brain metastasis who have failed prior EGFR-TKI treatment. Eligible subjects will receive sac-TMT (4 mg/kg, twice weekly (Q2W)) + third-generation EGFR-TKI ± intracranial radiotherapy. The decision to initiate intracranial radiotherapy will be determined by the investigator based on the patient's clinical condition.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Eligible subjects will receive sac-TMT (4 mg/kg, twice weekly (Q2W)) + third-generation EGFR-TKI ± intracranial radiotherapy. The decision to initiate intracranial radiotherapy will be determined by the investigator based on the patient's clinical condition.
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
6-month PFS rate
6-month PFS rate as assessed by the investigators according to RECIST v1.1.
Time frame: 6 months post treatment initiation date (maximum follow-up of 36 months)
Overall ORR and DCR
Overall ORR and DCR as assessed by the investigators according to RECIST v1.1
Time frame: From initiation of treatment to disease progression or death from any cause, whichever occurs first (maximum follow-up of 36 months)
DOR
DOR as assessed by the investigators according to RECIST v1.1
Time frame: From first disease response until tumor progression (maximum follow-up of 36 months).
OS
Time from treatment initiation to date of death due to any cause or last day of contact.
Time frame: From treatment initiation to death due to any cause or last day of contact, whichever occurred first (maximum follow-up of 36 months)
Safety endpoints
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) \[based on the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI)\]
Time frame: From first dose of study treatment until 30 days after the last dose, assessed up to 36 months.
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