#3585
Re: Análisis de Pharmamar (PHM), antigua Zeltia
Tiene sentido.
ATLANTIS is a global Phase III trial, with 154 sites in the USA, Canada, Latin America and Europe. Trial enrollment started in September 2016. The prospective assumptions are a one-sided 2.5% significance level with at least 90% power to detect a 25% decrease in the risk of death to be achieved with the experimental arm (HR: 0.75). The OS with either CAV or topotecan is expected to be 7.5 months [10]. To obtain the required 508 death events, approximately 600 patients with SCLC who failed one prior platinum-containing chemotherapy line will be stratified and randomized at a 1:1 ratio. The study reached its target enrollment of 600 randomized patients on 30 July 2018.