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E4512- A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein
Purpose of this study is to compare any good and bad effects of using the study drug, crizotinib after completeion of surgery and in some cases after chemotherapy and/or radiation therapy for ALK-positive non-small cell lung cancer.
You will need to have the following extra exams and tests to find out if you can be in the research study:•Electrocardiogram (EKG) to check your heart rhythm•Blood or urine pregnancy test, if you are a woman of child-bearing potential•Smoking status survey•ALK Fusion Status test using tissue from your previous surgery and/or biopsiesToxicity assessment will be done every 3 weeks for the first 6 weeks, then every 6 weeks for the next 12 weeks, then every 12 weeks until treatment is completed.
Yes
Michelle Eschbach - at meschbach@pennstatehealth.psu.edu or 610-378-2336
Cancer Institute (ST. JOSEPH)
All
18 year(s) or older
NCT02201992
AFFIL000E4512
Inclusion Criteria:
Patients must have undergone complete surgical resection of theirPatients must be registered to the ALCHEMIST-SCREEN (ALLIANCE
ALK positive
Patients must have completed any prior adjuvant chemotherapy or
Exclusion Criteria:
No prior treatment with crizotinib or another ALK inhibitor. Cancer