drugset / Trial / NCT07264673
A Randomized Phase II Trial of Cemiplimab Plus OSE2101 ( TEDOPI®) as Maintenance Therapy in ctDNA Positive NSCL. The Cemited Study.
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a phase II randomized study investigating whether a combination maintenance with Cemiplimab and OSE2101 (TEDOPI®) could increase ctDNA clearance rate versus standard maintenance therapy in HLA-A2 positive NSCLC patients not progressing after 4 cycles of chemo-immunotherapy.
Timeline
- Start
- 2025-04-17
- Primary completion
- 2027-10
- Completion
- 2029-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | OSE2101 | Vaccine | 5 mg | Subcutaneous |
| Comparator | Cemiplimab | Monoclonal antibody | 350 mg | Intravenous |