The clinical trial, which was sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, was designed to compare AstraZeneca’s Iressa (gefitinib) to placebo following chemotherapy and radiation for patients with non-small cell lung cancer (NSCLC) that had spread only to nearby tissues or lymph nodes.
Based on a review of the limited data available from the phase III clinical trial, the data monitoring committee overseeing the trial recommended the closure, as the trial would not meet its primary endpoint of improved survival.
“The interim analysis indicates that even with accrual of more patients or with longer follow-up, the gefitinib arm would not improve survival,” said Laurence Baker, chairman of the Southwest Oncology Group (SWOG) and professor of internal medicine and pharmacology at the University of Michigan in Ann Arbor.
The analysis did confirm, however, the favorable survival seen with the chemotherapy and radiation regimen previously reported by SWOG, and thus patients currently entered in the trial are being advised to complete this part of their treatment.