Clinical Trial: Cancer, Lung Cancer

Lung Cancer E4512: A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients w/ Tumors Harboring the ALK Fusion Protein

Full Name

A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib Versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

Description

If you choose to participate in this study, you will be assigned to one of two study groups. Those assigned to Group 1 will receive the study drug, crizotinib. Those assigned to Group 2 will receive a placebo (looks like the study drug, but contains no active ingredient). Neither you nor your study doctor will know to which group you are assigned until after you have completed treatment. However, in an emergency, your study doctor can find out. You will receive the crizotinib/placebo twice a day for up to two years. After you have finished taking the crizotinib/placebo, your doctor will continue to watch you for side effects and follow your condition for up to 10 years. You will have the following examinations/tests to see if you can be in the study: Electrocardiogram (EKG) to check your heart rhythm, Blood or urine pregnancy test if you are a woman of childbearing potential, smoking status survey, and ALK Fusion Status test using tissue from your previous surgery and/or biopsies. You will have toxicity assessments every 3 weeks for the first 12 weeks, then every 6 weeks until 30 days after you stop taking the drug, to see if you are experiencing any side effects.

Eligibility

Inclusion Criteria
Must be greater than or equal to 18 years of age Must have undergone complete surgical resection of your Stage IB, II or non-squamous IIIA non-small cell lung cancer, and have negative margins Must have ECOG Performance Status of 0 or 1 Must not have had any prior treatment with crizotinib or another ALK inhibitor Must have adequate organ function Must not be receiving any other investigational drugs while on this study
Doctor(s) Running This Study