A Phase I/II Study of Ibrutinib in Previously Treated Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title: A Phase I/II Study of Ibrutinib in Previously Treated Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer

Status Completed

Clinical Trial Summary

The goal of Part 1 of this clinical research study is to find the highest dose of (Imbruvica) ibrutinib that can be given to patients with non-small cell lung cancer (NSCLC). The goal of Part 2 of this clinical research study is to learn if the dose of ibrutinib found in Part 1 can help to control the disease.

The safety of this drug will also be studied in both parts of the study.

Clinical Trial Description

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 4 groups of up to 6 participants will be enrolled in Part 1 of the study, and up to19 participants will be enrolled in Part 2.

If you are enrolled in Part 1, the dose of ibrutinib you receive will depend on when you join this study. The first group of participants will receive the lowest dose level of ibrutinib. Each new group will receive a higher dose of ibrutinib than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of ibrutinib is found.

If you are enrolled in Part 2, you will receive ibrutinib at the highest dose that was tolerated in Part 1.

Study Drug Administration:

You will take ibrutinib pills 1 time each day, at about the same time every day. You may take your dose of ibrutinib with or without food.

Study Visits:

Each cycle is 4 weeks.

On Day 1 of all cycles:

• You will have a physical exam

• Blood (about 3 teaspoons) will be drawn for routine tests.

• On Cycle 2 only, blood (about 1 teaspoon each time) will be drawn for pharmacokinetic (PK) testing before your dose and then 4 more times over the next 6 hours after your dose. PK testing measure the amount of study drug in the body at different timepoints.

• If you the doctor thinks it is needed, blood (about ½ teaspoon) or urine will be collected for pregnancy testing.

Every 8 weeks, you will have a CT, MRI, or x-ray to check the status of the disease. You will have the same type of scan performed as you did at screening.

Length of Study:

You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over after the follow-up visits.

End-of-Dosing Visit:

About 30 days after your last dose of study drug:

• You will have a physical exam.

• Blood (about 3 teaspoons) will be drawn for routine tests.

• If you the doctor thinks it is needed, blood (about ½ teaspoon) or urine will be collected for pregnancy testing.

Follow Up Visits:

Every 6 months you will be asked to come into the clinic or you will be called by a member of the study staff to ask how you are doing and if you have started any new anti-cancer treatments. If you are called, it should take about 10 minutes.

This is an investigational study. Ibrutinib is FDA approved and commercially available for the treatment of chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). It is considered investigational to use this drug to treat NSCLC. The study doctor can explain how the study drug is designed to work.

Up to 43 participants will be enrolled on this study. All will take part at MD Anderson. ;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

• NCT number: NCT02321540
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 31, 2015
• Completion date: September 16, 2021