598TiP - Exploration of aumolertinib in first-line treatment for advanced non-small cell lung cancer patients of performance status 3 with EGFR mutations (19del and L858R)

Background

Lung cancer is currently the leading cause of death in cancer patients, non-small cell lung cancer (NSCLC) accounts for 80%-85% and the morbidity is increasing. About 70% of the cases have reached the advanced stage at the time of diagnosis. In some patients, the ECOG performance status (PS) score rates from 2 to 4 with worse prognosis and tolerance. Hence, Prof. Zhou's team defined the concept of "advanced severe lung cancer" in 2017. Currently, most guidelines recommend EGFR-TKIs as first-line treatment for EGFR mutation-positive (19del and L858R) patients. However, PS 2-4 patients were not included in most clinical trials. Thus, the efficacy and safety of EGFR-TKIs for PS 2-4 patients are still unknown in the real world. Aumolertinib is a third-generation EGFR-TKI independently developed in China with lower incidence of adverse events, which may be a better choice for advanced severe lung cancer patients. Thus, this study was designed to explore the efficacy and safety of aumolertinib in the first-line treatment of advanced non-small cell lung cancer patients of PS 3 with EGFR mutations. This may provide valuable hints for clinical applications.

Trial design

A total of 61 patients with EGFR mutations positive (19del and L858R) advanced non-small cell lung cancer with PS 3 will be enrolled and applying Aumolertinib 110 mg PO QD until progression. The primary endpoints are Objective Response Rate (ORR) and the duration of PS improved from 3 at baseline to 1. Secondary endpoints are progression-free survival (PFS), overall survival (OS), quality of life (QoL), disease control rate (DCR) and safety.

Clinical trial identification

NCT05826483.

Legal entity responsible for the study

The First Affiliated Hospital of Guangzhou Medical University.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.