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

ConditionNSCLC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorFondazione Ricerca Traslazionale

About this trial

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

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Tedopi
  • Cemiplimab

Treatment groups

160 Participants
are divided into 2 treatment groups