Development Status
Stimuvax® is currently being evaluated in a Phase 3 clinical trial for the treatment of non-small cell lung cancer (NSCLC). The global START (Stimulating Targeted Antigenic Responses To NSCLC) Trial is designed to assess the efficacy and safety of Stimuvax® as a potential treatment for patients with unresectable stage III non-small cell lung cancer (NSCLC). The START trial is a randomized, double-blind, placebo-controlled study that will evaluate patients with documented unresectable stage III NSCLC who have had a response or stable disease after at least two cycles of platinum based chemo-radiotherapy. The study has been designed considering scientific advice from the European Medicines Agency (EMEA/CHMP) and has been agreed upon with the U.S. Food and Drug Administration (FDA) through a Special Protocol Assessment (SPA).
The START trial is expected to include more than 1,300 patients in approximately 30 countries. Currently, there are no approved maintenance therapies for patients responding to first-line treatment for unresectable stage III NSCLC.
Patients interested in potentially participating in the Phase 3 study of Stimuvax® should call 1-800-507-5284 or visit www.nsclcstudy.com.
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