This is a prospective, single-center, single-arm, phase II study evaluating the efficacy and safety of neoadjuvant aumolertinib in previously untreated patients with AI-diagnosed EGFR-mutant and resectable pulmonary ground-glass opacity. After informed consent signed, enrolled patients will undergo a treatment period and a follow-up period. During the treatment period, patients will receive aumolertinib treatment (110mg, p.o., QD) for 8 weeks. The surgery can be performed after a 1 to 2-week discontinuation period; if the patient does not consent to undergo surgery, follow-up can be conducted instead. If patients experience disease progression during the treatment period, they will be withdrawn from the study. During the follow-up period, the investigator will provide appropriate treatment recommendations based on the patient's condition and pathological results after surgical resection of the target lesion. Postoperative patients (or patients who completed the medication treatment and were followed up) will be monitored every six months for a duration of one year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Aumolertinib treatment (110mg, p.o., QD) for 8 weeks
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGORR (Objective Response Rate)
ORR (Objective Response Rate) is defined as the proportion of participants who confirmed at least one CR (Complete Response) or PR (Partial response) before disease progression based on Response Evaluation Criteria in Solid Tumors (RECIST)1.1 as assessed by the investigator.
Time frame: 3 months.
pCR (Pathological Complete Response)
pCR (Pathological Complete Response) is defined as the proportion of patients in whom no tumor cells are found in all pathological samples after surgical resection following neoadjuvant treatment.
Time frame: 3 months.
MPR (Major Pathological Response)
MPR (Major Pathological Response) is defined as the presence of residual tumor of less than 10% on pathological assessment after neoadjuvant treatment-induced tumor regression.
Time frame: 3 months.
PFS (Progression-Free Survival)
PFS (Progression-Free Survival) is defined as the time from the first dose of study intervention until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy prior to progression.
Time frame: 1 year.
OS (Overall Survival)
OS (Overall Survival) is defined as the time from the initial administration of treatment to the date of death due to any cause. Patients who have not died at the time of statistical analysis will have their survival time censored at the last known date of their survival.
Time frame: 1 year.
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