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Clinical Trial Summary

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 If patients experience disease progression during the treatment period, they will be withdrawn from the study.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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05946460
Study type Interventional
Source The First Affiliated Hospital of Guangzhou Medical University
Contact Wenhua Liang, M.D
Phone +86-13710249454
Email liangwh1987@163.com
Status Recruiting
Phase Phase 2
Start date August 15, 2023
Completion date July 10, 2025

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