RecruitingPhase 2NCT04084717

Study of Crizotinib for ROS1 and MET Activated Lung Cancer

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

Sponsor

University Health Network, Toronto

Enrollment

50 participants

Start Date

Dec 3, 2019

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests crizotinib — a targeted therapy pill — in patients with advanced lung cancer that has a specific genetic change (a ROS1 rearrangement or a MET gene mutation or amplification). These genetic changes cause the cancer to grow, and crizotinib is designed to block them. **You may be eligible if...** - You are 18 or older - You have stage IV (advanced) non-squamous non-small cell lung cancer - Your tumor has a confirmed ROS1 rearrangement, MET exon 14 mutation, or MET amplification - You can swallow pills and have no major gut absorption problems - You are not pregnant and agree to use contraception **You may NOT be eligible if...** - You have untreated brain metastases causing symptoms - You received chemotherapy or targeted therapy within the past 4 weeks, or radiation within the past 2 weeks - You have a heart condition called long QT syndrome or an abnormal heart rhythm reading (QTcF ≥ 500 msec) - You are taking certain medications that strongly interact with crizotinib Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCrizotinib

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.

Locations(1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

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NCT04084717

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