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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
The purpose of this research study is to compare any good and bad effects of using the study drug, crizotinib (also known as XALKORI), after completion of surgery and, in some cases, after chemotherapy and/or radiation therapy for ALK-positive non-small cell lung cancer.
1 Primary Objective: To evaluate whether adjuvant therapy with crizotinib will result in improved Overall Survival (OS) over placebo for patients with stage IB >/= 4cm, II and IIIA, ALK-positive NSCLC following surgical resection. 2 Secondary Objectives: 2.1 To evaluate and compare Disease-free Survival (DFS) associated with crizotinib and placebo. 2.2 To evaluate the safety profile of crizotinib when given in the adjuvant therapy setting. 2.3 To collect tumor tissue and blood specimens for future research.