2023 World Conference on Lung Cancer (Posters)-P2.09. Aumolertinib Combined Intrathecal Chemotherapy for LM from EGFR-Mutated NSCLC and Prognostic Value of Dynamic Changes in cfDNA Profiles

P2.09. Aumolertinib Combined Intrathecal Chemotherapy for LM from EGFR-Mutated NSCLC and Prognostic Value of Dynamic Changes in cfDNA Profiles - PDF(Abstract)

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Leptomeningeal metastasis (LM) is a severe complication of advanced non-small cell lung cancer (NSCLC) that occurs in about 3% to 5% of patients at initial diagnosis or during treatment. The incidence of LM increases to 9.4% in patients with EGFR mutations. Current treatment options are limited, and the median survival remains low, ranging from 1-3 to 3-11 months. This study aims to assess the efficacy and safety of high-dose aumolertinib, a third-generation EGFR tyrosine kinase inhibitor, combined with intrathecal chemotherapy via an Ommaya reservoir in patients with LM from EGFR-mutated NSCLC. <br /><br />The study plans to enroll approximately 40 patients with LM from NSCLC who have EGFR mutations. The patients will receive aumolertinib orally once daily at a dosage of 165mg, along with intrathecal chemotherapy using pemetrexed via an Ommaya reservoir once every 3 weeks. CSF and plasma samples will be collected before treatment and at the time of disease progression. The primary endpoint of the study is progression-free survival (PFS) according to RECIST 1.1 criteria. Secondary endpoints include intracranial progression-free survival (iPFS), objective response rate (ORR), disease control rate (DCR), duration of remission (DoR), overall survival (OS), and therapeutic toxicities.<br /><br />The rationale for this study is the significant treatment efficacy and favorable safety profile of aumolertinib in EGFR-mutated NSCLC patients with brain metastases. Intrathecal chemotherapy through an Ommaya reservoir provides a more convenient and safer route for treating leptomeningeal disease and obtaining cerebrospinal fluid (CSF) samples compared to repeated lumbar punctures. In addition, the study will explore the prognostic value of dynamic changes in cell-free DNA (cfDNA) profiles.<br /><br />In conclusion, this ongoing clinical trial aims to evaluate the effectiveness and safety of high-dose aumolertinib combined with intrathecal chemotherapy in patients with LM from EGFR-mutated NSCLC. The study also seeks to assess the prognostic value of dynamic changes in cfDNA profiles. The results of this trial may provide valuable insights into the optimal treatment strategy for LM in this specific patient population.

Asset Subtitle

Wei Wang

Meta Tag

Speaker Wei Wang

Topic Metastatic NSCLC: Targeted Therapy - EGFR/HER2

Keywords

Leptomeningeal metastasis

NSCLC

EGFR mutations

aumolertinib

intrathecal chemotherapy

Ommaya reservoir

progression-free survival

cerebrospinal fluid

cfDNA profiles

clinical trial