ABOUT THIS STUDY
- 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).
- 18 years of age or older.
- Measurable disease as per RECIST v1.1.
- Adequate hematologic, cardiac and organ function within 7 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
- Symptomatic untreated brain metastases.
- Had chemotherapy (including investigational cytotoxic chemotherapy), biologic agents
(e.g. targeted therapy or antibodies) or radiotherapy within 4 weeks prior to the
proposed first dose of study treatment.
- Adverse events attributed to prior anti-cancer therapy > Grade 1 if clinically
- Receiving medications or substances known to be strong inhibitors or inducers of
- 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
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- Toronto, Ontario