Introduction ................................................................................................................................................... 6 2. Trial Objectives ............................................................................................................................................... 7 3. Trial Design .................................................................................................................................................... 9 4. Patient Population and endpoints ..................................................................................................................11 4.1 Patient Populations ..............................................................................................................................11 5. Data Conventions and general analysis ..........................................................................................................12 5.1 Patient disposition ...............................................................................................................................12 5.2 Baseline characteristics ........................................................................................................................12 5.3 Patient withdrawal ...............................................................................................................................14 5.4 Protocol deviations ..............................................................................................................................14 5.5 Treatment compliance .........................................................................................................................15 5.6 Safety ...................................................................................................................................................16 5.7 Adverse Events .....................................................................................................................................17 5.8 Laboratory results ................................................................................................................................18 5.8.1 Additional safety tables ................................................................................................................18 5.8.2 Stopping rule criteria ...................................................................................................................19 5.9 Efficacy ................................................................................................................................................19 5.10 General data conventions .....................................................................................................................20 5.11 Decimal places .....................................................................................................................................21 5.12 Statistical software ...............................................................................................................................21 5.13 Supplementary analysis – Pharmacodynamics (data collected outside of the clinical database) .............21 5.13.1 HLA Pre -screening ........................................................................................................................21 5.13.2 Secondary endpoints ...................................................................................................................22 5.13.3 Tertiary endpoints .......................................................................................................................22 5.14 Other statistical analysis .......................................................................................................................25 5.14.1 Stratification and covariate analysis .............................................................................................25 5.14.2 Multivariate analysis ....................................................................................................................25 5.14.3 Subgroup analysis ........................................................................................................................25 5.14.4 Interim analysis ............................................................................................................................25 5.14.5 Final analysis ................................................................................................................................25 6. Tables listings and figures ..............................................................................................................................26 6.1 LISTINGS ..............................................................................................................................................26 6.2 SUMMARY TABLES ...............................................................................................................................27 7. Presentation of Results in Clinicaltrials.gov Including Additional Tables ..........................................................28 7.1 Arms and Interventions ........................................................................................................................28 7.2 Participant Flow ...................................................................................................................................29 SM.TEMP.013 version 5 CRUKD/17/003 RAP Version: 2.0 09Mar2023 FINAL 5 7.3 Baseline Characteristics ........................................................................................................................31 7.4 Reported Adverse Events (clinicaltrials.gov template sections) .............................................................32 7.5 Outcome Measures ..............................................................................................................................34 7.5.1 Outcome Measure 1 – Frequency and causality of AEs and SAEs to AST -VAC2 (Safety Population) 37 7.5.2 Outcome Measure 2 - Number of participants experiencing ISRs by grade (Safety Population) .....38 7.5.3 Outcome Measure 3 – Number of participants showing a durable peripheral immune response (Secondary Immunogenicity Endpoint Population) .........................................................................................39 7.5.4 Outcome Measure 4 – Mean fold change over baseline by timepoint (Secondary Immunogenicity Endpoint Population) .....................................................................................................................................40 7.5.5 Outcome Measure 5 - Tumour response according to Immune -Related Response Criteria (irRC) post vaccination (Response population) .........................................................................................................41 7.5.6 Outcome Measure 6 – Overall survival at 2 years post first vaccination (Safety Population) ..........42 7.6 Statistical Analyses ...............................................................................................................................42 8. Reporting of Clinical trial results to patients and public ..................................................................................43 9. References ....................................................................................................................................................43 SM.TEMP.013 version 5 CRUKD/17/003 RAP Version: 2.0 09Mar2023 FINAL 6 1. INTRODUCTION This document explains in detail the reporting analyses that will be carried out for Phase I trial of AST-VAC2 vaccine in patients with non -small cell lung cancer . The analyses described in this RAP are based upon and supplement those described in the current study protocol.