Tarceva study protocol change

OSI Pharmaceuticals (OSIP) said an independent Data Monitoring Committee (DMC) recommended that front-line therapy of OSIP's Tarceva be discontinued at the time of disease progression or the start of second-line chemotherapy or radiation in the U.S. Phase III TRIBUTE trial for non-small cell lung cancer (NSCLC). The original protocol in the 1,050-patient study allowed for treatment with Tarceva after patients' disease progressed following treatment with the EGFR inhibitor. OSIP said this part of the protocol was "a novel approach in oncology," and is not significantly used in other Tarceva trials. The company also said it does not expect the protocol change to alter top-line data for its front-line trials of Tarceva in combination with chemotherapy for NSCLC. ...