Actively Recruiting
Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer
Led by Collin Blakely · Updated on 2024-06-10
38
Participants Needed
1
Research Sites
372 weeks
Total Duration
On this page
Sponsors
C
Collin Blakely
Lead Sponsor
P
Puma Biotechnology, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase I/Ib trial studies the side effects and best dose of alisertib when given together with osimertinib in treating patients with EGFR-mutated stage IV lung cancer. Alisertib may stop the growth of tumor cells by blocking a specific protein (Aurora Kinase A) that researchers believe may be important for the growth of lung cancer. Osimertinib may reduce tumor growth by blocking the action of a certain mutant protein (EGFR). This study may help researchers test the safety of alisertib at different dose levels in combination with osimertinib, and to find out what effects, good and/or bad, it has on EGFR-mutated lung cancer.
CONDITIONS
Official Title
Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed stage IV non-small cell lung cancer
- Male or female patients 18 years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Documented activating EGFR mutation on tumor or cell-free DNA sample
- Measurable disease by RECIST 1.1 criteria
- Adequate blood counts and organ function within 7 days before first dose
- Willingness to provide blood and tissue samples for research
- Willingness to undergo pre-treatment research biopsy or donate archived tissue
- Female patients must be postmenopausal, surgically sterile, or agree to effective contraception
- Male patients must agree to use effective barrier contraception or true abstinence
- Voluntary written consent given
- Currently receiving and tolerating osimertinib 80 mg daily without grade 2 or greater adverse events
- Evidence of disease progression on imaging within last 30 days
- Resolution of all acute toxic effects of prior treatments to grade 2 or less
- Cohort A: No more than one additional systemic therapy line besides osimertinib; must have metastatic disease or recurrence
- Cohort B: Receiving osimertinib 80 mg as first-line therapy for metastatic NSCLC, with specific response and duration criteria
- Cohort C: Same as above plus willingness for pre-treatment biopsy and no known TP53 mutations
You will not qualify if you...
- Radiation therapy to more than 25% of bone marrow
- Prior allogeneic bone marrow or organ transplant
- Gastrointestinal conditions or surgeries interfering with oral drug absorption
- Inability or unwillingness to swallow oral medication or comply with treatment
- Uncontrolled sleep apnea or severe lung disease requiring oxygen
- Requirement for continuous proton pump inhibitors or certain acid blockers during study
- Recent heart attack or severe uncontrolled heart conditions
- QTc interval greater than 470 milliseconds
- Pregnant or breastfeeding females
- Intention to donate eggs or sperm during study or 4 months after last dose
- Severe acute or chronic medical or psychiatric conditions increasing study risk
- Another cancer diagnosed or treated within 3 years, except certain low-risk types
- Use of contraindicated medications that cannot be stopped before study
- Unstable central nervous system metastases or leptomeningeal carcinomatosis
- Cohort A: Small cell lung cancer transformation or certain resistance mutations
- Cohort B: Complete response or progression on osimertinib, prior adjuvant osimertinib, or prior EGFR TKI other than osimertinib
- Cohort C: Known TP53 mutations based on biopsy testing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
L
Lisa Tan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here