For full details of the trial design, background and rationale for the study, please refer to the current study protocol. SM.TEMP.013 version 5 CRUKD/17/003 RAP Version: 2.0 09Mar2023 FINAL 11 4. PATIENT POPULATION AND ENDPOINTS Patients must fulfil all the inclusion/exclusion criteria to be eligible for entry to the trial. Refer to the study protocol for the complete list of inclusion and exclusion criteria. 4.1 Patient Populations The analysis sets are defined as follows: Full Analysis Population (FAP): All patients who enrolled onto the main trial. Patients who are enrolled in error onto the main trial (due to ineligibility/administrative error), prior to receiving any AST -VAC2 vaccinations , will be excluded from the FAP. Safety Population: All enrolled patients who received at least one AST -VAC2 vaccination . This population will also be used for overall survival at 2 years post first AST -VAC2 vaccination. Patients are evaluable for survival regardless of whether they go on to receive another anti -cancer therapy. HLA Population: All patients who had a sample t aken for HLA analysis. Secondary Immunogenicity Endpoint Population: All eligible patients who received at least three AST-VAC2 vaccinations and have had a baseline blood sample and at least two post -vaccination blood sample s taken . Response Population: All eligible patients who have received at least one AST -VAC2 vaccination and have had a baseline assessment of disease and at least one repeat disease assessment measured according to irRC. For details of irRC, refer to Appendix 3 of the study protocol. If rapid tumour progression occurs before completion of the scheduled six AST -VAC2 vaccinations, the patient will be classified as having early progression. Patients with early progression will be included in the response population. SM.TEMP.013 version 5 CRUKD/17/003 RAP Version: 2.0 09Mar2023 FINAL 12 5. DATA CONVENTIONS AND GENERAL ANALYSIS 5.1 Patient disposition Patients excluded from any population (defined in Section 4.1) will be detaile d. The accrual and trial discontinuation details will be presented descriptively. This should include details of: • Screening failure patients o Pre-screening – patients were pre -screened for human leucocyte antigen ( HLA) status as part of the study. The number of patients who underwent HLA screening and the number of patients HLA A*02:01 positive and negative will be summarised . o Overall screening failure information is available via the e-screening logs and will be described descriptively . • Information on ineligible patients who were enrolled and/or received AST -VAC2 . • Reasons for vaccination discontinuation by number of vaccinations received will be described by counts and percentages. Reasons for vaccination discontinuation other than disease progression will be detailed and summarised separately (Section 5.3). 5.2 Baseline characteristics Demographics and baseline characteristics will be summarised for all enrolled patients. Table 2: Summary of Patient Demography (Full Analysis Population) All Patients N=X Patients Sex Male N (%) Female Age (Years) Mean Median Min Max WHO performance status 0 N (%) 1 2 3 4 *Footnote: withdrew from the study prior to first v accination SM.TEMP.013 version 5 CRUKD/17/003 RAP Version: 2.0 09Mar2023 FINAL 13 In case of pre -treatment characteristics with multiple measurements per patient before the start of treatment (laboratory assessments, vital signs), the baseline measurement will be considered the last value prior to or on the first day of vaccination . Baseline performance status assessments will be summarised with frequency counts. For the cancer history, histologic diagnosis, number of baseline lesions, and involvement in the different sites will be summarised. If incomplete dates are recorded, the rules descri bed in Section 5.10 will be used for imputation. The primary tumour sites and baseline lesions will be recorded in order to categorise them accurately in the analysis. A frequency tabulation of the different types of previous oncologic surgery (excluding only diagnostic or palliative procedures), radiotherapy, or anti -cancer systemic therapy will be given. Table 3: Primary Diagnosis at Baseline (Full Analysis Population) No. of Patients (N=XX) Primary tumour type N (%) Stage at study entry Stage I Stage II Stage III Stage IV Not applicable Not known Table 3 will be manually generated for the Clinical Study Report (CSR) based on the programmed table from the clinical trial database to allow for better grouping by primary tumour type. Table 4: Summary of Prior Treatment for M alignant Disease (Full Analysis Population) No. of Patients (N=XX) Prior treatment Surgery N (%) Radiotherapy Chemotherapy/other SM.TEMP.013 version 5 CRUKD/17/003 RAP Version: 2.0 09Mar2023 FINAL 14 Table 5: Summary of Prior L ines of C hemotherapy/ Other Therapy (Full Analysis Population) No. of Patients (N=XX) Lines of chemotherapy/other 1 N (%) 2 3 4 5, etc Median (range) X (X-X) Table 5 will be manually generated for the Clinical Study Report based on the ‘Previous Treatment for Malignant Disease – Chemotherapy/Other Therapy’ listing . Table 6: Summary of B aseline Disease Sites (Full Analysis Population) Baseline disease type No. of Patients (N=XX) Patient Numbers Primary tumour N (%) XX/XXX, XX/XXX Local recurrence Regional nodes Metastatic nodes Lung metastases Liver metastases Etc 5.3 Patient withdrawal Reasons for patient withdrawal from vaccination will be provided as the data are available and will be presented descriptively . 5.4 Protocol deviations A protocol deviation is defined as any departure from what is described in the protocol of a clinical trial approved by an Independent Ethics Committee and Competent Authorities.