High-Dose Firmonertinib Combined With Bevacizumab and Intrathecal Pemetrexed in the Treatment of EGFR-Mutated Non-Small Cell Lung Cancer With Leptomeningeal Metastasis

• Status: NOT_YET_RECRUITING
• Trial end date: 2027-06-01

Summary

Primary Objective:

To evaluate the efficacy of high-dose firmonertinib combined with bevacizumab and intrathecal pemetrexed in EGFR Ex19del/L858R-mutated non-small cell lung cancer (NSCLC) with leptomeningeal metastasis (LM), as measured by Overall Survival (OS).

Secondary Objectives:

1. To assess the efficacy of this regimen in EGFR Ex20ins/PACC/L861Q-mutated NSCLC with LM.

2. To further evaluate therapeutic outcomes across cohorts, including:

• Time to Treatment Failure (TTF)
• Leptomeningeal Objective Response Rate (ORR-LM)
• Clinical Response Rate

3. To analyze the impact of this regimen on \*quality of life\* using standardized metrics:

• EORTC QLQ-C30
• EORTC QLQ-LC13

4. To assess safety profiles across cohorts, focusing on:

• Incidence and severity of adverse events (AEs) graded per \*CTCAE v5.0\*
• Frequency of treatment-related toxicities

Exploratory Objectives:

To investigate correlations between dynamic changes in:

• Plasma-derived circulating tumor DNA (ctDNA)
• Cerebrospinal fluid-derived cell-free DNA (cfDNA) and clinical outcomes through comparative analysis of genomic profiling and epigenetic signatures before and after treatment.

• Phase: PHASE2

Details

• Lead Sponsor: Qiming Wang