Up to 60 subjects will be enrolled in this study. Eligible subjects will receive 2 prime
vaccinations of CRS-207 (1×10^9 colony-forming units [CFU] given intravenously [i.v.] over 2
hours) (with or without cyclophosphamide) 2 weeks apart followed 2 weeks later by up to 6
cycles of pemetrexed and cisplatin 21 days apart. Three weeks after completion of
chemotherapy, subjects will receive an additional 2 infusions (boost vaccinations) of
CRS-207 3 weeks apart. Subjects will be followed every 8 weeks until disease progression by
immune-related response criteria. Subjects who continue to meet dosing eligibility may
receive additional CRS-207 (with or without cyclophosphamide) infusions (maintenance
vaccinations) at each follow-up visit.
Study assessments include blood draws for safety and immune response monitoring and CT scans
[with optional fluorodeoxyglucose positron emission tomography (FDG-PET)] or magnetic
resonance imaging (MRI) to monitor disease status. In addition, optional tumor biopsies may
be performed before, during and after treatment.