NCI launches second precision medicine master protocol

The National Clinical Trials Network (NCTN) launched the ALCHEMIST protocol to identify early stage non-small cell lung cancer (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.

Response Genetics Inc. (NASDAQ:RGDX) 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 one of two double-blind, placebo-controlled, U.S. Phase III 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. Both trials will evaluate overall survival (OS) as the primary endpoint and disease-free survival (DFS) as a secondary endpoint. ...