A randomized, phase 3 trial with anti-PD-1 monoclonal antibody pembrolizumab (MK-3475) versus placebo for patients with early stage NSCLC after resection and completion of standard adjuvant therapy (PEARLS)
Automatisch geschlossen · 2016 bis 2020
Primary/co-primary. To prospectively investigate whether adjuvant treatment with pembrolizumab after completion of radical surgery (lobectomy/pneumonectomy) with or with-out standard adjuvant chemotherapy for stage IB (T ≥ 4 cm) -II-IIIA NSCLC patients improves Disease Free Sur-vival (DFS), as assessed locally by the investigator, com-pared to placebo in the PD-L1 strong positive subgroup and overall population.
♦ To prospectively compare DFS as assessed by the in-vestigator in the PD-L1 positive population;
♦ To prospectively determine and compare OS in the PD-L1 strong positive and overall population;
♦ To prospectively determine and compare OS in the PD-L1 positive population;
♦ To prospectively determine and compare the Lung Can-cer Specific Survival (LCSS) in the whole population irre-spective of PD-L1 expression status;
♦ To prospectively assess the safety of pembrolizumab after radical surgery followed by standard adjuvant chemo-therapy.