Actively Recruiting
Study of Crizotinib for ROS1 and MET Activated Lung Cancer
Led by University Health Network, Toronto · Updated on 2024-07-16
50
Participants Needed
1
Research Sites
286 weeks
Total Duration
On this page
Sponsors
U
University Health Network, Toronto
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Crizotinib for ROS1 and MET Activated Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed diagnosis of stage IV or incurable non-squamous non-small cell lung cancer with a documented ROS1 rearrangement or MET-activating mutation or MET-amplification tested in plasma or tissue
- 18 years of age or older
- Measurable disease according to RECIST v1.1
- Adequate blood and organ function within 7 days before treatment start and adequate heart function within 28 days before treatment start
- Life expectancy greater than 12 weeks
- Ability to understand and willingness to sign informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- No contraindication to crizotinib therapy
- Ability to swallow and retain oral medication without significant gastrointestinal problems
- Not pregnant
- Agreement to use pregnancy prevention methods before and for at least 120 days after last dose of study drug
You will not qualify if you...
- Symptomatic untreated brain metastases
- Chemotherapy, biologic agents, or radiotherapy within 4 weeks or 2 weeks before first dose of study treatment
- Adverse events from prior anti-cancer therapy greater than Grade 1 if clinically relevant
- Taking medications known to strongly affect CYP3A4 enzyme
- Known intolerance to agents similar to crizotinib
- Congenital long QT syndrome or corrected QT interval (QTcF) 500 msec or more
- Any condition judged by the investigator to contraindicate participation due to safety or compliance concerns, such as infection, intestinal obstruction, inability to swallow medication, or social/psychological issues
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Trial Site Locations
Total: 1 location
1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 1Z5
Actively Recruiting
Research Team
N
Natasha Leighl, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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