Crizotinib in Treating Patients with Stage IB-IIIA Non-small Cell Lung Cancer That has Been Removed by Surgery and ALK Fusion Mutations (An ALCHEMIST Treatment Trial)
Active Date:
September 01, 2014
IRB Number:
ALCHEMIST (E4512)
Condition/Disease:
Lung Cancer
Lead Researcher:
Maria Quejada, MD
Location:
Edward Cancer Center - Naperville
Purpose:
This randomized phase III trial studies how well crizotinib works vs observation in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called ALK. Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Tumors with this mutation may respond to treatments that target the mutation, such as crizotinib. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. It is not yet known if crizotinib may be an effective treatment for treating non-small cell lung cancer with an ALK fusion mutation.
Sponsor: Eastern Cooperative Oncology Group (ECOG)
https://clinicaltrials.gov/ct2/show/NCT02201992?term=alchemist&rank=4
Eligibility:
Previously registered to A151216 and have undergone complete resection
Patients must NOT have uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
No prior treatment with crizotinib or another ALK inhibitor
Patients must be adequately recovered from surgery at the time of randomization. The minimum time between date of surgery and randomization must be at least 28 days and no more than 90 days if no adjuvant chemotherapy was administered, 180 days if adjuvant chemotherapy was administered, or 240 days if adjuvant chemotherapy and radiation therapy were administered
Patients must have completed any prior chemotherapy or radiation therapy 2 or more weeks (6 or more weeks for mitomycin and nitrosoureas) prior to randomization and be adequately recovered at the time of randomization
Patients must not have any history of cancer within 2 years from randomization, with the exception of in-situ carcinoma of the cervix or completely resected non-melanoma skin cancer
Time Commitment:
10-12 years
Status:
Accepting Participants
Current Trial Type:
Interventional
Phase:
III
Contact Name:
Kathy Seymour, BSN
Phone:
630-646-6075
Fax:
630-646-6110
Alternate Phone:
630-646-6072