Efficacy and safety of postoperative adjuvant treatment of NSCLC patients with Aumolertinib.
This is a multi-center, two-arm clinical study. In patients with stage I non-squamous non-small cell lung cancer (NSCLC) with EGFR 19del/21L858R with solid, micropapillary, and/or complex gland components ≥10% who have not received any systemic treatment, to evaluate the efficacy and safety of postoperative adjuvant Aumolertinib in NSCLC patients .
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
104
All subjects who meet the enrollment conditions will be included in the Aumolertinib monotherapy group: Orally 110 mg Aumolertinib tablets (55 mg/tablet, 2 tablets/day) once a day until recurrence or completion of treatment or reaching the standard of discontinuation.
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGShanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
RECRUITING2-year Disease free survival (DFS) rate
Defined as the proportion of patients alive and disease free at 2 years,estimated from Kaplan Meier plots of the primary endpoint of DFS at the time of the primary analysis
Time frame: From date of treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
3-, 4-, and 5-year DFS rate
Defined as the proportion of patients alive and disease free at 3, 4 and 5 years, respectively, estimated from Kaplan Meier plots of the primary endpoint of DFS at the time of the primary analysis.
Time frame: From date of treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Overall Survival (OS)
Defined as the time from the date of treatment start until date of death due to any cause
Time frame: Start of study drug to Survival Endpoint through study completion, an average of 5 years, assessed up to 60 months
Patient health-related quality of life and symptoms (HRQoL) by SF-36v2 Health Survey
Defined as a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section and the scores range from 0-100. A score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time frame: From date of treatment start until treatment completion or discontinuation, assessed up to 60 months
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