Ignite Creation Date:
2024-05-06 @ 4:03 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04858958
Status:
RECRUITING
Last Update Posted:
2023-01-18
First Post:
2021-04-12
Brief Title:
Study of FURMONERTINIB in Patients With NSCLC Having Exon 20 Insertion Mutation
Sponsor:
Allist Pharmaceuticals Inc
Organization:
Allist Pharmaceuticals Inc
Study Overview
Official Title:
A Phase Ib Randomized Open-label Multi-center Study to Evaluate the Preliminary Efficacy and Safety of Furmonertinib Mesilate in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutation
Status:
RECRUITING
Status Verified Date:
2023-01
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:
FAVOUR
Brief Summary:
This is a phase Ⅰb multi-center clinical study To explore the preliminary efficacy and safety of Furmonertinib Mesilate at different doses in locally advanced or metastatic NSCLC patients with EGFR exon 20 insertion mutation
The study plans to enroll 30 subjects including 20 treated patients and 10 treatment-naïve patients The subjects with disease progression after previous systematic anti-tumor therapy will be randomized to receive Furmonertinib Mesilate 160 mgday N10 or 240 mgday N10 respectively The treatment-naïve patients do not need to be randomized and all will receive Furmonertinib Mesilate 240 mgday N10 until disease progression death or intolerability
The primary endpoint is ORR the secondary study endpoints include DCR DOR DepOR PFS OS CNS ORR safety and the PK profile of Furmonertinib Mesilate and its metabolites AST5902
In addition the peripheral blood ctDNA will be collected and analyzed in this study
The study plans to enroll 30 subjects including 20 treated patients and 10 treatment-naïve patients The subjects with disease progression after previous systematic anti-tumor therapy will be randomized to receive Furmonertinib Mesilate 160 mgday N10 or 240 mgday N10 respectively The treatment-naïve patients do not need to be randomized and all will receive Furmonertinib Mesilate 240 mgday N10 until disease progression death or intolerability
The primary endpoint is ORR the secondary study endpoints include DCR DOR DepOR PFS OS CNS ORR safety and the PK profile of Furmonertinib Mesilate and its metabolites AST5902
In addition the peripheral blood ctDNA will be collected and analyzed in this study
Detailed Description:
None
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