Randomized phase II trial of Cemiplimab plus OSE2101 (TEDOPI®) as maintenance therapy in ctDNA positive NSCLC.
Key facts
- Where
- Aviano, Bari, Catania, Genoa, Meldola, Modena, Monza, Naples, Novara, Pavia, Perugia, Reggio Emilia, Rome, Varese és Verona, OlaszországSee the 15 sites
- Phase
- 2. fázis
Where in Olaszország
- Centro di Riferimento Oncologico di AvianoAviano, OlaszországTaking people
- Istituto Tumori Bari Giovanni Paolo IIBari, OlaszországTaking people
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di CataniaCatania, OlaszországTaking people
- IRCCS Ospedale Policlinico San MartinoGenoa, OlaszországTaking people
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.lMeldola, OlaszországTaking people
- Azienda Ospedaliero - Universitaria di ModenaModena, OlaszországTaking people
- Fondazione IRCCS San Gerardo dei TintoriMonza, OlaszországTaking people
- IRCCS Istituto Nazionale Tumori Fondazione PascaleNaples, OlaszországTaking people
- Azienda Ospedaliero Universitaria Maggiore della CaritàNovara, OlaszországTaking people
- Fondazione IRCCS Policlinico San MatteoPavia, OlaszországTaking people
- Azienda Ospedaliera di PerugiaPerugia, OlaszországTaking people
- AUSL di Reggio Emilia IRCCS, Arcispedale Santa Maria Nuova di Reggio EmiliaReggio Emilia, OlaszországTaking people
- I.F.O. Istituti Fisioterapici OspitalieriRome, OlaszországTaking people
- Azienda Ospedaliera Ospedale Di Circolo E Fondazione MacchiVarese, OlaszországTaking people
- Azienda Ospedaliera Universitaria Integrata VeronaVerona, OlaszországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondazione Ricerca Traslazionale
- Trial code
- EU 2024-519262-42-00
- Record updated
- 2026. október 19.
- Original description
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.Read full original descriptionShow less
A Randomized phase II trial of Cemiplimab plus OSE2101 (TEDOPI®) as maintenance therapy in ctDNA positive NSCL. The Cemited study.
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.
Inclusion: 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.
Exclusion: Symptomatic or not previously treated and not stable brain metastases. Brain metastases are allowed if asymptomatic or pretreated; 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); Evidence of EGFR mutations or ALK or ROS1 rearrangements; Patients not candidate for chemoimmunotherapy; HLA-A2 negative; Tumor tissue not available (archive or collected before trial inclusion); Performance status >1 (ECOG).