Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06304441
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-03-05
Brief Title:
Intra-pemetrexed Plus Third-generation Small Molecule TKI Drugs eg Osimertinib Versus Third-generation Small Molecule TKI Drugs Alone for Leptomeningeal Metastasis From Epidermal Growth Factor Receptor Mutation-Positive Non-Small-cell Lung Cancer
Sponsor:
Guangzhou Medical University
Organization:
Guangzhou Medical University
Study Overview
Official Title:
A Clinical Trial of Intra-pemetrexed Plus Third-generation Small Molecule TKI Drugs eg Osimertinib Versus Third-generation Small Molecule TKI Drugs Alone for Leptomeningeal Metastasis From Epidermal Growth Factor Receptor Mutation-Positive Non-Small-cell Lung Cancer
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:
Intrathecal chemotherapy is one of the mainstay treatment options for leptomeningeal metastases Pemetrexed is one of the first-line chemotherapeutic agents for non-squamous non-small cell lung cancer NSCLC Since 2017 intrathecal pemetrexed has shown good efficacy for patients with leptomeningeal metastases from NSCLC It has been recommended as the preferred drug for intrathecal chemotherapy by the Chinese Society of Clinical Oncology CSCO guidelines Tyrosine kinase inhibitors TKIs play a promising role in the treatment of non-small cell lung cancer patients with epidermal growth factor receptor EGFR mutations Due to its small molecule properties it can effectively penetrate the central nervous system barrier and deliver an effective antitumor effect An international multi-center clinical study published in 2019 confirmed that double-dose of osimertinib showed significant improvement in leptomeningeal metastases from NSCLC with EGFR exon 19 deletion or exon 21 L858RT790M mutation It makes TKIs the mainstay of treatment for patients with EGFR-mutant NSCLC with leptomeningeal metastases However whether third-generation small molecule TKI drugs eg osimertinib combined with intrathecal pemetrexed could benefit patients with LM from EGFR- mutant NSCLC remains undetermined
Detailed Description:
The aim of this Study is to compare the effects of intra-pemetrexed Plus third-generation small molecule TKI drugs eg osimertinib versus third-generation small molecule TKI drugs alone in leptomeningeal metastasis from EGFR mutation positive NSCLC
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