A CLINICAL TRIAL TO STUDY THE EFFICACY AND SAFETY OF PT 107 (VACCINE) IN ADVANCED NON-SMALL CELL LUNG CANCER PATIENTS

INTERVENTION: Intervention1: Allogeneic B7.1/HLA‐A1 Transfected NSCLC Tumor Cell Vaccine: 0.5ml of Vaccine administered through intradermal injection. Will be given total 9 vaccinations once in every 14 days Control Intervention1: Placebo (composed of sterile saline containing 0.5% human serum albumin and 10% DMSO without cells): 0.5ml placebo administered through intradermal injection. Will be given total 9 vaccinations once in every 14 days CONDITION: Advanced non‐small cell lung cancer (Stages IIIB/IV) who have failed first line of chemotherapy PRIMARY OUTCOME: Determine whether patients with advanced or metastatic non‐small cell lung cancer (stages IIIB/IV) who have failed previous platinum‐based chemotherapy (with or without radiation) have an increase in overall survival as a result of vaccination with PT 107.‐‐‐‐‐‐Timepoint: From the date of randomization to the recorded date of death SECONDARY OUTCOME: 1. Safety profile of the PT 107. 2. Time to disease progression in patients immunized with PT 107 vaccine as compared to placebo.‐‐‐‐‐‐Timepoint: 1. Monitored for safety throughout the study. 2. 1st assessment at 13th week and follow‐up assessment on 18th week INCLUSION CRITERIA: 1. Patients with documented stage IIIB or IV advanced or metastatic NSCLC who have completed 4‐6 cycles of platinum based chemotherapy, with or without radiation, and have either stable disease or have experienced disease progression (additional prior adjuvant chemotherapy is permitted). 2. ECOG performance status 0‐2. 3. Presence of at least one measurable lesion according to RECIST criteria. 4. Renal Requirements: The calculated creatinine clearance must be at least 50 ml/min. 5. Pulmonary Function Requirements All patients will undergo evaluation of pulmonary function prior to enrollment. Patients should have a FeV1 more than 30% of the predicted value and/or DLCO more than 30% of the predicted value with a PCO2 < 45mm. Any patient enrolled in the protocol whose respiratory symptoms have experienced marked deterioration not related to a known cause (e.g. pneumonia, CHF or PE) will have request PFT evaluation and if the above para