This is a prospective, multi-center, single-arm clinical trial to evaluate the safety and effectiveness of Almonertinib treatment in patients with EGFR mutation positive and advanced non-small cell lung cancer (NSCLC) who are intolerant to the safety of osimertinib treatment.
This is a prospective, multi-center, single-arm clinical trial to evaluate the safety and effectiveness of Almonertinib treatment in patients with EGFR mutation positive and advanced non-small cell lung cancer (NSCLC) who are intolerant to the safety of osimertinib treatment. Patients meeting the criteria for inclusion and exclusion were included in the Almonertinib treatment group and received 110 mg of Almonertinib orally once a day.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Almonertinib is a class 1 new drug,the third-generation small molecule EGFR TKI, which can irreversibly and highly selectively inhibit EGFR sensitive mutations (such as exon 19 deletion and L858R mutation) and T790M resistance mutations. Patients meeting the criteria for inclusion and exclusion were included in the Almonertinib treatment group and received 110 mg of Almonertinib orally once a day.
Assess the safety of Almonertinib: Number of AEs/SAEs
Number of adverse events (AEs)/serious adverse events (SAEs)
Time frame: Continuously throughout the study until 28 days after Termination of the treatment
Assess the anti-tumor activity: Progression Free Survival (PFS)
To assess the efficacy of Almonertinib in the treatment of advanced NSCLC patients with EGFR-sensitive mutations who are intolerant to safety after osimertinib treatment by assessment of progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Time frame: From date of baseline until the date of disease progression or discontinuation from study, assessed up to 24 months
Assess the anti-tumor activity: Objective response rate (ORR)
ORR is defined as the percentage of patients who have at least 1 response of CR or PR prior to any evidence of progression assessed up to 24 months.
Time frame: From date of baseline until the date of disease progression or discontinuation from study, assessed up to 24 months
Assess the anti-tumor activity: Disease control rate (DCR)
The DCR is defined as the proportion of patients with a best overall response of CR, PR, or SD assessed up to 24 months.
Time frame: From date of baseline until the date of disease progression or discontinuation from study, assessed up to 24 months
Assess the anti-tumor activity: Duration of response (DoR)
DoR is defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression assessed up to 24 months.
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Time frame: the time from date of documented progression or death in the absence of disease progression assessed up to 24 months.
Assess the anti-tumor activity: Overall survival (OS)
Start of study drug to Survival Endpoint through study completion, an average of 4 years.
Time frame: an average of 4 years
Assess the anti-tumor activity: Depth of Remission (DepOR)
The depth of remission (change in tumor size) refers to the amount of change in the sum of the length of the longest diameter of the target lesion defined by RECIST 1.1 when no new lesions appear or no non-target lesions have progressed compared with the baseline.
Time frame: through study completion, an average of 1 year