Study Objectives 4.1.1. Primary Objective (s) The primary objective of the discontinued step-2 is to demonstrate th at in the population of interest ( patients with secondary resistance to ICI), OSE2101 is superior to control treatment with respect to OS in HLA -A2 positive patients with advanced NSCLC after failure to platin - based chemotherapy and ICIs . 4.1.2. Secondary Objectives The secondary objectives of the discontinued step -2 are as follows: • To compare secondary measures of clinical benefit including Post progression Survival, Time to worsening of ECOG, QLQ -C30 Global health status score change from baseli ne, QLQ -C30 Func tional score s change from baseline, QLQ -C30 Symptom score s change from baseline, QLQ -LC13 Symptom score s change from baseline , DCR at 6 months, DCR at 12 months , and Progression -Free Survival (PFS) in the PoI • To assess the safety and tolerability of OSE2101 compared to the control treatment in PoI. Exploratory objectives are to compare other criteria : ORR , Duration of Response, and time to next lung cancer therapy in both treatment arms in PoI. Safety , tolerability, and efficacy incl uding OS will also be done in ITT overall population as exploratory . 4.2. Efficacy Endpoints in step-2 4.2.1. Primary Efficacy Endpoint • Overall survival (OS) 4.2.2. Secondary E fficacy Endpoints • Post Progression Survival • Time to worsening of ECOG • QLQ -C30 Global health status score change from baseline • QLQ -C30 Functional score s change from baseline • QLQ -C30 Symptom score s change from baseline • QLQ -LC13 Symptom score s change from base line OSE Immunotherapeutics v2.2 Study OSE2101C301 (ATALANTE 1) Statistical Analysis Plan 2021 -07-23 IND#: BB-IND 10802 CONFIDENTIAL P a g e | 13/51 • Disease Control Rate (DCR) at 6 months and 12 months • Progression -Free Survival (PFS) Once the primary objective will be established (null hypothesis rejected at 5% two-sided significance level), each of the secondary efficacy endpoints will be tested at 5% significance level using a further hierarchical order in the or dering sequence of the list described above to control the overall type I error. If the primary objective is not established, these endpoints will still be analyzed but interpreted as exploratory endpoints, similarly if one secondary endpoint in the sequen ce is not significant, the lower rank secondary endpoint(s) will be considered exploratory. 4.2.3. Exploratory Efficacy Endpoints • Time to next lung cancer therapy • Objective Response Rate (ORR) • Duration of response (DR) • All the other scores of the quality of life questionnaires 4.2.4. Summary of the primary and secondary endpoints The list of primary and secondary endpoints can be summarized as follows: Population Efficacy endpoint Status PoI-ITT OS P PoI-PP OS S01 PoI-ITT Post progression Survival S02 PoI-ITT Time to worsening of ECOG S03 PoI-ITT QLQ -C30 Global health status change from baseline S04 PoI-ITT QLQ -C30 Functional total score s change from baseline (Physical, Role, Emotional, Cognitive, and Social) S05 PoI-ITT QLQ -C30 Symptom score s change from baseline (Fatigue, Nausea & Vomiting, Pain, Dyspnea, Insomnia, Appetite Loss, Constipation, Diarrhea, and Financial Difficulties) S06 PoI-ITT QLQ -LC13 Symptom score s change from baseline change from baseline S07 PoI-ITT DCR at 6 months S08 PoI-ITT DCR at 12 months S09 PoI-ITT Progression Free Survival S10 OSE Immunotherapeutics v2.2 Study OSE2101C301 (ATALANTE 1) Statistical Analysis Plan 2021 -07-23 IND#: BB-IND 10802 CONFIDENTIAL P a g e | 14/51 P: primary, S: secondary , PoI: Population of Interest 4.3. Safety and Tolerability Endpoints • The incidence, severity, seriousness, and relationship to study treatment of adverse events (AEs) and immune -related adverse events (irAEs) • The abnormalities in safety laboratory parameters • The abnormalities in vital signs • The abnormalities in 12 -lead ECGs 5. STUDY METHODS 5.1.