YM BioSciences, an oncology product development company, has enrolled the first patient into its multinational trial of nimotuzumab for the treatment of patients with non-small-cell lung cancer.
This Phase II randomized, double-blind, placebo-controlled study will examine the effect of nimotuzumab when added to palliative radiotherapy to treat non-small-cell lung cancer (NSCLC).
The trial has a target enrollment of 128 patients and is being conducted internationally with 12 centers contracted to participate in Canada. Patients diagnosed with stage IIb or III NSCLC ineligible for curative treatment, or stage IV NSCLC patients with progressive disease within the chest, are eligible to enroll into this study. This trial is being launched subsequent to a successful lead-in Phase I trial in a similar patient population.
The trial enrolment is anticipated to take 18 months and a follow-up period of 18 months will be required to complete the trial. The primary endpoint of the trial is to evaluate the difference in OS with secondary endpoints being Response Rate, Time to Progression, Progression-Free Survival and Quality of Life.
David Allan, chairman and CEO of YM BioSciences, said: This trial is one of two that we are launching in indications in which nimotuzumab’s demonstrated and differentiated mechanistic attributes are expected to show that it is as effective as the currently marketed antibodies while continuing to demonstrate its best-in-class prospect.