................................ ..65 OSE2101 Protocol OSE2101C301 Confidential Version n°6.0 Page 23 of 101 02 February 2022 LIST OF ABBREVIATIONS AE Adverse Event ALK Anaplastic Lymphoma Kinase ALT Alanine aminotransferase ANC Absolute neutrophil count AST Aspartate aminotransferase ATC Anatomic Therapeutic Chemical Classification BP Blood Pressure Bpm beats per minute CBC Complete blood count CEA Carcinoembryonic Antigen CFR Code of Federal Regulations CI Confidence interval CR Complete response CRF Case Report Form CRS Cytokine Release Syndrome CT Chemotherapy CTCAE Common Terminology Criteria for Adverse Events CTL Cytotoxic T -lymphocyte CYP3A4 Cytochrome P450, family 3, subfamily A, polypeptide 4 DCR Disease control rate DNA Desoxyribonucleic Acid DoR Duration of response EC Ethics Committee ECG Electrocardiogram ECOG Eastern Cooperative Oncology Group EGFR Epidermal Growth Factor Receptor ELISA Enzyme Linked Immunosorbent Assay ELISPOT Enzyme -Linked Immuno Spot EORTC QLQ European Organization for Research and Treatment of Cancer Quality of Life Questionnaire EOS End of Study EOT End of Treatment FDA Food and Drug Administration FDG -PET Fluorodeoxyglucose Positon Emission Tomography FFPE Formaldehyde Fixed -Paraffin Embedded FISH Fluorescence in situ hybridization G-CSF Granulocyte Colony Stimulating Factor GCP Good Clinical Practice HBV Hepatitis B Virus HCV Hepatitis C Virus HER -2/neu Human Epidermal Receptor -2/neurological OSE2101 Protocol OSE2101C301 Confidential Version n°6.0 Page 24 of 101 02 February 2022 HIV Human Immunodeficiency Virus HLA Human Leukocyte Antigen HR Hazard Ratio HRQoL Health Related Quality of Life HTL Helper T-lymphocyte ICH International Conference on Harmonization ICI Immune Checkpoint Inhibitor IDMC Independent Data Monitoring Committee IFN Interferon IND Investigational New Drug INR International Normalized Ratio irAE Immune -related Adverse Event IRB Institutional Review Board ITT Intent to treat IUD intrauterine device IV Intravenous or intravenously IVD In Vitro Diagnostics Device IVRS/IWRS Interactive voice/web response system LDH Lactate Dehydrogenase LLT Low level terms MAGE 2/3 Melanoma Antigens 2/3 MedDRA Medical Dictionary for Regulatory Activities MRI Magnetic Resonance Imaging NE Not evaluable NSCLC Non Small Cell Lung Cancer ORR Objective response rate OS Overall survival p53 A nuclear –regulatory protein PADRE Pan-DR-Epitope PBMCs Peripheral -blood mononuclear cells PCSA Potential clinically significant abnormality PD Pharmacodynamics PD Progressive disease PET Positon Emission Tomography PFS Progression free survival PR Partial response PR Pulse Rate PRO Patient reported outcomes PT Preferred Term QLQ -C30 and QLQ -LC13 Lung cancer module in EORTC QLQ QoL Quality of life RANK -L Receptor Activator of Nuclear Factor Kappa B ligand OSE2101 Protocol OSE2101C301 Confidential Version n°6.0 Page 25 of 101 02 February 2022 RECIST Response Evaluation Criteria in Solid Tumors rIL Recombinant Interleukin RNA Ribonucleic Acid ROS1 c-ros oncogene 1, receptor tyrosine kinase SAE Serious Adverse Event SAP Statistical analysis plan SD Standard Deviation SD Stable disease SE Standard Error SOC System Organ Class TAA Tumor -associated antigen TKI Tyrosine -Kinase Inhibitor TSH Thyroid Stimulation Hormone TTD Time to deterioration ULN Upper limit of normal WES Whole -Exome sequencing WHO World Health Organization WOCBP Women of childbearing potential WT Wild type OSE2101 Protocol OSE2101C301 Confidential Version n°6.0 Page 26 of 101 02 February 2022 1 BACKGROUND AND RATIONALE 1.1 Target indication Worldwide, lung cancer has the highest incidence (2.09 million) and mortality (1.76 million) among all cancers (Globocan 2018 ; 30). It is the leading cause of cancer death among males in both more and less developed countries, and has surpassed breast cancer as the leading cause of cancer death among females in more developed countries ( 30).