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Title:
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:
NCTNE4512
Phase:
Phase III
Physician:
Patrick Forde
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Sibley Memorial Hospital
Johns Hopkins Bayview Medical Center
Purpose:
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.
Eligibility:
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.
Treatment:
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.
Population:
Adult
Last Update
03/05/2019 05:03 AM