Last updated on July 2019

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


Brief description of study

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

Detailed Study 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, adding crizotinib after standard treatment, is better, the same, or worse than the usual approach. In order for this new treatment regimen to be considered to be better, the study drug needs to improve how long study subjects live by 2 years and 9 months (33 months total) or more compared to the usual approach. The study drug, crizotinib, is already FDA-approved for use in ALK-positive locally advanced or metastatic (spread to other areas of the body) non-small lung cancer. The use of crizotinib in this study is investigational (not approved by the FDA) because crizotinib (or placebo) will be prescribed for earlier stage disease after the cancer has been surgically removed. A placebo is a capsule that looks like the study drug but contains no medication.

Patients taking low dose Methotrexate for non-malignant conditions and other cytotoxic agents for non-malignant conditions are allowed to continue treatment while on study

Clinical Study Identifier: TX140442

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