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A Randomized Phase III Trial for Surgically Resected Early Stage Non-small Cell Lung Cancer: Crizotinib Versus Observation for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

Primary Objective: To evaluate whether adjuvant therapy with crizotinib will result in improved overall survival (OS) for patients with stage IB greater than or equal to 4cm, II and IIIA, ALK-positive NSCLC following surgical resection. Secondary Objectives: To evaluate and compare disease-free survival (DFS) associated with crizotinib To evaluate the safety profile of crizotinib when given in the adjuvant therapy setting To collect tumor tissue and blood specimens for future research.

Phase

III

Recruitment Status

Past Studies