CTSU E4512

Official Title

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

Study Purpose

To compare any good and bad effects of using the study drug, crizotinib, after completion of surgery and, in some cases, after chemotherapy and/or radiation therapy for ALK-positive non-small cell lung cancer.

Diagnosis

Eligibility

Previously registered to ALCHEMIST SCREEN A151216.

ECOG performance status 0 or 1.

Complete surgical resection with negative margins.

Positive for translocation or inversion events involving the ALK gene locus.quate hematologic and end-organ function.

No prior treatment with Crizotinib or other ALK inhibitor.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Intervention

• Study agents: Crizotinib vs observation
• Crizotinib will be taken orally twice daily until recurrence, intolerability or for up to 2 years.
• Assessments will be completed every 3 weeks then 6 weeks, then every 12 weeks.
• CT scans will be every 6 months.