Aumolertinib Plus Intrathecal Chemotherapy for Leptomeningeal Metastasis From EGFR-mutated NSCLC and Investigate Prognostic Value of ctDNA

• Status: Recruiting
• Trial end date: 2024-12-31

Summary

This is a prospective, open-label, single-arm clinical trial. The aim of this study is to evaluate the efficacy and safety of almonertinib and intrathecal chemotherapy in patients with advanced EGFR mutation positive (EGFRm+) non-small cell lung cancer (NSCLC) and leptomeningeal metastasis, and to explore the predictive value of dynamic changes of ctDNA in cerebrospinal fluid for efficacy and prognosis. A total of 40 subjects who met the inclusion criteria were enrolled in the study and received almonertinib (165mg, oral, once a day) combined with intrathecal infusion. Before and after treatment, cerebrospinal fluid was extracted for ctDNA detection by a 49 gene detection panel. Treatment continued until disease progression or other discontinuation criteria were met. In addition, the subjects received regular hematological and imaging examinations to evaluate the condition. Finally, through data analysis, the progression-free survival (PFS), disease control rate (DCR), objective response rate (ORR), duration of response (DoR), and overall survival (OS) of patients with EGFR mutation-positive advanced NSCLC and leptomeningeal metastasis who received almonertinib combined with intrathecal infusion chemotherapy were evaluated. The dynamic changes of ctDNA in cerebrospinal fluid before and after treatment were explored and the correlation between the dynamic changes of ctDNA in cerebrospinal fluid and the therapeutic effect was explored.

• Phase: Phase 2

Details

• Lead Sponsor: Three Gorges Hospital of Chongqing University
• Treatments: Pemetrexed