Expansion platform type II: testing a treatment strategy
Mené en France sur 741 patients atteints d'une tumeur solide métastatique réfractaire aux traitements de référence, cet essai de phase II (SHIVA) évalue l'efficacité, du point de vue de la survie sans progression, et la toxicité de diverses thérapies ciblées administrées sur la base d'une analyse génomique de la tumeur métastatique
In The Lancet Oncology, Christophe Le Tourneau and colleagues report the results of SHIVA, a next-generation clinical trial and the first example of a trial using the expansion platform design type IIB. Several trial designs have emerged to address the challenges associated with the implementation of targeted therapies. Briefly, so-called exploratory platform designs (eg, BATTLE and I-SPY2) start by randomly assigning patients to several treatment groups, and during the course of the trial, further test newly discovered biomarker–drug signals in an exploratory and adaptive fashion.
The Lancet Oncology , commentaire, 2014