ArQule, Inc announced a Special Protocol Assessment (SPA) agreement with the US Food and Drug Administration (FDA) for the design of a phase-3 trial of ARQ 197 in patients with non-small cell lung cancer (NSCLC) of non-squamous histology.

Daiichi Sankyo Co, Ltd, the holder of the Investigational New Drug application for ARQ 197 and ArQule's partner for the development of the compound, will conduct the phase 3 trial, which is planned for initiation later this year.

The trial will be a randomized, double-blinded study of erlotinib plus ARQ 197 in patients with locally advanced or metatstatic NSCLC of non-squamous histology. The primary endpoint is overall survival in the intent-to-treat population. Key secondary objectives include overall survival in the epidermal growth factor receptor wild-type sub-population and progression-free survival in the intent-to-treat population.

The SPA process is a procedure by which the FDA provides official evaluation and written guidance on the design and size of proposed protocols that are intended to form the basis for a New Drug Application. Final marketing approval depends on the results of the trial.

ARQ 197 is a selective small molecule inhibitor of the c-MET receptor tyrosine kinase, and erlotinib is an inhibitor of epidermal growth factor receptor.

Patients, physicians and other healthcare professionals seeking additional information regarding this trial and other trials involving ARQ 197 may call 1-800-373-7827.

ARQ 197 is an orally available, selective inhibitor of c-MET, a receptor tyrosine kinase. When abnormally activated, c-MET plays multiple roles in aspects of human cancer, including cancer cell growth, survival, angiogenesis, invasion and metastasis.

ArQule is a biotechnology company engaged in the research and development of next-generation, small-molecule cancer therapeutics.