drugset / Trial / NCT02654587
OSE2101 Versus Chemotherapy in HLA-A2 Positive Patients With Advanced NSCLC After Immune Checkpoint Inhibitor Failure
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Subject | OSE2101 | Vaccine | 5 mg | Subcutaneous |
| Comparator | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |