EORTC ETOP randomized, phase 3 trial with anti PD 1 monoclonal antibody pembrolizumab versus placebo for patients with early stage non small cell lung cancer (NSCLC) after …

TPS8571Background: The benefit of adjuvant chemotherapy in NSCLC has plateaued at around 5.4% improvement in 5 year overall survival and is hampered by toxicities having a major impact on treatment compliance. Anti PD-1 inhibitors have proven efficacy, favorable safety, and have been registered for the treatment of advanced NSCLC. Immunotherapy approaches are hypothesized to work best in the context of minimal residual disease, making the adjuvant setting the ideal clinical scenario, potentially improving the cure rate after surgery. The objective of this trial is to prospectively investigate whether adjuvant treatment with pembrolizumab after completion of radical surgery and standard adjuvant chemotherapy as appropriate for stage IB (T ≥ 4 cm) -II-IIIA NSCLC patients improves outcome compared to placebo in the PD-L1high positive subgroup and overall population. Methods: Adaptive Study Design …