Pembrolizumab in patients with non-small-cell lung cancer of performance status 2 (PePS2) - a single arm, phase 2 trial

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Abstract

Therapeutic blockade of the axis of programmed cell death 1 (PD-1) and its ligand (PD-L1) has transformed the management of non-small-cell lung cancer (NSCLC). Clinical trials with pembrolizumab have enrolled patients with performance status (PS) 0–1. However, around 18% of patients with NSCLC are PS2, and the activity and safety of pembrolizumab in these patients is unclear. We aimed to evaluate the safety and efficacy of pembrolizumab in these patients.

Publication
Lancet Respiratory Medicine

About this publication

I became involved in the PePS2 trial shortly after joining CRCTU in 2014. I developed a Bayesian statistical method for this trial that would analyse co-primary efficacy and toxicity outcomes whilst adjusting for baseline covariates as a substantial part of my PhD thesis. This publication is important to me because PePS2 became the first trial where I published a statistical design paper and results paper.

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Kristian Brock
Principal Biostatistician

I am an academic early phase clincial trial statistician.

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