Velcade enters Ph II trial in advanced NSCLC

Millennium Pharmaceuticals of the USA has inititated a three-arm, randomized, Phase II study of Velcade (bortezomib) and pemetrexed in patients with locally-advanced or metastatic non-small cell lung cancer who have failed prior chemotherapy treatment, together with its co-development partner, the R&D division of US health care giant Johnson & Johnson.

The Phase II randomized, open-label, multicenter study will enroll approximately 135 patients and its primary endpoint is objective response rate as assessed by Response Evaluation Criteria in Solid Tumors. Secondary endpoints include disease control rates, time-to-progression, progression-free survival and safety.