Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-28 @ 10:17 AM
Study NCT ID:
NCT06319950
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-dose Furmonertinib Versus Osimertinib in Advanced EGFRm NSCLC Patients With Brain Metastases
Sponsor:
Taizhou Hospital
Organization:
Study Overview
Official Title:
High-dose Furmonertinib Versus Osimertinib as First-line Treatment in Advanced EGFR Mutation-positive NSCLC Patients With Brain Metastases: a Multi-center, Randomized, Controlled, Prospective, Phase II Clinical Trial
Status:
NOT_YET_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:
The investigators were to explore whether high-dose Furmonertinib, compared with osimertinib, could achieve longer survival in patients with EGFR-mutated NSCLC with CNS metastasis.
Detailed Description:
Lung cancer is the leading cause of cancer incidence and death worldwide. Non-small cell lung cancer accounts for about 80-85%, and EGFR mutations occur in about 45-55% of the Asian population. In newly diagnosed NSCLC patients, the rate of brain metastases in advanced NSCLC can be as high as 25% to 44%. The brain metastasis rate of advanced lung adenocarcinoma with EGFR mutation can reach 60%. For NSCLC patients with CNS metastases and EGFR mutations, the PFS of EGFR-TKIs was improved compared with chemotherapy, but neither was satisfactory, even with Osimertinib (third-generation EGFR-TKI). The PFS of patients with CNS metastases treated with Osimertinib was only 15.23 months. Therefore, the diagnosis and treatment of lung cancer patients with brain metastases is still a difficult problem to improve the long-term survival rate of lung cancer. Clinical data and early preclinical studies have shown that Furmonertinib(AST2818) can effectively inhibit the classical mutation of EGFR, especially for intracranial lesions, and is well tolerated. In the FURLONG study, the PFS of patients with CNS metastases was 20.8 months and the ORR were 91%, respectively. This may be due to the unique molecular structure of Furmonertinib, which has the advantage of "double entry into the brain". Furthermore, the investigators' previous research showed that patients treated with 160mg of Furmonertinib after third-generation EGFR-TKIs treatment resistance were divided into intracranial progression mode group and extracranial progression mode group, and finally proven that Furmonertinib 160mg with or without antiangiogenic agents could be an option for patients with advanced NSCLC who have developed resistance after third-generation EGFR-TKIs, especially those who have developed resistance due to intracranial lesion progression. Based on above, the investigators propose to develop a multi-center, randomized, controlled, prospective, Phase II clinical trial in order to explore whether high-dose Furmonertinib could achieve longer survival in patients with EGFR-mutated NSCLC with CNS metastasis, particularly long-term control of intracranial lesions.
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?: