Description:
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.
Title
- Brief Title: Study of Crizotinib for ROS1 and MET Activated Lung Cancer
- Official Title: Phase II Study of Crizotinib for ROS1 and MET Activated Lung Cancer (CROME)
Clinical Trial IDs
- ORG STUDY ID:
18-5607
- SECONDARY ID:
CROME / WI235747
- NCT ID:
NCT04084717
Conditions
- Non-squamous Non-small-cell Lung Cancer
- Stage IV Non-small Cell Lung Cancer
- ROS1 Gene Rearrangement
- MET Activating Mutation
- MET Amplification
Interventions
Drug | Synonyms | Arms |
---|
Crizotinib | XALKORI | MET-activating Mutation (exon 14) |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
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. | |
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. | |
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. | |
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of stage IV or incurable
non-squamous non-small cell lung cancer with a documented ROS1 rearrangement (cohort
1) or MET-activating mutation (exon 14) (cohort 2) or MET-amplification (cohort 3)
tested in either plasma or tissue, as applicable
- 18 years of age or older.
- Measurable disease as per RECIST v1.1.
- Adequate hematologic and organ function within 7 days of the proposed start date of
treatment and adequate cardiac function within 28 days of the proposed start date of
treatment
- Life expectancy >12 weeks.
- Have the ability to understand and the willingness to sign a written informed consent
document
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- No contraindication to Crizotinib therapy
- Able to swallow and retain oral medication and does not have any clinically
significant gastrointestinal abnormalities that may alter absorption such as
malabsorption syndrome or major resection of the stomach or bowels.
- No pregnant
- Agree to use methods (as agreed upon by the study doctor and participant) before the
study and for at least 120 days after the last dose of study drug to prevent pregnancy
Exclusion Criteria:
- Symptomatic untreated brain metastases.
- Had chemotherapy (including investigational cytotoxic chemotherapy), biologic agents
(e.g. targeted therapy or antibodies) within 4 weeks or radiotherapy within 2 weeks
prior to the proposed first dose of study treatment.
- Adverse events attributed to prior anti-cancer therapy > Grade 1 if clinically
relevant.
- Receiving medications or substances known to be strong inhibitors or inducers of
CYP3A4.
- Any known intolerance to agents structurally similar to crizotinib.
- Congenital long QT syndrome or persistent corrected QT interval by Fredericia formula
(QTcF) ≥ 500 msec.
- Any other condition that would, in the Investigator's judgment, contraindicate the
patient's participation in the clinical study due to safety concerns or compliance
with clinical study procedures, e.g., infection/inflammation, intestinal obstruction,
unable to swallow medication, social/ psychological issues
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Response Rate |
Time Frame: | 5 years |
Safety Issue: | |
Description: | Via RECIST 1.1 |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | University Health Network, Toronto |
Last Updated
April 1, 2021