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

Sponsor
Fondazione Ricerca Traslazionale
Study ID
NCT07264673
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Tedopi — DRUG
    Cemiplimab + OSE2101 (TEDOPI®) (ARM B: experimental arm)
  • Cemiplimab — DRUG
    Cemiplimab +/-Pemetrexed (ARM A: standard arm)

Study Details

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 Dates

Start date
Apr 17, 2025
Status verified
Nov 2025
Primary completion
Oct 31, 2027
Completion
Oct 31, 2029

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: A
    Cemiplimab 350 mg iv q21 single agent (squamous histology) or Cemiplimab 350 mg iv q21 plus pemetrexed 500mg/m2 q21 (non- squamous histology).
  • Experimental: B
    Cemiplimab 350 mg iv q 21 plus OSE2101 (TEDOPI®). The OSE2101 (TEDOPI®) dose to be injected is of 1 mL (5 mg of drug product) by subcutaneousubcutaneous administration

Primary Outcome Measure

ctDNA clearance rate [ Time Frame: 48 months ]

Central Contacts

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