Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04545710
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-08
First Post:
2020-09-04
Brief Title:
Osimertinib and Abemaciclib in EGFR Mutant Non-Small Cell Lung Cancer After Osimertinib Resistance
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
A Phase II Trial of Osimertinib and Abemaciclib With a Focus on Non-Small Cell Lung Cancer Patients With EGFR Activating Mutations With Osimertinib Resistance
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
Lung cancer is the leading cause of cancer deaths Advances in the systemic treatment of non-small cell lung cancer NSCLC have increased survival in metastatic EGFR-mutated NSCLC However resistance to therapy can develop
Detailed Description:
Lung cancer is the leading cause of cancer deaths Advances in the systemic treatment of non-small cell lung cancer NSCLC have increased survival in metastatic EGFR-mutated NSCLC However resistance to therapy can develop
NSCLC tumors with EGFR-activating mutations are exquisitely sensitive to EGFR tyrosine kinase inhibitors with overall response rates approximating 80 The third generation EGFR compound osimertinib is a standard first line option Resistance to the third generation EGFR-TKI osimertinib can develop with a median PFS of 189 months Current research examining acquired resistance to EGFR-TKIs has focused on overcoming these main mechanisms of EGFR-TKI resistance and understanding the impact of co-occurring alterations Frequently altered pathways concomitantly affected with EGFR in lung cancer are cell cycle genes This study will explore a strategy to inhibit EGFR and CDK46 in resistant EGFR mutated lung cancer patients post progression on osimertinib
NSCLC tumors with EGFR-activating mutations are exquisitely sensitive to EGFR tyrosine kinase inhibitors with overall response rates approximating 80 The third generation EGFR compound osimertinib is a standard first line option Resistance to the third generation EGFR-TKI osimertinib can develop with a median PFS of 189 months Current research examining acquired resistance to EGFR-TKIs has focused on overcoming these main mechanisms of EGFR-TKI resistance and understanding the impact of co-occurring alterations Frequently altered pathways concomitantly affected with EGFR in lung cancer are cell cycle genes This study will explore a strategy to inhibit EGFR and CDK46 in resistant EGFR mutated lung cancer patients post progression on osimertinib
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None