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This study evaluates the drug Crizotinib in East Asian patients with advanced or metastatic non-small cell lung cancer that is ROS1-positive but ALK-negative. It included patients with confirmed ROS1-positive, ALK-negative disease. It was a Phase 2 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
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Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic * treatment-naïve or have received no more than 3 systemic treatment regimen(s) * Positive for translocation or inversion events involving the ROS1 gene * Negative for translocation or inversion events involving the ALK gene * Patients with brain metastases are eligible if asymptomatic, or if treated, must be neurologically stable for at least 2 weeks and are not taking any contraindicated medications * Any prior treatment (chemotherapy, radiation \[except for palliative\], or surgery) must have been completed at least 2 weeks prior to initiation of study medication * At least 1 measurable tumor lesion as per RECIST v1.1 * Female or male, 18 years of age or older * ECOG performance status 0 to 1 * Adequate organ function * Signed and dated informed consent * Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including completion of the PRO measures * Agree to use effective contraception during the study period and for at least 90 days after completion of the study treatment Exclusion Criteria: * Current treatment on another therapeutic clinical trial * Prior therapy specifically directed against ALK or ROS1 fusion genes * Spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function, carcinomatous meningitis, or leptomeningeal disease * known interstitial fibrosis or interstitial lung disease * myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack within 3 months prior to start of study treatment * Ongoing cardiac dysrhythmias of NCI CTCAE v4.03 Grade \>/=2, uncontrolled atrial fibrillation of any grade, or QTc \>470 msec * Pregnant or breast feeding * Use of drugs or foods that are known potent CYP3A4 inhibitors or inducers * Use of other anti-cancer drugs including traditional Chinese medicine on the SFDA list * Evidence of active malignancy within last 3 years