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RECRUITING
NCT07264673
PHASE2
A Randomized Phase II Trial of Cemiplimab Plus OSE2101 ( TEDOPI®) as Maintenance Therapy in ctDNA Positive NSCL. The Cemited Study.
Sponsor: Fondazione Ricerca Traslazionale
View on ClinicalTrials.gov
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.
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2025-04-17
Completion Date
2029-10
Last Updated
2025-12-04
Healthy Volunteers
No
Conditions
Interventions
DRUG
Tedopi
Cemiplimab + OSE2101 (TEDOPI®) (ARM B: experimental arm)
DRUG
Cemiplimab
Cemiplimab +/-Pemetrexed (ARM A: standard arm)
Locations (1)
Istituti Fisioterapici Ospitalieri- Ifo - Istituto Regina Elena
Roma, RM, Italy