Crizotinib in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Removed by Surgery and ALK Fusion Mutations (An ALCHEMIST Treatment Trial)

General Information Age Group Adults Status Recruiting Protocol Number NCT02201992 Background Information 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. Offered At Inova Schar Cancer Institute 8081 Innovation Park Drive Fairfax, VA 22031A department of Inova Fairfax Hospital Eligibility Information Patients must have undergone complete surgical resection of their stage IB (>= 4 cm), II, or non-squamous IIIA NSCLC per American Joint Committee on Cancer (AJCC) 7th edition and have had negative margins; N3 disease is not allowed Baseline chest computed tomography (CT) with or without contrast must be performed within 6 months (180 days) prior to randomization to ensure no evidence of disease; if clinically indicated additional imaging studies must be performed to rule out metastatic disease Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE A151216) trial prior to randomization Additional eligibility in protocol. Ineligibility Information No known interstitial fibrosis or interstitial lung disease No prior treatment with crizotinib or another ALK inhibitor No ongoing cardiac dysrhythmias of grade >= 2 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, uncontrolled atrial fibrillation (any grade), or corrected QT (QTc) interval > 470 msec No use of medications, herbals, or foods that are known potent cytochrome P450, subfamily 3A, polypeptide 4 (CYP3A4) inhibitors or inducers, included but not limited to those outlined Patients must be adequately recovered from surgery at the time of randomization Additional ineligibility in protocol. Additional information can be found at https://clinicaltrials.gov/ct2/show/NCT02201992 Contact Information Contact Name Mahwish Bari Contact Phone 571-472-1796 Contact Email Send Email