Ignite Creation Date:
2024-05-06 @ 5:52 PM
Last Modification Date:
2024-10-26 @ 2:37 PM
Study NCT ID:
NCT05466149
Status:
RECRUITING
Last Update Posted:
2023-02-01
First Post:
2022-07-14
Brief Title:
Efficacy and Safety of Furmonertinib in Patients With Locally Advanced or Metastatic NSCLC With EGFR Exon 20 Insertion
Sponsor:
Allist Pharmaceuticals Inc
Organization:
Allist Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 2 Multicenter Open-Label Study to Assess the Efficacy and Safety of Furmonertinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer NSCLC With Epidermal Growth Factor Receptor EGFR Exon 20 Insertion Mutations
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:
None
Brief Summary:
This is a Phase 2 Multicenter Open-Label Study to Assess the Efficacy and Safety of Furmonertinib in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer NSCLC with Epidermal Growth Factor Receptor EGFR Exon 20 Insertion Mutations
The study plans to enroll approximately 100 patients from approximately 70 sites Patients are locally advanced or metastatic NSCLC with EGFR exon 20 insertions who have progressed during or after platinum-based chemotherapy Furmonertinib Mesilate will be treated 240 mg QD until disease progression or unacceptable toxicity
Primary endpoint is ORR Secondary endpoints include DOR DCR DepOR PFS OS CNS ORR CNS DOR CNS PFS safety and the PK profile of Furmonertinib Mesilate and its metabolites AST5902
The study plans to enroll approximately 100 patients from approximately 70 sites Patients are locally advanced or metastatic NSCLC with EGFR exon 20 insertions who have progressed during or after platinum-based chemotherapy Furmonertinib Mesilate will be treated 240 mg QD until disease progression or unacceptable toxicity
Primary endpoint is ORR Secondary endpoints include DOR DCR DepOR PFS OS CNS ORR CNS DOR CNS PFS safety and the PK profile of Furmonertinib Mesilate and its metabolites AST5902
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