Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
Study NCT ID:
NCT06971406
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-14
First Post:
2025-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High-Dose Firmonertinib Combined With Bevacizumab and Intrathecal Pemetrexed in the Treatment of EGFR-Mutated Non-Small Cell Lung Cancer With Leptomeningeal Metastasis
Sponsor:
Qiming Wang
Organization:
Study Overview
Official Title:
A Multicenter, Prospective Phase II Clinical Study of 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
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FLAME-1
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: