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ARTICLE | Clinical News

Tarceva erlotinib: Phase III started

September 1, 2014 7:00 AM UTC

The National Clinical Trials Network (NCTN) launched the ALCHEMIST protocol to identify early stage NSCLC patients with tumors that harbor genetic mutations to understand how early intervention can improve survival outcomes for patients who have undergone complete surgical resection of tumors. The ALCHEMIST protocol comprises 3 component trials -- a screening trial (A151216) and the double-blind, placebo-controlled, U.S. Phase III AO81105 and E4512 trials.

In A151216, Response Genetics Inc. (NASDAQ:RGDX, Los Angeles, Calif.) will screen surgically removed tissue from 8,000 patients to identify those whose tumors harbor EGFR or anaplastic lymphoma kinase (ALK) mutations for enrollment in 1 of the AO81105 and E4512 trials. The Phase III AO81105 trial will enroll 450 EGFR-positive patients to receive standard therapy plus Tarceva erlotinib or standard therapy alone. The Phase III E4512 trial will enroll 378 ALK-positive patients to receive standard therapy plus Xalkori crizotinib or standard therapy alone. ...