OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) announced today that it has completed enrollment in the RADIANT study, a Phase III clinical trial testing Tarceva
(erlotinib) as an adjuvant therapy in patients with Stage IB-IIIA non-small cell lung cancer (NSCLC) who have undergone surgery and have EGFR-positive tumors. RADIANT is an international, randomized, double-blinded, placebo-controlled Phase III study that has reached its enrollment goal of 945 patients. The primary objective of the study is to determine whether the targeted therapy Tarceva prolongs disease-free survival when given as an adjuvant therapy. This is defined as a cancer treatment that is given after the primary treatment, which is typically surgery or surgery and chemotherapy in this group of NSCLC patients, to lower the risk of the cancer coming back.
“We believe an oral therapy like Tarceva can be a valuable addition to the treatment paradigm by extending the disease-free survival of patients with Stage Ib-IIIa NSCLC,” said Colin Goddard, Ph.D., Chief Executive Officer of OSI Pharmaceuticals. “The study has received considerable interest from both investigators and patients and we look forward to the potential for interim results in 2012 and final results in 2013-2014.”
RADIANT is being conducted at approximately 240 sites in the United States, Canada, Western and Eastern Europe, Asia Pacific and Argentina. The study enrolled patients with surgically removed Stage IB-IIIA NSCLC who have EGFR-positive tumors, as expressed by immunohistochemistry (IHC) and/or fluorescence in-situ hybridization (FISH), and who had completed up to four cycles of standard adjuvant platinum-based chemotherapy or were chemotherapy naive. Patients were randomized 2:1 to receive either Tarceva 150 mg or placebo once daily for two years.
The primary objective of RADIANT is to evaluate the effectiveness of adjuvant therapy with Tarceva in prolonging disease-free survival. Secondary objectives of the study include comparing overall survival between study arms, evaluating the safety of adjuvant Tarceva therapy, and exploring the predictive value of EGFR-related biomarkers that may be associated with clinical outcomes following treatment with Tarceva.