This study is a prospective, multicenter, single arm clinical study. Thirty subjects who will have been diagnosed with locally advanced or metastatic non-small cell lung cancer with EGFR 21L858R mutation detected in lung cancer tissue or peripheral blood will be recruited and treated with anlotinib and aumolertinib. The efficacy will be evaluated according to the Solid Tumor Efficacy Evaluation Standard (RECIST 1.1), and evaluated every 6 to 8 weeks. The survival status and adverse reactions of the subjects will be recorded. The study will be terminated when the subjects experience disease progression or intolerable drug toxicity, or the subjects withdraw their informed consent. The main purpose of the study is to observe the efficacy and safety of the combined treatment regimen in such subjects. The primary endpoint of the study is median progression free survival (mPFS); The secondary study endpoints are objective response rate (ORR), disease control rate (DCR), median overall survival time (mOS), and safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Participants were treated with anlotinib and aumolertinib.Aumolertinib mesylate tablets are administered 110 mg orally once a day,and anlotinib hydrochloride capsules were given 12 mg once a day, taken for 2 weeks and then discontinued for 1 week, with a treatment cycle every 21 days. If grade 3 or above treatment-related toxicity occurs, anlotinib can be reduced to 10 mg or 8 mg once daily.
First Affiliated Hospital of Kunming University
Kunming, Yunnan, China
RECRUITINGmedian Progressive Free Survival (mPFS)
The time from the subject's initiation of treatment with anlotinib and aumolertinib to the occurrence of disease progression.
Time frame: up to two years
objective response rate(ORR)
The percentage of subjects who achieved complete remission or partial remission after 6 to 8 weeks of treatment with anlotinib and aumolertinib.
Time frame: 6 to 8 weeks after the subjects used the investigational drugs
Disease control rate (DCR)
The percentage of subjects whose tumors shrink or remain stable after 6 to 8 weeks of treatment with anlotinib and aumolertinib.
Time frame: 6 to 8 weeks after the subjects used the investigational drugs
median Overall survival(mOS)
Median time from subjects' enrollment to death for any reasons. For subjects who are lost to follow-up before death, the last follow-up time will be calculated as the time of death.
Time frame: up to three years
Safety of combined therapy
Number of participants who had drug-related adverse reactions during the trial and the degree of adverse reactions.
Time frame: up to two years
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