Study ID: E4512
A randomized phase 3 trial for surgically resected early-stage non-small cell lung cancer (NSCLC): crizotinib vs. observation for patients with tumors harboring the anaplastic lymphoma kinase (ALK) fusion protein
This treatment trial seeks to determine the efficacy of the oral drug crizotinib for patients who have been diagnosed with NSCLC and whose tumors have tested positive for the ALK gene. Some participants in this study will take crizotinib orally twice daily for 21 days of treatment scheduled for 2 years, if tolerated.
- Registered to A151216 prior to randomization, must have ALK rearrangement
- Adequately recovered from surgery at time of randomization (see protocol for details)
- Completed any prior adjuvant chemotherapy/RT two or more weeks (six or more weeks for mitomycin/nitrosoureas) prior to randomization and be adequately recovered
- Baseline chest CT performed within 60 days of randomization
- Crizotinib (250 mg PO BID, days 1-21) or observation
- Patients randomized to crizotinib treatment will be treated for up to two years.
Treatment will be discontinued at disease progression or excessive toxicity.
- Must have been diagnosed with NSCLC with tumors positive for the ALK gene
- Must have undergone surgical resection
- Must have completed chemotherapy or radiation therapy at least two weeks prior to registration
- Must have a baseline chest CT scan performed