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MUC-FIRE

The aim of this study is to assess the effects of mucous fistula refeeding in a prospective randomized trial. We hypothesize that MFR between enterostomy creation and enterostomy closure reduces the time to full enteral feeds after enterostomy…

Clinical Performance Study Plan (CPSP) for the use of GenDx CDx Tedopi for subject enrollment on to the OSE Immunotherapeutics Phase 3 trial (OSE2101C302) of OSE2101 versus docetaxel in HLA-A*02 positive patients with metastatic Non-Small Cell Lung Cancer (NSCLC) and secondary resistance to immune checkpoint inhibitor (ARTEMIA)

This clinical performance study/clinical investigation will evaluate the safety and effectiveness of GenDx CDx Tedopi in identifying HLA-A*02 status in metastatic NSCLC subjects who may be eligible for treatment with OSE2101.