Study Evaluating MAC-321 in Non-small Cell Lung Cancer Refractory to Platinum-based Therapy

A Phase 2, Open-label Study of MAC-321 Administered Intravenously as a Single Agent for the Treatment of Non-small Cell Lung Cancer Refractory to Platinum-based Therapy

This non-randomized, open-label clinical trial is designed to determine safety and clinical activity of a new chemotherapeutic agent, MAC-321, when given intravenously to patients with non-small cell lung cancer. Clinical activity will be evaluated by determining the percentage of patients with an objective tumor response after treatment with MAC-321. Patients must have been previously treated with a platinum-containing chemotherapy regimen. A total of 96 patients will be enrolled in this trial. Eligible patients will receive MAC-321 intravenously every 3 weeks for up to a total of 6 courses of treatment. All patients will receive MAC-321 at the same dose. MAC-321 is an experimental drug, and is not offered outside of this research trial.

Inclusion Criteria: Recurrence of non-small cell lung cancer after at least 1 prior chemotherapy regimen containing a platinum agent Recovery from all acute side effects of prior therapies (with the exception of hair loss) Adequate bone marrow, liver, and kidney function Exclusion Criteria: More than 2 prior chemotherapy regimens for treatment of advanced or metastatic non-small cell lung cancer. (Treatment given in conjunction with surgery will not be included in the maximum of 2 prior regimens) Radiation therapy, chemotherapy or any other anticancer therapy within 28 days of beginning study Symptomatic brain metastases