The primary objective of the study is to assess the overall response rate to the combination of bavituximab with a standard regimen of carboplatin and paclitaxel in non-small cell lung cancer (NSCLC) patients. The multi-center clinical trial is being conducted in India.
In the trial’s two-stage design, up to 21 patients with NSCLC will be enrolled initially. The study will then be expanded up to a total of 49 patients if promising results are observed in the initial cohort.
Secondary objectives of the study include time to tumor progression, duration of response, overall patient survival and safety parameters. Tumor response in the study will be evaluated using response evaluation criteria in solid tumors parameters. Patients may continue to receive bavituximab as long as the cancer does not progress and side effects are acceptable.
Steven King, president and CEO of Peregrine, said: “The initiation of patient enrollment and dosing in our trial of bavituximab in combination with chemotherapy in lung cancer patients marks an important milestone in our Phase II bavituximab clinical program.”