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

NCT07264673 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-12-04

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Tedopi

Cemiplimab + OSE2101 (TEDOPI®) (ARM B: experimental arm)

DRUG

Cemiplimab

Cemiplimab +/-Pemetrexed (ARM A: standard arm)

Sponsors & Collaborators

  • Fondazione Ricerca Traslazionale

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-17
Primary Completion
2027-10-31
Completion
2029-10-31

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07264673 on ClinicalTrials.gov