Actively Recruiting
Phase II Study of Crizotinib for ROS1 and MET Activated Lung Cancer (CROME)
Led by University Health Network, Toronto · Updated on 2024-07-16
50
Participants Needed
1
Research Sites
26 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
Researchers are studying crizotinib, an oral chemotherapy drug, in people with metastatic non-small cell lung cancer that has specific genetic changes called ROS1 rearrangement or MET mutations. This phase 2 study aims to evaluate how well crizotinib works for treating these types of lung cancer. Crizotinib is already approved for certain advanced lung cancers with ALK or ROS1 mutations. The study includes a screening period to confirm eligibility through tests and procedures. Eligible participants then take crizotinib orally at a dose of 250 mg twice daily in 28-day cycles. The study has three groups based on the type of genetic mutation: ROS1 rearrangement, MET-activating mutation (exon 14), or MET amplification. Participants attend weekly visits for safety and research assessments during treatment. After stopping the drug, they have an end-of-treatment visit about 28 days later and receive follow-up imaging every 8 weeks if they stop treatment for reasons other than cancer progression. The study nurse will also call participants every 3 months after the final visit to check on their health. Participants will undergo regular safety tests, imaging scans, and questionnaires about symptoms and quality of life during the study. Researchers will measure response rate, progression-free survival, time to treatment failure, symptom scores, quality of life, and overall survival over up to five years. Safety monitoring continues after treatment stops, with close follow-up if side effects occur. The total involvement includes screening, treatment, follow-up visits, and long-term health status calls.
CONDITIONS
Brief 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 stage IV or incurable non-squamous non-small cell lung cancer with ROS1 rearrangement, MET-activating mutation (exon 14), or MET amplification
- 18 years of age or older
- Measurable disease per RECIST v1.1 criteria
- Adequate blood counts and organ function within 7 days before treatment start
- Adequate heart function within 28 days before treatment start
- Life expectancy greater than 12 weeks
- Able to understand and willing to sign informed consent
- ECOG performance status of 0, 1, or 2
- No contraindications to crizotinib therapy
- Able to swallow and retain oral medication without significant gastrointestinal issues
- Not pregnant and agreeing to use contraception during and for 120 days after treatment
You will not qualify if you...
- Symptomatic untreated brain metastases
- Received chemotherapy, biologic agents, or radiotherapy within 4 weeks (chemotherapy/biologic) or 2 weeks (radiotherapy) before starting study drug
- Adverse events from prior anti-cancer therapy greater than Grade 1 if clinically relevant
- Taking medications known to strongly affect CYP3A4 enzyme activity
- Known intolerance to drugs similar to crizotinib
- Congenital long QT syndrome or QTcF interval 500 msec or longer
- Any other condition that may pose safety risks or interfere with study compliance, such as infection, intestinal obstruction, inability to swallow medication, or social/psychological issues
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Several visits for tests and procedures
Duration - Each 28 day cycle, repeated until disease progression or discontinuation
Participants take the study drug Crizotinib and have tests and procedures done weekly for safety and research purposes.
Approximately weekly visits
Duration - About 28 days
Participants who stop the study drug return about 28 days after their last dose for safety and research tests and procedures.
1 visit (in-person)
Duration - Until disease progression or new treatment, then ongoing health checks
Participants who discontinue study drug without disease progression have imaging every 8 weeks until progression or new treatment, followed by health status calls every 3 months.
Imaging every 8 weeks and calls every 3 months
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.
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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