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E4512 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
Protocol Number:
Phase III
Patrick Forde
Johns Hopkins Kimmel Cancer Center in Baltimore
Sibley Memorial Hospital
Johns Hopkins Bayview Medical Center
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.
You are being asked to take part in this research study because you have ALK-positive non-small cell lung cancer, which has been removed by a surgeon.
Eligible patients will be randomly assigned, like a flip of a coin, to receive the study drug crizotinib or a placebo, a pill with no medicine. Participants will continue to take their study agent by mouth twice a day for up to two years. After you finish taking crizotinib/placebo, your doctor will continue to watch you for side effects and follow your condition for up to 10 years.
Last Update
08/08/2020 05:02 AM