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.
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
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)
Parallel
Tedopi
DrugCemiplimab + OSE2101 (TEDOPI®) (ARM B: experimental arm)
Cemiplimab
DrugCemiplimab +/-Pemetrexed (ARM A: standard arm)
ctDNA clearance rate
Differences in ctDNA clearance rate in the two arms of treatment Differences in ctDNA clearance rate in the two arms of treatment Differences in ctDNA clearance rate in the two arms of treatment Differences in ctDNA clearance rate in the two arms of treatment
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