Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05813522
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-04-14
First Post:
2023-04-03
Brief Title:
Furmonertinib in Patients With Leptomeningeal Metastases Associated With EGFR Mutated NSCLC
Sponsor:
First Affiliated Hospital of Zhejiang University
Organization:
First Affiliated Hospital of Zhejiang University
Study Overview
Official Title:
Efficacy and Safety Analysis of Furmonertinib in Patients With Leptomeningeal Metastases Associated With EGFR Mutated NSCLCGuiding by Cerebrospinal Fluid ctDNA Detection
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-04
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:
The goal of this clinical trial is to evaluate the clinical efficacy and safety of Furmonertinib in EGFR mutated NSCLC patients with leptomeningeal metastasis and to explore the feasibility of CSF ctDNA detection for efficacy evaluation Participants will be treated with 160mg Furmonertinib daily and tumor evaluation will be performed every 6-8 weeks The participants blood and cerebrospinal fluid samples will be collected three times during the study for ctDNA detection
Detailed Description:
Advanced non-small cell lung cancer patients with leptomeningeal metastases tend to have a worse prognosis Currently no standard therapeutic regimen for LM has been established because of its rarity and heterogeneity Targeted therapy is the primary treatment of patients with EGFRm of NSCLC The drug concentration in cerebrospinal fluid is the key factors affecting the curative effect of intracranial metastatic lesions The widespread application of EGFR-TKIs in clinical practice has significantly prolonged the survival period of patients with EGFR mutations but the standard dose of first- and second-generation EGFR-TKIs show poor control of intracranial metastasisFurmonertinib is a third-generation EGFR-TKI targeting both sensitising EGFR and EGFR T790M mutations Phase 2 clinical study of furmonertinib revealed that furmonertinib was clinically effective with acceptable toxicity in patients with EGFR T790M mutated advanced NSCLC including in patients with CNS metastases At present some study has found that the dynamic changes of EGFR in plasma ctDNA can be used to evaluate the prognosis of NSCLC patients Some study has also observed that the copy number variations in CSF ctDNA of NSCLC patients with LM are related to the curative effect Therefore CSF ctDNA may become a new biomarker to assess the therapeutic effect of LM This is a single-center open single-arm exploratory phase 2 trial evaluating the clinical efficacy and safety of Furmonertinib in EGFR mutated NSCLC patients with leptomeningeal metastasis and to explore the feasibility of CSF ctDNA detection for efficacy evaluation
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