8.1. Subjec t Disposition A summary of the analysis sets considered in the CSR will include the number and percentage of subjects for the following categories: subjects randomized, subjects in the ITT set s, subjects not treated, subjects in the Safety sets, and subjects having permanently discontinued the study treatment, subjects in the PP sets. All percentages will be based on the number of subjects randomized. A table will present by treatment arm on the ITT set s the primary reason for not being treated and t he primary reason for permanent treatment discontinuation (with sub -counts of patients having entered the follow -up and patients having not entered the follow -up). A table will present by treatment arm on the ITT set s the number and percentage of patients randomized by month. 8.2. Patients Randomized by Month The number and percent of subjects randomized will be summarized by month by treatment arm for the ITT set s. 8.3. Protocol Deviations Protocol deviations on inclusion/exclusion criteria will be summarized by tre atment arm on the ITT sets. Major protocol deviations, as finalized during the blinded review of the data prior to database lock (organized by the Sponsor with the participation of two coordinating investigators and of one independent expert ) may result in the removal of subjects from the PP sets. The Sponsor or designee will be responsible for producing the final major devi ation file; this file will include a description of the protocol deviation leading to the exclusion from the PP sets. This file will be finalized prior to database lock , and all information will be included in the SDTM.DV domain (deviations domain) . A summary table of the major protocol deviations will be generated on the ITT sets. 8.4. Demographics and Baseline Characteristics Subject demographic data and baseline characteristics will be tabulated and summarized descriptively by treatment arm and overall. The demographic data and baseline characteristics OSE Immunotherapeutics v2.2 Study OSE2101C301 (ATALANTE 1) Statistical Analysis Plan 2021 -07-23 IND#: BB-IND 10802 CONFIDENTIAL P a g e | 27/51 will be summarized for the ITT sets. Individual subject demographics and baseline characteristics will be provided in listings. The demographics consist of age, gender, race, ethnicity, smoking status, BMI , BMI classification and country . The country will be derived from the 2 leading digits of the site as follows: Leading digits of site identification Country 11 Czech Republic 12 France 13 Germany 14 Hungary 15 Italy 16 Poland 17 Spain 18 United Kingdom 19 USA 22 Israel The baseline characteristics c onsist of: • Histology (Squamous/Non -Squamous) • Initial (i.e., best) response to 1st line treatment (CR/PR, SD/PD) • Previous treatment with ICI • Line rank of previous treatment with ICI • Previous Pemetrexed treatment • Line rank of study treatment • Previous radiotherapy combined with chemotherapy • Best response during 1st line the rapy • Time from end of previous line of therapy to study treatment initiation (weeks) • Best response during ICI therapy • Time from end of ICI to study treatment initiation (weeks) • Time from end of chemotherapy to study treatment initiation (weeks) • Duration of ICI therapy (weeks: 0 -12, >12 -24, > 24) • Cancer staging at diagnosis (I/II, IIIA/IIIB/IIIC, IVA/IVB) • Cancer staging at study entry (III, IV) • T classification at diagnosis OSE Immunotherapeutics v2.2 Study OSE2101C301 (ATALANTE 1) Statistical Analysis Plan 2021 -07-23 IND#: BB-IND 10802 CONFIDENTIAL P a g e | 28/51 • N classification at diagnosis • M classification at diagnosis • M classificati on at study entry • Location of metastases at diagnosis • Location of metastases at study entry • Number of different metastasis locations • ECOG score at baseline • HLA -A2 (negative, positive) as documented in NSCLC disease history • EGFR (negative, positive) as docu mented in NSCLC disease history • PD-L1 (negative, positive) as coded in the Data Management manually derived variable DIS_HIST.PDL1_POSNEG _D • Albumin Classification at baseline (< 35 g/L/>= 35 g/L) • LDH Classification at baseline ( <= upper limit of normal range ( ULN ), > ULN ) • dNLR at baseline (< 3 vs ≥ 3 ) • Antibiotic treatment within 30 days before randomization • Corticosteroid treatment within 30 days before randomization For the baseline characteristics, the baseline is defined as the last value avail able up to the date of randomization included. Previous medications for NSCLC were reviewed before database lock and identified as ICI, chemotherapy other than pemetrexed, pemetrexed, other. To get the drug name of the ICI treatment, a manually prepared Excel file (‘210415 Previous ICI description.xlsx ') will also be used. This Excel file provides for each patient the name (variable ICI_DCI) and the class (variable Class) of the ICI treatment and a technical variable (ICI_DCI_link) allowing to match the other ICI information recorded in PRIOTHER. The li ne rank of ICI therapy was manually derived by Data Management after medical and clinical review of each patient prior medications. The category '3rd line therapy' , recorded for one patient, will be displayed in the description of baseline characteristics but pooled with the category '2nd line therapy' in the overall survival subgroup analyses. To derive Best response during ICI therapy, Time since end of ICI therapy, Duration of ICI therapy, additional information about the ICI (best response, start date, end date) will be recovered by respectively retaining the best "best response" across records, the earliest start date across records, and the latest end date across records. An additional table will be provided presenting per arm and overall, the two vari ables Best response during ICI therapy crossed with duration of ICI therapy (weeks: 0 -12, >12 -24, > 24). The dataset DIS_HIST was collecting cancer stage according to TNM V7.0 until June 2017, i.e., during the first part of the study. The study restarted i n June 2018. In the meantime, protocol 5.0 dated 15 March 2018 had introduced the use of TNM V8.0. Therefore, the dataset DIS_HIST collected cancer stage according to TNM V8.0 for all patients of the second part of the study. Therefore , cancer stage was re viewed and sometimes updated by clinical expert OSE Immunotherapeutics v2.2 Study OSE2101C301 (ATALANTE 1) Statistical Analysis Plan 2021 -07-23 IND#: BB-IND 10802 CONFIDENTIAL P a g e | 29/51 before database lock. Reclassified cancer staging value will be analyzed, categorized as follows: • Cancer stage at diagnosis: (I/II) mapped to 'I/II', (IIIA, IIIB, IIIC) mapped to 'IIIA/IIIB/IIIC ', (IV, IVA, I VB) mapped to 'IVA/IVB ' • Cancer stage at study entry: (IIIB, IIIC) mapped to 'III', (IV, IVA, IVB) mapped to 'IV', (IIIA, Other) mapped to 'Other '. The category 'Other' will be displayed in the description of baseline characteristics but not retained in the overall survival subgroup analyses. Liver, Bone, and Brain will be counted as a metastasis location if the number of metastases reported is in (1, 2, 3, >3, NS). Other will be counted as a metastasis location if the number of metastases reported is in (1, 2, 3, >3, NS) for at least one of the 'Other' locations. Adrenal will be counted as a metastasis location if reported as ('Unilateral','Bilateral',NS). Pleura will be counted as a metastasi s location if reported as 'Present'. 'Number of different metastasis locations' must be understood as 'Number of different metastasis locations' at study entry'. This number is left missing if the M classification at study entry is missing. Protocol secti on 4.3.3 requires that patients of arm B take dexamethasone (a corticosteroid) twice daily before, the day of and the day after study drug (docetaxel or pemetrexed). Therefore, comparing the 2 treatment arms on presence/absence of corticosteroids on the da y before randomization or on the day of randomization is biased. 'Corticosteroid treatment within 30 days before randomization' is changed to 'Corticosteroid treatment within 2 to 30 days before randomization'. The Data Management manually derived variable s WHODRUG.ANTIBIO_D and WHODRUG.CORTI_D identify systemic antibiotic treatments and corticosteroid treatments without selection on their administration dates. Start and end dates of these treatments will be checked versus the randomization date to identify antibiotic treatment within 30 days before randomization and corticosteroid treatment within 2 to 30 days before randomization. 8.5. Previous ICI Treatment The number and percentages of patients by previous ICI treatment will be summarized on the ITT set s by treatment arm, Anatomical Therapeutic Chemical (ATC) level 4 (sorted according to the corresponding 5 -digit ATC code), and PT . The previous ICI treatment information will be taken from information entered (not necessarily in a consistent way with the actual ICI line rank) for 1st line therapy, 2nd line therapy or 3rd line therapy in prior medications for NSCLC based on the Data Management manually derived variable PRIOTHER. LINE_ICI_D . A listing describing for the most used ICI treatments as nivolumab, pembro lizumab , atezolizumab , avelumab , durvalumab with a complete description will be provided (dose, treatment duration, response, …). OSE Immunotherapeutics v2.2 Study OSE2101C301 (ATALANTE 1) Statistical Analysis Plan 2021 -07-23 IND#: BB-IND 10802 CONFIDENTIAL P a g e | 30/51 The description of the previous ICI treatment by class will be prepared from the Excel file ('200720 Previous ICI description.xlsx') as described in section 8.4 under 'Addition or change after 04 June 2020'. 8.6. History of Immune -Related Adverse Events The number and percent of subjects with a history of irAEs will be summarized by irAE category and preferred term by trea tment arm for the ITT sets. The same presentation will be used to summarize the irAEs ongoing at screening. 8.7. Randomization Stratification Factors Randomization stratification factors will be tabulated and summarized descriptively by treatment arm and overal l, for the ITT sets. The following strata will be summarized: • Squamous/Non -squamous • Objective response/No objective response • First line therapy/Second line therapy. The values reported for the stratification factors will be those possibly corrected by the site after time of randomization and therefore may be different of the values used for the randomization. For analyses, corrected from eCRF (and not IWRS) values will be used. For the 38 ICI patients randomized before the amendment ( i.e., at a time where the stratification factor First line therapy/Second line therapy was not yet applicable), the Data Management manually derived IC.RANDIMM2_1_D will be used in place of IC.RANDIMM2_1 (the data field IC.RANDIMM2_1was not existing in the database at the time the "Old" ICI were randomized). Randomization stratification factors as entered in the IVRS/IWRS at time of randomization will also be tabulated and summarized descriptively by treatment arm and overall, for the ITT set, separately for patients randomized before the amendment and patients after the amendment. Within each subset of patients (randomized before/after amendment), t he randomization stratification factors as entered in the IVRS/IWRS for each randomized patient will be derived from the leading dig it of the corresponding randomization number. For patients randomized before the amendment the correspondence is as follows: OSE Immunotherapeutics v2.2 Study OSE2101C301 (ATALANTE 1) Statistical Analysis Plan 2021 -07-23 IND#: BB-IND 10802 CONFIDENTIAL P a g e | 31/51 Leading digit Histology Initial response to 1st line treatment Previous treatment with ICI 1 Squamous Objective response Previous ICI 2 Squamous Objective response No previous ICI 3 Squamous No objective response Previous ICI 4 Squamous No objective response No previous ICI 5 Non-Squamous Objective response Previous ICI 6 Non-Squamous Objective response No previous ICI 7 Non-Squamous No objective response Previous ICI 8 Non-Squamous No objective response No previous ICI For patients randomized before the amendment the correspondence is as follows: Leading digit randhist_1r randrsp_1r randimm2_1r 1 Squamous Objective response 1st line ICI 2 Squamous Objective response 2nd line ICI 3 Squamous No objective response 1st line ICI 4 Squamous No objective response 2nd line ICI 5 Non-Squamous Objective response 1st line ICI 6 Non-Squamous Objective response 2nd line ICI 7 Non-Squamous No objective response 1st line ICI 8 Non-Squamous No objective response 2nd line ICI A patient listing will display the patients with stratification factors discrepancies between the values entered in the IVRS/IWRS and values corrected by the site after time of randomization. The second table in this section applies to patients randomized after the amendment (not before). In this table ‘randhist_1r’, randrsp_1r, and randimm2_1r respectively correspond to Histology, Initial response to 1st line treatment, and line rank of ICI therapy. 8.8. Medical History The number and percent of subjects with i ndividual concurrent illness and medical histories will be summarized by treatment arm . Individual subject listings will also be provided for concurrent illness and medical history. OSE Immunotherapeutics v2.2 Study OSE2101C301 (ATALANTE 1) Statistical Analysis Plan 2021 -07-23 IND#: BB-IND 10802 CONFIDENTIAL P a g e | 32/51 Medical history will be coded using MedDRA Version 20.1. The number and percentage of subjects with any medical history will be summarized overall and for each system organ class (SOC) and preferred term (PT). Percentages will be calculated based on number of subjects in the ITT sets. Subject medical history dat a including specific details will be presented in a listing.