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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