drugset / Trial / NCT07264673

A Randomized Phase II Trial of Cemiplimab Plus OSE2101 ( TEDOPI®) as Maintenance Therapy in ctDNA Positive NSCL. The Cemited Study.

NCT07264673

Phase 2 Recruiting 160 enrolled Fondazione Ricerca Traslazionale
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

EvaluationDrugModalityDoseRoute
Subject OSE2101 Vaccine 5 mg Subcutaneous
Comparator Cemiplimab Monoclonal antibody 350 mg Intravenous