The study will evaluate the efficacy and safety of treatment with sunvozertinib in combination with Anlotinib in patients whose disease has progressed following first-line EGFR-TKIs treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Sunvozertinib 300 mg once daily (QD) with Anlotinib 12mg once daily (QD in Day 1-14) ,21 days in one cycle.
ORR
Objective response rate (ORR) as assessed by the investigator according to RECIST 1.1 criteria.
Time frame: initiate from first dose until the date of confirmed response, assessed up to 24 weeks
PFS
PFS as assessed by the investigator according to RECIST 1.1
Time frame: initiate from first dose, every 6 weeks until PD or study close, an average of 1 year
OS
initiate from first dose to death from any cause
Time frame: through study completion, an average of 1.5 years
DoR
The period from the first judgment of CR or PR to PD
Time frame: an average of 1 year
AE
TRAE as assessed by the investigator according to CTCAE 5.0
Time frame: through study completion, an average of 1 year
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