2023 World Conference on Lung Cancer (Posters)-EP12.01. Aumonertinib in EGFR-Mutant NSCLC Patients with Liver Dysfunction after TKI Treatment and NSCLC with Basic Hepatopathy as First-Line Therapy

EP12.01. Aumonertinib in EGFR-Mutant NSCLC Patients with Liver Dysfunction after TKI Treatment and NSCLC with Basic Hepatopathy as First-Line Therapy - PDF(Slides)

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This document provides an overview of a study investigating the efficacy and safety of aumonertinib therapy in patients with liver dysfunction after treatment with first or second-generation EGFR-TKIs, as well as in patients with basic hepatopathy and EGFR-mutant advanced or metastatic NSCLC. The study aims to assess the primary endpoints of overall response rate (ORR) and liver safety, as well as secondary endpoints including disease control rate (DCR), progression-free survival (PFS), and overall survival (OS).<br /><br />The study design is a single-arm, prospective clinical trial. The key inclusion criteria for patient selection include being 18 years or older, having locally advanced or metastatic EGFR-mutant NSCLC, and having been treated with one kind of first or second-generation EGFR-TKIs while experiencing drug-induced liver dysfunction, or having basic hepatopathy and being eligible for treatment with EGFR-TKIs. Other criteria include having a non-irradiated measurable lesion and an ECOG performance status of 0-3.<br /><br />The primary objective of the study is to assess the efficacy of aumonertinib in patients with liver dysfunction after EGFR-TKI treatment and NSCLC with basic hepatopathy. The primary endpoint is ORR according to RECIST v1.1. The study also aims to assess liver safety, including various liver function parameters.<br /><br />The secondary objective is to further assess the efficacy of aumonertinib in the study population, with secondary endpoints including DCR, PFS, and OS, all according to RECIST v1.1 criteria.<br /><br />The study is currently enrolling patients and more information can be found on the clinicaltrials.gov website with the identifier NCT05662813.

Asset Subtitle

Feng Luo

Meta Tag

Speaker Feng Luo

Topic Metastatic NSCLC: Targeted Therapy - EGFR/HER2

Keywords

aumonertinib therapy

liver dysfunction

EGFR-TKIs

hepatopathy

NSCLC

overall response rate

liver safety

disease control rate

progression-free survival

overall survival