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

NCT07264673 | Recruiting Phase 2

• 1 other identifier: CEMITED
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

NSCLC

Outcome Measures

Primary Outcomes (1)

• ctDNA clearance rate

  Differences in ctDNA clearance rate in the two arms of treatment Differences in ctDNA clearance rate in the two arms of treatment Differences in ctDNA clearance rate in the two arms of treatment Differences in ctDNA clearance rate in the two arms of treatment

  48 months

Study Arms (2)

A

ACTIVE COMPARATOR

Cemiplimab 350 mg iv q21 single agent (squamous histology) or Cemiplimab 350 mg iv q21 plus pemetrexed 500mg/m2 q21 (non- squamous histology).

Drug: Cemiplimab

B

EXPERIMENTAL

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

Drug: Tedopi

Interventions

Tedopi DRUG

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

Also known as: Cemiplimab

B

Cemiplimab DRUG

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

A

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed diagnosis of non- oncogene addicted advanced, locally advanced (not suitable for definitive chemoradiation therapy) or metastatic non-small-cell lung cancer (NSCLC)
• Any patient candidate for first line chemo-immunotherapy irrespective of PD-L1 levels
• HLA-A2 positive
• ECOG PS 0-1
• Signed informed consent (IC) prior to any trial-specific procedures

You may not qualify if:

• Patients not candidate for chemo-immunotherapy
• HLA-A2 negative
• Symptomatic or not previously treated and not stable brain metastases. Brain metastases are allowed if asymptomatic or pretreated
• Evidence of EGFR mutations or ALK or ROS1 rearrangements
• Performance status \>1 (ECOG)
• Diagnosis of another cancer in the last 3 years, except for in situ carcinoma of cervix, breast and bladder or skin carcinoma(squamous or basaloid)

Sponsors & Collaborators

• Fondazione Ricerca Traslazionale: lead

Study Sites (1)

Istituti Fisioterapici Ospitalieri- Ifo - Istituto Regina Elena

Roma, RM, 00144, Italy

RECRUITING

MeSH Terms

Interventions

cemiplimab

Central Study Contacts

Federico Cappuzzo, Medical Oncology

CONTACT

+390652665789; federico.cappuzzo@fondazionefort.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: phase II randomized study

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 4, 2025
• Study Start: April 17, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2029
• Last Updated: December 4, 2025

Record last verified: 2025-11

Locations

IT (1)