2024-519262-42-00RecruitingPhase 2
Randomized phase II trial of Cemiplimab plus OSE2101 (TEDOPI®) as maintenance therapy in ctDNA positive NSCLC.
A Randomized phase II trial of Cemiplimab plus OSE2101 (TEDOPI®) as maintenance therapy in ctDNA positive NSCL. The Cemited study.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 19 Oct 2026
Brief summary (registry, in English)
to determine ctDNA clearance in TEDOPI plus cemiplimab versus cemiplimab +- pemetrexed (standard maintenance arm) in patients with HLA-A2 positive NSCLC not progressing after 4 cycles of chemoimmunotherapy.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 23 Dec 2024
- Start date
- 15 Jul 2025
- Lead sponsor
- Fondazione Ricerca Traslazionale
- Diseases
- Lung cancer
- EU CT number
- 2024-519262-42-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 90
- 15 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or metastatic non-small-cell lung cancer who are HLA-A2 positive and could have chemotherapy with immunotherapy as first treatment.
- Age
- 18 years or older.
- Sex
- Men and women can join.
- Disease stage
- Advanced, locally advanced or metastatic non-small-cell lung cancer without driver gene changes. Locally advanced disease must be unable to have chemoradiation meant to treat it fully.
- Earlier treatment
- Can have chemotherapy with immunotherapy as first treatment. The summary says people join if the disease has not progressed after 4 cycles of it.
- Biomarker or test result
- HLA-A2 positive. No EGFR mutation, no ALK or ROS1 rearrangement. Tumour tissue must be available.
Main reasons for not taking part
- HLA-A2 negative
- EGFR mutation, or ALK or ROS1 rearrangement
- ECOG performance status above 1
- Brain metastases that cause symptoms, or are untreated and not stable
- Another cancer in the last 3 years, with a few exceptions
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Symptomatic or not previously treated and not stable brain metastases. Brain metastases are allowed if asymptomatic or pretreated
Other illness
- 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)
Lab values
- Evidence of EGFR mutations or ALK or ROS1 rearrangements
Other
- Patients not candidate for chemoimmunotherapy
- HLA-A2 negative
- Tumor tissue not available (archive or collected before trial inclusion)
- Performance status >1 (ECOG)
Who the study is looking for
- 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 chemoimmunotherapy irrespective of PD-L1 levels
- HLA-A2 positive
- ECOG PS 0-1
- Signed informed consent (IC) prior to any trial-specific procedures.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro di Riferimento Oncologico di Aviano | Aviano | Italy | Recruiting |
| Istituto Tumori Bari Giovanni Paolo II | Bari | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania | Catania | Italy | Recruiting |
| IRCCS Ospedale Policlinico San Martino | Genoa | Italy | Recruiting |
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l | Meldola | Italy | Recruiting |
| Azienda Ospedaliero - Universitaria di Modena | Modena | Italy | Recruiting |
| Fondazione IRCCS San Gerardo dei Tintori | Monza | Italy | Recruiting |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale | Naples | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Maggiore della Carità | Novara | Italy | Recruiting |
| Fondazione IRCCS Policlinico San Matteo | Pavia | Italy | Recruiting |
| Azienda Ospedaliera di Perugia | Perugia | Italy | Recruiting |
| AUSL di Reggio Emilia IRCCS, Arcispedale Santa Maria Nuova di Reggio Emilia | Reggio Emilia | Italy | Recruiting |
| I.F.O. Istituti Fisioterapici Ospitalieri | Rome | Italy | Recruiting |
| Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi | Varese | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Integrata Verona | Verona | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.