This randomized phase III trial studies how well crizotinib works in treating patients with
stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation
in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make
it very active and important for tumor cell growth and progression. Crizotinib may stop the
growth of tumor cells by blocking the ALK protein from working. Crizotinib may be an
effective treatment for patients with non-small cell lung cancer and an ALK fusion mutation.
I. To evaluate whether adjuvant therapy with crizotinib will result in improved overall
survival (OS) for patients with stage IB >= 4 cm, II and IIIA, ALK-positive non-small cell
lung cancer (NSCLC) following surgical resection.
I. To evaluate and compare disease-free survival (DFS) associated with crizotinib.
II. To evaluate the safety profile of crizotinib when given in the adjuvant therapy setting.
III. To collect tumor tissue and blood specimens for future research.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive crizotinib orally (PO) twice daily (BID) on days 1-21. Treatment
repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable
ARM B: Patients undergo observation.
After completion of study treatment, patients are followed up every 6 months if < 4 or 5
years from study entry, and every 12 months if 5-10 or 6-10 years from study entry.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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