NCT07264673 A Randomized Phase II Trial of Cemiplimab Plus OSE2101 ( TEDOPI®) as Maintenance Therapy in ctDNA Positive NSCL. The Cemited Study.
| NCT ID | NCT07264673 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fondazione Ricerca Traslazionale |
| Condition | NSCLC |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2025-04-17 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 160 participants in total. It began in 2025-04-17 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Tumor tissue not available (archive or collected before trial inclusion) * 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07264673 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying NSCLC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07264673 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07264673 currently recruiting?
Yes, NCT07264673 is actively recruiting participants. Contact the research team at federico.cappuzzo@fondazionefort.org for enrollment information.
Where is the NCT07264673 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT07264673 clinical trial?
NCT07264673 is sponsored by Fondazione Ricerca Traslazionale. The trial plans to enroll 160 participants.