Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer

PHASE1RecruitingINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

November 12, 2019

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Lung Cancer MetastaticEGFR Gene Mutation
Interventions
DRUG

Osimertinib

Osimertinib is a medication used to treat non-small-cell lung carcinomas with a specific mutation. It is a third-generation epidermal growth factor receptor tyrosine kinase inhibitor. Patients will be receiving full dose osimertinib (80 mg PO daily) as part of the patient's current standard of care.

DRUG

Alisertib

Alisertib is an orally available selective aurora A kinase inhibitor. Alisertib will be administered to eligible patients in combination with osimertinib at doses ranging from 20 mg to 50 mg PO twice daily on days 1-3, 8-10, and 15-17 of a 28-day cycle. The starting alisertib dose for Cohort 1 will be 30 mg twice daily (dose level 1).

Trial Locations (1)

94143

RECRUITING

University of California, San Francisco, San Francisco

All Listed Sponsors
collaborator

Puma Biotechnology, Inc.

INDUSTRY

lead

Collin Blakely

OTHER