ALCHEMIST ALK- ECOG-ACRIN E4512 for Non-Small Cell Lung Cancer

What is the Purpose of this Study?

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
What is the Condition Being Studied?
Early Stage Non-Small Cell Lung Cancer

Who Can Participate in this 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
Participating Institutions

What is Involved?

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.

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

Contacts
Protocol Number
IRB:
PRO00060199

NCT:
NCT02201992
ClinicalTrials.gov
View on ClinicalTrials.gov