Cemiplimab plus TEDOPI maintenance for ctDNA‑positive HLA‑A2 advanced NSCLC
Official title: A Randomized Phase II Trial of Cemiplimab Plus OSE2101 ( TEDOPI®) as Maintenance Therapy in ctDNA Positive NSCL. The Cemited Study.
Run by Fondazione Ricerca Traslazionale · NCT07264673 · Data updated 2026-11-12
This trial will test whether adding the TEDOPI vaccine to cemiplimab as maintenance can clear circulating tumor DNA in HLA‑A2 positive advanced NSCLC patients who did not progress after four cycles of chemo‑immunotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 160 (estimated) |
| Sponsor | Fondazione Ricerca Traslazionale Academic / other |
| Drugs / interventions | immunotherapy, Cemiplimab, chemotherapy |
| Locations | 1 site (Roma, RM) |
| Status | Recruiting |
| Started | April 17, 2025 |
| Main results expected | October 2027 |
| Study ends | October 2029 |
| Registry record updated | December 4, 2025 |
| Trial ID | NCT07264673 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with advanced or locally advanced non‑oncogene addicted NSCLC who are HLA‑A2 positive, ECOG 0–1, candidates for first‑line chemo‑immunotherapy, and who are not progressing after four cycles of treatment.
✕Probably not a fit
Patients who are HLA‑A2 negative, have oncogenic drivers (EGFR, ALK, ROS1), ECOG >1, or have untreated symptomatic brain metastases are not eligible and would not benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Patients with advanced or locally advanced non‑oncogene addicted NSCLC are screened for HLA‑A2 and receive up to four cycles of investigator‑selected platinum‑based chemotherapy plus cemiplimab. Those without progression after four cycles are tested for ctDNA, and ctDNA‑positive patients are randomized to standard maintenance or cemiplimab combined with OSE2101 (TEDOPI). ctDNA is monitored at baseline (before randomization), before cycle 3 of maintenance, and at progression or end of maintenance to measure clearance rates. The trial focuses on HLA‑A2 positive individuals and includes all histologies and PD‑L1 levels.
Why it matters
Potential benefit: If successful, the combination could increase ctDNA clearance and potentially delay disease progression for HLA‑A2 positive NSCLC patients.
How similar studies have gone: Combining PD‑1 inhibitors with therapeutic cancer vaccines has produced encouraging immune responses in early trials but limited definitive clinical benefit to date, and TEDOPI remains an experimental vaccine in this setting.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
-
Istituti Fisioterapici Ospitalieri- Ifo - Istituto Regina Elena
Roma, Rm, Italy Recruiting
Study contacts
- Study coordinator: Federico Cappuzzo, Medical Oncology
- Email: federico.cappuzzo@fondazionefort.org
- Phone: +390652665789
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.