The trial is in patients with either advanced bronchioloalveolar carcinoma (BAC) or adenocarcinoma with BAC features that have progressed on or after receiving one to two lines of chemotherapy, one of which must have been an epidermal growth factor receptor tyrosine kinase inhibitor (EGRF TKI).
The open-label study will assess efficacy in terms of tumor response rate measured by response evaluation criteria in solid tumors (RECIST) guidelines.
“Millennium, and our partner Johnson and Johnson, are committed to investigating Velcade as a therapy for lung cancer and this trial is an integral component of our global development plan,” said Dr David Schenkein, senior vice president of clinical research at Millennium. “In reviewing previous Velcade experiences, we saw several dramatic single-agent responses in patients with BAC and we are eager to explore the potential of Velcade so that we may be able to offer new options for patients in need.”
Velcade is approved in the US for the treatment of patients who have received at least one prior therapy. It is being investigated globally in phase I, II and III clinical trials in both hematologic and solid tumors.