Clinical Trial Details

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 (E4512)

Categories (click each to see list of all clinical trials associated with that category): Thoracic (ONC)

Current Status: Open

Phase: III

Principal Investigator: Ganti, Apar

Contact Information:
Sarah Kirke, RN
402-559-8065
sarah.kirke@unmc.edu

Eligibility: https://clinicaltrials.gov/ct2/show/NCT02201992#eligibility

Summary
PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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.