PCRC_E4512

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

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive crizotinib orally (PO) twice daily (BID) on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive placebo PO BID on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then yearly for 5 years.
Phase III
NCT02201992
Oncology
Lung
Alison Conlin, M.D.
ECOG
Brenda Fisher

The Pacific Cancer Research Consortium clinical trials are offered at multiple locations throughout Oregon, Washington, Alaska, California, and Idaho. To find a location near you, please contact the Patient Engagement Center at 844-552-2734.