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 CancerAccording 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. About tergenpumatucel-L 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.
Select the service that is right for you!COMPARE ALL SERVICES
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV