Treatment for advanced stage non-small cell lung cancer is limited. In an attempt to determine whether immune stimulating activity can be induced with a GMCSF gene transduced autologous tumor vaccine (GVAX), 83 patients were entered into trial (20 with stage 1B/IIB disease and 63 with stage IIIB/IV disease). Patients fulfilling eligibility criteria underwent surgical harvest of autologous lung tumor tissue. The tissue was then processed, transfected with an E1 deleted, E3 deleted adenoviral GMCSF gene vector irradiated prior to injection. Patients received a series of six vaccinations (1 every two weeks). Forty-three of the 83 patients were eligible for treatment (10 in cohort A and 33 in cohort B). These results have previously been reported. GVAX was well tolerated. Three of 33 patients with advanced disease achieved complete response. Evidence of immunologic activity following vaccination in a subset of patients was suggested, based on antibody response to either autologous SV40 transformed tumor cells or allogeneic non-small cell lung cancer tumor cells. These results supported further clinical investigation with GVAX in non-small cell lung cancer.