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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.

PROFID EHRA
PRevention Of sudden cardiac death aFter myocardial Infarction by Defibrillator im-
plantation

To demonstrate that in post-MI patients with symptomatic heart failure who receive optimal medical therapy (OMT) for this condition, and with reduced LVEF <=35%, OMT without implantable cardioverter defibrillator (ICD) implantation (index…