A Phase III Study of Crizotinib Given After Surgery for Early-Stage ALK-Positive Non-Small Cell Lung Cancer

Full 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 (ECOG-ACRIN E4512) (CIRB)

Purpose

Crizotinib is a drug approved for the treatment of metastatic non-small cell lung cancer (NSCLC) that is caused by an abnormal protein called ALK. In this study, researchers want to assess the effectiveness of crizotinib for treating earlier stages of ALK-positive NSCLC that has been surgically removed.

Patients in this study will be randomly assigned to receive either crizotinib or a placebo (inactive capsule) after lung cancer surgery. Crizotinib is taken orally (by mouth) for up to two years.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have stage IB, II, or IIIA ALK-positive NSCLC that has been surgically removed.
  • At least 2 weeks must pass since any chemotherapy or radiation therapy given after surgery and at least 4 weeks since major surgery and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Jamie Chaft at 646-888-4545.

Protocol

15-275

Phase

III

Investigator

Co-Investigators