Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06537297
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Intrathecal Pemetrexed Combined With High-dose Furmonertinib and Beva for EGFR-m NSCLC With Leptomeningeal Metastases
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Efficacy and Safety of Intrathecal Pemetrexed With High-dose Furmonertinib Plus Bevacizumab for EGFR-mutant NSCLC Patients With Leptomeningeal Metastases Resistant to Third-generation EGFR-TKIs A Phase II Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aimed to evaluate the efficacy and safety of intrathecal pemetrexed with high-dose Furmonertinib plus bevacizumab for EGFR-mutant non-small cell lung cancer patients with leptomeningeal metastases after resistance to third-generation EGFR-TKIs
Detailed Description:
This prospective interventional study aimed to evaluate the efficacy and safety of intrathecal pemetrexed with high-dose Furmonertinib plus bevacizumab for EGFR-mutant NSCLC patients with leptomeningeal metastases after resistance to third-generation EGFR-TKIs
Approximately 30 EGFR-mutant Non-small cell lung cancer patients with leptomeningeal metastasis or leptomeningeal progression after resistant to third generation EGFR-TKIs were enrolled and treated with intrathecal pemetrexed with high-dose furmonertinib plus bevacizumab cerebrospinal fluid and blood samples will be collected before and after pemetrexed resistance to analyze molecular mechanisms Second-generation gene detection will be performed to identify potential resistance mechanisms to pemetrexed The study is expected to commence recruitment in mainland China in about August 2024 It is expected that the trial will end in April 2026
Approximately 30 EGFR-mutant Non-small cell lung cancer patients with leptomeningeal metastasis or leptomeningeal progression after resistant to third generation EGFR-TKIs were enrolled and treated with intrathecal pemetrexed with high-dose furmonertinib plus bevacizumab cerebrospinal fluid and blood samples will be collected before and after pemetrexed resistance to analyze molecular mechanisms Second-generation gene detection will be performed to identify potential resistance mechanisms to pemetrexed The study is expected to commence recruitment in mainland China in about August 2024 It is expected that the trial will end in April 2026
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None