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ECOG-ACRIN E4512 - Clinical Trial

What is the Purpose of this Study?

We are doing this study to see if giving the study drug Crizotinib after surgery (or chemotherapy and/or radiation therapy) will help prevent the cancer from returning.

What is the Condition Being Studied?

Early Stage Non-Small Cell Lung Cancer

Who Can Participate in the Study?

Adults with non-small cell lung cancer who:
- Have complete surgical resection of their cancer
- Have had no prior treatment with crizotinib
- Are not pregnant or nursing

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Be randomized (like the flip of a coin) to get either:
-- Group 1: The study drug crizotinib twice a day for up to 2 years
-- Group 2: Be followed for observation for up to 10 years
- Get CT scans every 6 months if less than 4 years from study entry and then every 12 months for up to 10 years from study entry

Study Details

Full Title
ECOG-ACRIN E4512: A 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
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00060199
NCT:NCT02201992
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698