None listed
Conditions
Interventions
A TOTAL OF 334 PATIENTS WILL BE RANDOMIZED IN A 1:1 RATIO TO RECEIVE CRIZOTINIB (ARM A) OR CHEMOTHERAPY PEMETREXED/CISPLATIN OR PEMETREXED/CARBOPLATIN (ARM B). THE DECISION ON THE PLATINUM CHEMOTHERAP
Sponsors
PFIZER S.A.,
Eligibility
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. HISTOLOGICALLY OR CYTOLOGICALLY PROVEN DIAGNOSIS OF LOCALLY ADVANCED NOT SUITABLE FOR LOCAL TREATMENT, RECURRENT AND METASTATIC NON-SQUAMOUS CELL CARCINOMA OF THE LUNG. 2. POSITIVE FOR TRANSLOCATION OR INVERSION EVENTS INVOLVING THE ALK GENE LOCUS (EG, RESULTING IN EML4-ALK FUSION) AS DETERMINED BY AN ALK BREAK APART FISH ASSAY AND DEFINED BY AN INCREASE IN THE DISTANCE BETWEEN 5´ AND 3´ ALK PROBES OR THE LOSS OF THE 5´ PROBE. 3. NO PRIOR SYSTEMIC TREATMENT FOR LOCALLY ADVANCED OR METASTATIC DISEASE (EXCEPTION BELOW): • PRIOR ADJUVANT CHEMOTHERAPY FOR STAGE I-III OR COMBINED MODALITY CHEMOTHERAPY RADIATION FOR LOCALLY ADVANCED DISEASE ALLOWED IF COMPLETED > 12 MONTHS PRIOR TO RANDOMIZATION. 4. PATIENTS WITH BRAIN METASTASES ARE ONLY ELIGIBLE IF TREATED AND NEUROLOGICALLY STABLE WITH NO ONGOING REQUIREMENT FOR CORTICOSTEROIDS, EG, DEXAMETHASONE, FOR AT LEAST 2 WEEKS AND ARE NOT TAKING MEDICATIONS CONTRAINDICATED IN EXCLUSION CRITERIA # 10-12. 5. ANY MAJOR SURGERIES MUST HAVE BEEN COMPLETED AT LEAST 4 WEEKS PRIOR TO INITIATION OF STUDY MEDICATION. ANY PRIOR RADIATION OR MINOR SURGERIES/PROCEDURES MUST HAVE BEEN COMPLETED AT LEAST 2 WEEKS PRIOR TO THE INITIATION OF STUDY MEDICATION. ANY ACUTE TOXICITY MUST HAVE RECOVERED TO ≤ GRADE 1 (EXCEPT ALOPECIA). 6. TUMORS MUST HAVE MEASURABLE DISEASE AS PER RECIST (VERSION 1.1).
Exclusion criteria
Exclusion criteria: 1. CURRENT TREATMENT ON ANOTHER THERAPEUTIC CLINICAL TRIAL. 2. PRIOR THERAPY DIRECTLY TARGETING ALK. 3. CARCINOMATOUS MENINGITIS, OR LEPTOMENINGEAL DISEASE. 4. SPINAL CORD COMPRESSION UNLESS TREATED WITH THE PATIENT ATTAINING GOOD PAIN CONTROL AND STABLE OR RECOVERED NEUROLOGIC FUNCTION. 5. ANY OF THE FOLLOWING WITHIN THE 3 MONTHS PRIOR TO STARTING STUDY TREATMENT: MYOCARDIAL INFARCTION, SEVERE/UNSTABLE ANGINA, CORONARY/PERIPHERAL ARTERY BYPASS GRAFT, OR CEREBROVASCULAR ACCIDENT INCLUDING TRANSIENT ISCHEMIC ATTACK. APPROPRIATE TREATMENT WITH ANTICOAGULANTS IS PERMITTED. 6. ONGOING CONGESTIVE HEART FAILURE. 7. ONGOING CARDIAC DYSRHYTHMIAS OF NCI CTCAE GRADE ≥ 2:2, UNCONTROLLED ATRIAL FIBRILLATION OF ANY GRADE, OR QTC INTERVAL >470 MSEC. 8. PERIPHERAL NEUROPATHY WITH GRADE; ≥ 1 (CTCAE VERSION 4.0). 9. KNOWN INTERSTITIAL FIBROSIS OR INTERSTITIAL LUNG DISEASE. 10. PREVIOUS TREATMENT WITH CRIZOTINIB. 11. PREGNANCY OR BREASTFEEDING. 12. USE OF DRUGS OR FOODS THAT ARE KNOWN POTENT CYF3A4 INHIBITORS INCLUDING BUT NOT LIMITED TO AMPRENAVIR, ATAZANAVIR, CLARITHROMYCIN, DELAVIRDINE, DILTIAZEM, ERYTHROMYCIN,INDINAVIR, ITRACONAZOLE, KETOCONAZOLE, MICONAZOLE, NEFAZODONE, NELFINAVIR, RITONAVIR, SAQUINAVIR, TELITHROMYCIN, TROLEANDOMYCIN, VERAPAMIL, VORICONZOLE, AND GRAPEFRUIT OR GRAPEFRUIT JUICE.
Countries
Australia, Austria, Belgium, Brazil, Canada, Chile, China, Finland, France, Germany, India, Ireland, Italy, Japan, Korea North, Luxembourg, Mexico, Netherlands, Norway, Portugal, Russian Federation, Singapore, South Africa, Spain, Switzerland, Taiwan, Ukraine, United Kindgdom, United States
Outcome results
None listed