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| ID | Type | Description | Link |
|---|---|---|---|
| CROME / WI235747 | Other Identifier | Princess Margaret Cancer Centre |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ROS1 Rearrangement | Experimental | Patients with stage IV or incurable non-squamous non-small cell lung cancer with a documented ROS1 rearrangement will be assigned to this arm. |
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| MET-activating Mutation (exon 14) | Experimental | Patients with stage IV or incurable non-squamous non-small cell lung cancer with a documented MET-activating mutation (exon 14) will be assigned to this arm. |
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| MET-amplification | Experimental | Patients with stage IV or incurable non-squamous non-small cell lung cancer with a documented MET-amplification will be assigned to this arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crizotinib | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | Via RECIST 1.1 | 5 years |
| Progression-free survival | Via RECIST 1.1 | 5 years |
| Average Time-to-treatment Failure | Time from randomization to treatment discontinuation for any reason | 5 years |
| Edmonton Symptom Assessment Scale (ESAS) Score | Patient related symptom improvement evaluated by ESAS | 5 years |
| EQ5D-5L Questionnaire Score | Patient preference/health related utility evaluated by EQ5D-5L Questionnaire | 5 years |
| Overall survival | Number of days from the date of randomization to the date of death | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natasha Leighl, M.D. | Princess Margaret Cancer Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 1Z5 | Canada |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000077547 | Crizotinib |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000631 | Aminopyridines |
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Participants will be assigned to one of the following:
Cohort 1 - ROS1 rearrangement Cohort 2 - MET-activating mutation (exon 14) Cohort 3 - MET-amplification
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011725 |
| Pyridines |