Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06339242
Status:
RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-03-25
Brief Title:
A Study of Furmonertinib Combined With Chemotherapy in the Treatment of NSCLC With Leptomeningeal Metastasis
Sponsor:
Jiangsu Province Nanjing Brain Hospital
Organization:
Jiangsu Province Nanjing Brain Hospital
Study Overview
Official Title:
A Single-arm Prospective Clinical Study of Double Dose of Furmonertinib Combined With Lateral Ventricular Chemotherapy in the Treatment of EGFR-mutant Lung Cancer With Leptomeningeal Metastasis After Third-generation EGFR-TKIs Resistance
Status:
RECRUITING
Status Verified Date:
2024-03
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:
None
Brief Summary:
Leptomeningeal metastasis is a fatal complication of advanced lung cancer There is no standard treatment for leptomeningeal metastasis after third-generation EGFR-TKIs The Furmonertinib prototype persists longer in brain tissue and its metabolites can also penetrate the blood-brain barrier Ommaya cystlateral ventricle chemotherapy can quickly control the progression of intracranial lesions The aim of this study is to evaluate the LM progression-free survival LM-PFS of Furmonertinib combined with lateral ventricular chemotherapy in the treatment of leptomeningeal metastatic NSCLC after third-generation EGFR-TKIs resistance
Detailed Description:
At present there is still a lack of prospective randomized clinical trials on the treatment of LM most of which are small sample studies retrospective analysis and clinical experience with low level of evidence and limited clinical guidance Improving the clinical outcome of patients with LM has become an urgent problem to be solved in clinical treatment Our previous team has reported for the first time that Furmonertinib combined with lateral ventricular chemotherapy can not only effectively improve the neurological symptoms caused by LM but also prolong the survival time of patients with limited and controllable side effects which provides a new treatment approach for EGFR mutation-positive NSCLC accompanied by LM Therefore based on the structural and pharmacological differences between the three generations of EGFR-TKIs combined with Ommaya lateral ventricle chemotherapy can rapidly control the progression of intracranial lesions The aim of this study is to explore whether double dose of Furmonertinib combined with Ommya intracapsular ventricle chemotherapy can provide survival benefits for advanced EGFR mutation-positive NSCLC with leptomeningeal metastasis after third-generation EGFR-Tkis
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