drugset / Trial / NCT02654587

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

NCT02654587

Phase 3 Terminated 219 enrolled OSE Immunotherapeutics
RandomizedParallel-groupOpen-labelTreatment

Summary

The aim of this clinical trial was to determine if the therapeutic cancer vaccine OSE2101 (TEDOPI) was more effective than standard chemotherapy (docetaxel or pemetrexed) in treating HLA-A2 positive patients with metastatic NSCLC who progressed after sequential or concurrent chemotherapy and immune checkpoint inhibitor given in first or second-line treatment. The main questions were to compare the survival, the tolerance to treatment and the quality of life of patients between the two arms of treatment (OSE2101 versus standard chemotherapy)

Timeline

Start
2016-02-12
Primary completion
2021-01-15
Completion
2021-01-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Docetaxel Small molecule 75 mg/m2 Intravenous
Subject OSE2101 Vaccine 5 mg Subcutaneous
Comparator Pemetrexed Small molecule 500 mg/m2 Intravenous