Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
NCT ID:
NCT06971406
Brief 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.
Study:
NCT06971406
Study Brief:
Protocol Section:
NCT06971406