Osimertinib and Abemaciclib in EGFR Mutant Non-Small Cell Lung Cancer After Osimertinib Resistance
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|ClinicalTrials.gov Identifier: NCT04545710|
Recruitment Status : Recruiting
First Posted : September 11, 2020
Last Update Posted : January 25, 2021
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 18.9 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 CDK4/6 in resistant EGFR mutated lung cancer patients post progression on osimertinib.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: Abemaciclib Drug: Osimertinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||November 21, 2020|
|Estimated Primary Completion Date :||September 1, 2022|
|Estimated Study Completion Date :||April 2023|
Experimental: Single Arm, POC
Single arm, POC Safety and Efficacy
Osimertinib 80 mg QD Abemaciclib 150mg BID
Abemaciclib 150mg BID
Osimertinib 80mg daily
- Progression Free Survival at 6 months [ Time Frame: 6 months ]Rate of Progression Free Survival at 6 months on the combination.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04545710
|Contact: Hatim Husain, MDemail@example.com|
|Contact: Sarah Moorefirstname.lastname@example.org|
|United States, California|
|UCSD Moores Cancer Center||Recruiting|
|La Jolla, California, United States, 92093|
|Contact: CTO CancerCTO@ucsd.edu|