OSE2101 Versus Chemotherapy in HLA-A2 Positive Patients With Advanced NSCLC After Immune Checkpoint Inhibitor Failure

Inclusion Criteria

• •1. Signed and dated informed consent
• •2. Willingness and ability to comply with the clinical study procedures.
• •3. Female or male, 18 years of age or older
• •4. Histologically or cytologically proven diagnosis of Non-Small Cell Lung Cancer (NSCLC) that is locally advanced (stage III) unsuitable for radiotherapy or metastatic (stage IV) according to the 8th edition of tumor, node, metastasis (TNM) in Lung Cancer
• •5. Subjects with disease recurrence or progression after immune checkpoint inhibitor and platinum-based chemotherapy:
• •i) either 1st line chemotherapy followed by 2nd line immune checkpoint inhibitor, or ii) 1st line combination of immune checkpoint inhibitor and chemotherapy Patients with progression during or within 12 months after the end of immune checkpoint inhibitor given as sequential or concomitant platinum-based chemotherapy ± radiation for locally advanced disease (stage III) were eligible
• •6. Subjects with measurable or non-measurable lesions according to RECIST 1.1
• •7. Subjects must express HLA-A2 phenotype (central test in blood)
• •8. Subjects must be considered suitable for chemotherapy with single-agent pemetrexed or single-agent docetaxel
• •10. Any prior chemotherapy, immunotherapy, hormonal therapy, radiation therapy or surgeries must have been completed at least 3 weeks prior to initiation of study treatment.
• •11. Any toxicity from prior therapy must have recovered to ≤ Grade 1 (except alopecia)
• •12. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• •13. Adequate organ function as defined by all the following criteria:
• •* Albuminemia \> 25g/L
• •* Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 1.5 x upper limit of normal (ULN) with alkaline phosphatase ≤ 2.5 x ULN, or AST and ALT ≤ 5 x ULN if liver function abnormalities are due to liver metastases
• •* Total serum bilirubin ≤ 1.5 x ULN
• •* Absolute neutrophil count (ANC) ≥ 1500/L
• •* Platelets ≥ 100000/L
• •* Hemoglobin ≥ 9.0 g/dL (in the absence of transfusion within 2 weeks before randomization)
• •* Creatinine clearance (based on modified Cockcroft-Gault formula) ≥ 45 ml/min.
• •15. Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study
• •16. Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment
• •17. Male patients sexually active with a woman of childbearing potential must be surgically sterile or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. The decision of effective contraception will be based on the judgment of the principal investigator
• •18. Breastfeeding women
• •19. Women with a positive pregnancy test.