Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440954
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-04-23
Brief Title:
Efficacy and Resistance Mechanisms of IP in NSCLC With Leptomeningeal Metastases
Sponsor:
Hunan Province Tumor Hospital
Organization:
Hunan Province Tumor Hospital
Study Overview
Official Title:
To Investigate the Efficacy and Resistance Mechanisms of Intrathecal Pemetrexed in Advanced Non-small Cell Lung Cancer NSCLC Patients Harboring Oncogenic Mutations With Leptomeningeal Metastases
Status:
RECRUITING
Status Verified Date:
2024-05
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:
EPIC
Brief Summary:
This is a prospective interventional study clinical study to investigate the efficacy and resistance mechanisms of intrathecal pemetrexed in patients with driver gene mutations advanced NSCLC with leptomeningeal metastases
Detailed Description:
This is a prospective interventional clinical study aimed at investigating the efficacy and resistance mechanisms of intrathecal pemetrexed in advanced NSCLC patients with EGFR ALK and ROS1 mutations presenting leptomeningeal metastases Approximately 30 advanced NSCLC patients with EGFR ALK and ROS1 mutations who have developed leptomeningeal metastases following TKI resistance will receive intrathecal pemetrexed Cerebrospinal fluid samples will be collected before and after pemetrexed resistance to analyze molecular mechanisms and differences Second-generation gene detection will be performed to identify potential resistance mechanisms to pemetrexed The study is expected to commence recruitment in mainland China around April 2024 with an anticipated completion date in April 2025
Study Oversight
Has Oversight DMC:
None
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?:
None