Alisertib and Osimertinib for EGFR-mutant Lung Cancer
This study is testing a new combination of medications, alisertib and osimertinib, for people with stage IV (metastatic) lung cancer that has a specific change called an EGFR mutation. Osimertinib is a standard treatment, and alisertib is an experimental drug that may work by blocking a protein important for cancer growth. Researchers want to find the safest and most effective dose of alisertib when given with osimertinib. They will also look at how well this combination shrinks tumors and what side effects it might cause. To join, you must have stage IV non-small cell lung cancer with an EGFR mutation and be at least 18 years old. The study aims to understand the safety and preliminary effectiveness of this drug combination. The current status of this study is unclear.
- Study design
- This study is an interventional trial with a planned enrollment of 38 participants. It aims to determine the best dose and safety of alisertib when combined with osimertinib.
- What's involved
- Alisertib will be taken orally twice daily on specific days of a 28-day cycle. Osimertinib will be taken daily. The study will assess safety during the first 28 days of treatment and serious side effects for up to 2 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for serious adverse events for up to 2 years after starting treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Collin Blakely, MD, PhD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Determination of Maximum Tolerated Dose (MTD) (Cohort A)First 28 days of study treatment (1 cycle is 28 days)
The MTD is the highest dose at which no more than one instance of a dose-limiting toxicity is observed among the 6 participants treated.
- Proportion of patients experiencing dose limiting toxicity (DLT) (Cohort A)First 28 days of study treatment (1 cycle is 28 days)
Less than or at least 1 out of 6 at highest dose level below the maximal administered dose. If 0 of these 3 additional participants experience a dose limiting toxicity (DLT) (1 of 6), proceed to the next dose level. If 1 or more of the 3 additional participants experience DLT (2 of 6), then dose escalation is stopped, and this dose is declared the maximal administered dose (highest dose administered). Three (3) additional participants will be entered at the next lowest dose level if only 3 participants were treated previously at that dose.
- Proportion of patients experiencing serious adverse event (SAE)Up to 2 years
The proportion of participants experiencing an adverse event classified as an SAE will be reported by grade and type according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5, with exact 95% confidence intervals