Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06362980
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-03-28
Brief Title:
A Study With BPI-1178 and Osimertinib in Advanced Non-small Cell Lung Cancer Patients With EGFR Mutations
Sponsor:
National Cancer Center China
Organization:
National Cancer Center China
Study Overview
Official Title:
An Open-label Single-arm Investigator-initiated Phase I Clinical Study Evaluating BPI-1178 Capsules in Combination With Osimertinib Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer With EGFR Mutations
Status:
RECRUITING
Status Verified Date:
2024-07
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:
EGFR
Brief Summary:
BPI-1178 is a novel orally administered inhibitor of both cyclin-dependent kinase 4 CDK4 and CDK6 kinase activity This open-label investigator-initiated trial IIT phase I study was designed to evaluate the safety and efficacy of oral BPI-1178 in combination with osimertinib in patients with locally advanced or metastatic non-small cell lung cancer NSCLC and epidermal growth factor receptor EGFR Mutations
Detailed Description:
This study is an open-label single-arm single-center clinical study initiated by the researcher The plan is to enroll 20 patients with locally advanced or metastatic NSCLC harboring EGFR mutations The study aims to assess the safety and conduct preliminary observations on the efficacy of BPI-1178 capsules in combination with osimertinib in treating locally advanced or metastatic EGFR mutation-positive NSCLC patients who have developed resistance to osimertinib
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?:
False
Is an FDA AA801 Violation?:
None