All statistical analyses will be performed and data appendices will be created by using SAS. The effects of noncompliance, dropouts, and covariates will be assessed to determine the impact on the general applicability of results from this study. Unless specified otherwise, summaries will be reported by treatment regimen (Cohort) and overall. This corresponds to Cohort 1 (CRS -207 without Cy), Cohort 2 (CRS -207 with Cy), and overall. For select summaries of disposition, baseline data, and key efficacy endpoints, summaries of Cohort 1 will be further broken out by subjects enrolled in the original and expansion phase . No formal comparisons across enrollment phase (original vs. expansion) or treatment regimen (Cohort 1 vs. Cohort 2) will be performed. Further details of the analysis, including the handling of missing data transformations, assessing impact of the expansion cohort , impact of changes to the planned chemotherapy regimen and further modifications to populations of analysis will be provided i n a separate statistical analysis plan. 8.2.2 Populations of Interest The full analysis (FAS) population is all subjects enrolled who receive at least one dose of study treatment . The per protocol population is defined as subjects who receive two doses of CRS - 207 (with or without Cy) followed by at least 4 cycles of pemetrexed and cisplatin . Subjects with major protocol violations will be excluded from the per protocol population. The precise reasons for excluding subjects from the per protocol set will be fully defined and documented before database lock. 8.2.3 Baseline Comparability Demographics and baseline clinical variables for subjects will be summarized using descriptive statistics . Relationship to efficacy and safety endpoints may be Aduro Biotech , Inc. Protocol ADU -CL-02-v8 CRS -207 with Pemetrexed and Cisplatin Version 8, 08 March 2018 Page 64 assessed via scatter plots for pairs of continuous endpoints and summary statistics within categories for categorical / continuous pairs, and contingency tables (N, percent) for pairs of categorical endpoints. Differences in baseline variables across enrollment phase ( original vs.