NCT04084717

Study of Crizotinib for ROS1 and MET Activated Lung Cancer

Phase II Study of Crizotinib for ROS1 and MET Activated Lung Cancer (CROME)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2 study of a drug called crizotinib in people with metastatic (the cancer has spread to other parts of the body) non-small cell lung cancer with a mutation (change) in genes called ROS1 or MET. The purpose of this study is to look at how effective crizotinib is at treating ROS1 or MET mutated non-small cell lung cancer. Crizotinib, also called XALKORI, is a chemotherapy drug that is currently approved for the treatment of ALK- or ROS1- positive advanced non-small cell lung cancer.

Detailed description

The study consists of a screening period, study drug period, end of study drug visit and follow-up period. During the screening period, participants will be asked to have tests and procedures done to make sure that they are eligible to continue in the study. Screening may take several visits. Participants found to be eligible to continue in the study, will then enter the study drug period where they will take the study drug and have tests and procedures done about once a week for safety and for research purposes. Participants who stop the study drug completely for any reason, will be asked to return to the clinic for an end of study drug visit about 28 days after their last dose of study drug to have tests and procedures done for safety and for research purposes. Participants that are experiencing any side effects during this time, will be closely followed by their study Doctor until the side effects have resolved or stabilized. Participants who discontinue study drug for any reason other than disease progression, will be asked to have radiological imaging every 8 weeks to follow up on the status of their disease, until disease progression or the start a new treatment for their cancer. After their final visit, the study nurse will call participants approximately every 3 months to check on the status of their health.

Conditions

• Non-squamous Non-small-cell Lung Cancer
• Stage IV Non-small Cell Lung Cancer
• ROS1 Gene Rearrangement
• MET Activating Mutation
• MET Amplification

Interventions

Type	Name	Description
DRUG	Crizotinib	Crizotinib is an orally administered, chemotherapy drug that works by blocking ALK, MET and ROS1 receptor tyrosine kinases from working. Participants will receive crizotinib, orally (by mouth), at a dose of 250 mg, twice per day, every day of each 28 day cycle.

Timeline

• Start date: 2019-12-03
• Primary completion: 2024-12-01
• Completion: 2025-06-01
• First posted: 2019-09-10
• Last updated: 2024-07-16

Locations

1 site across 1 country: Canada