ECOG-ACRIN E4512 for Non-Small Cell Lung Cancer - 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
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
View on ClinicalTrials.gov