Two hundred forty (240) patients will be randomized (2:1:1) to receive: Arm 1: Docetaxel 75 mg/m2 intravenously given every 3 weeks for 4 doses; Arm 2a: Tergenpumatucel-L at 300 million cells given by intradermal injection weekly for 11 weeks then every 2 months for 5 additional doses (up to a total of 16 immunizations); Arm 2b: Tergenpumatucel-L at 300 million cells given by intradermal injection every 2 weeks for 6 doses and then every month for 10 additional doses (up to a total of 16 immunizations).
Phase 3 Study Design
In the phase 3 portion of the study, patients will be randomized (1:1) to receive either docetaxel or tergenpumatucel-L at the dose level that was selected in the Phase 2B portion of the study. At the planned interim analysis a sample size re-estimation will be performed that will determine the final enrollment numbers for the trial.
About Non-Small Cell Lung Cancer
According to the American Cancer Society, lung cancer is the leading cause of cancer-related death in
the United States
. The NCI estimates that over 160,000 Americans will die of the disease in 2012, accounting for approximately 28% of all cancer deaths. It accounts for more deaths than the next four most common cancers combined. Despite improvements in diagnosis and treatment, the overall 5-year survival for all patients with lung cancer is a dismal 13-16%, and this declines to less than 2% in patients with metastatic disease. Lung cancer is most often diagnosed at advanced stages when it is difficult to treat. According to the American Cancer Society, about 85% to 90% of lung cancers are classified as NSCLC. The remainder is called small cell lung cancer. The American Cancer Society also reports that about 80% of NSCLC cases are detected when they have progressed to stages III or IV. The current expected overall survival for a nonresectable stage IIIB or IV NSCLC patient who has failed first line treatment is approximately eight months.
The HyperAcute-Lung Immunotherapy product candidate, tergenpumatucel-L, consists of three separate allogeneic lung tumor cell lines grown in large cultures, harvested, packaged and irradiated. These component cells are representative of the three major types of non-small cell lung cancer and have been engineered to express a foreign gene encoding the alpha-galactosyl transferase enzyme. This enzyme modifies the surface of the cells in tergenpumatucel-L to make them more easily recognized and attacked by the immune system. After vaccination with tergenpumatucel-L, some patients' immune systems respond by recognizing new lung cancer antigens in ways thought to be helpful in fighting their own tumor.