2022 World Conference on Lung Cancer (ePosters)-EP08.02-001. Concurrent Aumolertinib and Cerebral Radiotherapy as First-Line Treatment for EGFR Mutated Non-small Cell Lung Cancer with Brain Metastases

EP08.02-001. Concurrent Aumolertinib and Cerebral Radiotherapy as First-Line Treatment for EGFR Mutated Non-small Cell Lung Cancer with Brain Metastases

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The study examines the safety and efficacy of combining aumolertinib, a third-generation EGFR-TKI, with cerebral radiotherapy as a first-line treatment for EGFR positive non-small cell lung cancer (NSCLC) patients with brain metastasis. Approximately 16.3%-19% of newly diagnosed NSCLC patients have brain metastasis, and 30%-50% of NSCLC patients develop it during the course of the disease. Patients with EGFR positive-type have a higher risk of brain metastasis. Previous studies have shown that craniocerebral radiotherapy prior to delayed craniocerebral radiotherapy improves overall survival (OS).<br /><br />Aumolertinib is a novel EGFR-TKI that can penetrate the blood-brain barrier, and it has shown efficacy in patients with EGFR-mutant advanced NSCLC. The study aims to determine whether combining EGFR-TKIs and cerebral radiotherapy is more effective than EGFR-TKIs alone. The primary endpoint is intracranial progression-free survival (iPFS), and key secondary endpoints include progression-free survival (PFS), overall survival (OS), objective response rate (ORR), disease control rate (DCR), duration of response (DOR), health-related quality of life (HRQoL), and safety.<br /><br />The study includes patients aged 18-75 years with stage IV NSCLC and brain metastasis, confirmed EGFR sensitive mutations, and no prior systemic anti-cancer/EGFR-TKI therapy. Patients should have measurable disease and an ECOG performance status of 0-1. Prior anti-EGFR-TKI therapy, neuromeningeal disease without intracranial metastases, previous radiotherapy for CNS metastases, and the use of drugs or herbal supplements known to interact with CYP3A4/5 are exclusion criteria.<br /><br />The study will assess the efficacy of aumolertinib combined with cerebral radiation in terms of iPFS, ORR, DCR, DOR, and OS. It will also evaluate patients' quality of life using the EORTC QLQ-C30 and QLQ-LC13 questionnaires, as well as the safety of the combination treatment through the assessment of adverse events, clinical chemistry, haematology, vital signs, and physical examination.<br /><br />This study is sponsored by Jiangsu Hansoh Pharmaceutical Group Co., Ltd.

Asset Subtitle

Ying Wang

Meta Tag

Speaker Ying Wang

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

Keywords

safety

efficacy

aumolertinib

EGFR-TKI

cerebral radiotherapy

first-line treatment

EGFR positive

non-small cell lung cancer

NSCLC

brain metastasis