2022 World Conference on Lung Cancer (ePosters)-EP08.02-094. Aumolertinib as First-line Treatment in EGFR-Mutant Pulmonary Adenosquamous Carcinoma (ARISE): A Multicenter, Open-Label, Single-Arm Trial

EP08.02-094. Aumolertinib as First-line Treatment in EGFR-Mutant Pulmonary Adenosquamous Carcinoma (ARISE): A Multicenter, Open-Label, Single-Arm Trial

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The ARISE study is a prospective, multicenter, open-label, single-arm trial that aims to evaluate the efficacy and safety of aumolertinib as a first-line treatment for patients with EGFR-mutant adenosquamous carcinoma (ASC) of the lungs. ASC is a relatively rare type of lung cancer, accounting for only a small percentage of cases. Previous studies have shown that ASCs are often associated with EGFR mutations.<br /><br />The study will enroll patients aged 18-80 years with stage IIIB/IV EGFR-mutant ASC. Patients must not have received prior systemic anti-cancer therapy for ASC or mixed adenocarcinoma and squamous cell carcinoma, and they must have confirmed EGFR sensitive mutations. Patients with a history of interstitial lung disease or any evidence of clinically active ILD will be excluded.<br /><br />The primary objective of the study is to assess the efficacy of aumolertinib by measuring progression-free survival (PFS) according to RECIST v1.1. Secondary objectives include assessing objective response rate (ORR), disease control rate (DCR), duration of response (DoR), and intracranial ORR, DCR, and PFS. Additionally, the study will assess overall survival, quality of life, and safety.<br /><br />The study will enroll patients from 64 sites in China, with the first patient expected to be enrolled in March 2021. The estimated completion of the study is in the first quarter of 2025.<br /><br />The ARISE study is sponsored by Jiangsu Hansoh Pharmaceutical Group Co., Ltd. More information about the study can be found at the clinicaltrial.gov website.<br /><br />In summary, the ARISE study is a clinical trial that aims to evaluate the efficacy and safety of aumolertinib as a first-line treatment for patients with EGFR-mutant ASC. The study will assess various endpoints, including PFS, ORR, DCR, DoR, intracranial responses, overall survival, quality of life, and safety.

Asset Subtitle

Gen Lin

Meta Tag

Speaker Gen Lin

Topic Metastatic Non-small Cell Lung Cancer - Molecular Targeted Treatments

Keywords

ARISE study

aumolertinib

EGFR-mutant adenosquamous carcinoma

lung cancer

ASC

progression-free survival

objective response rate

overall survival

quality of life

safety