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ECOG 4512: 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) over placebo for patients with stage IB ? 4cm, II and IIIA, ALK-positive NSCLC following surgical resection.

Secondary objectives:
1. To evaluate and compare disease-free survival (DFS) associated with crizotinib and placebo
2. To evaluate the safety profile of crizotinib when given in the adjuvant therapy setting
3. To collect tumor tissue and blood specimens for future research.

Protocol Number: 031502
Phase: Phase III
Applicable Disease Sites: Lung
Drugs Involved: Crizotinib
Principal Investigator: Joseph Aisner M.D.
Scope: National
Therapies Involved: Chemotherapy single agent systemic
Participating Institutions:
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria. For additional information on this trial or other available clinical trials please contact the research nurse.

For further information about clinical trials, please contact us at 732-235-7356.