Phase II Trial of Velcade/Alimta Initiated in Advanced NSCLC

CAMBRIDGE, Massachusetts—Millennium Pharmaceuticals and Johnson & Johnson have initiated a randomized, phase II open-label study of the potential benefit of combining two targeted therapies with different mechanisms of action—bortezomib (Velcade) and pemetrexed (Alimta, Eli Lilly)—in previously treated patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC). The accrual goal is approximately 135 patients, and the primary endpoint is objective response rate as assessed by RECIST criteria. Participants will be assigned to one of three treatment arms: Velcade in combination with pemetrexed, pemetrexed alone, or Velcade alone.