Clinical Trial TitleA 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.
Clinical Trial Protocol Description:
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. The addition of crizotinib may help prevent your cancer from returning, but it could also cause side effects. This research study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. You will have an equal (50%) chance of being placed in either group. You will receive the crizotinib/placebo twice a day for up to two (2) 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.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have previously registered to A151216 and positive for translocation or inversion events involving the ALK gene locus.
- Have complete surgical resection of stage IB (>= 4 cm), II, or non-squamous IIIA NSCLC and have had negative margins.
- Have no prior treatment with crizotinib or another ALK inhibitor.
This is a partial list of elgibility requirements.