Abstract 598TiP
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.
Resources from the same session
471TiP - A group sequential, response-adaptive randomized double-blinded clinical trial to evaluate add-on olanzapine plus pregabalin to prevent chemotherapy-induced nausea and vomiting (CINV ) in patients belonging to low socio-economic status
Presenter: Mathan Ramasubbu
Session: Poster Display
Resources:
Abstract
472P - Risk of recurrence and optimal adjuvant treatment in invasive lung adenocarcinomas manifesting as radiological part-solid nodules
Presenter: Yang Wo
Session: Poster Display
Resources:
Abstract
473P - Treatment (tx) patterns in resectable stage IA–IIIA non-small cell lung cancer (NSCLC) in China: Subgroup analysis of a global real-world (rw) study
Presenter: Chih-Chi Yang
Session: Poster Display
Resources:
Abstract
474P - The efficacy of image guided coil localisation for surgical resection of undiagnosed solitary lung nodule
Presenter: Jun Rey Leong
Session: Poster Display
Resources:
Abstract
475P - 5-year overall survival and disease free survival outcome between lobectomy and segmentectomy for early stage lung cancer in a mixed Asian population
Presenter: Jianye Chen
Session: Poster Display
Resources:
Abstract
478P - Peri-operative risks in curative lung resection of early stage primary lung cancer patients above 70 years old in a mixed Asian population
Presenter: Ian Goh
Session: Poster Display
Resources:
Abstract
480P - Aumolertinib as adjuvant therapy for resectable stage I-III EGFR-mutant NSCLC: Also effective in EGFR co-mutation
Presenter: Lin Wu
Session: Poster Display
Resources:
Abstract
481P - Comparative analysis of three NGS platforms assessing tumor mutational burden and mutational landscape in resectable non-small cell lung cancer
Presenter: Jii Bum Lee
Session: Poster Display
Resources:
Abstract
482P - Prevalence of EGFR mutations (EGFRm) and its subtypes in patients (pts) with resected stage I-III NSCLC: Results from EARLY-EGFR Singapore cohort
Presenter: Puey Ling Chia
Session: Poster Display
Resources:
Abstract
483P - Genetic profiles and evolutionary trajectory of early stage lung adenocarcinoma (AAH, AIS, MIA and IAC) revealed by multiplex sequecing
Presenter: lixuan lin
Session: Poster Display
Resources:
Abstract