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In the BATTLE trial, 255 heavily pretreated non-small cell lung cancer (NSCLC) patients were randomised to one of four molecular targeted therapies, according to a biomarker profile determined from fresh tumour biopsies.
In the BATTLE trial, median PFS for patients with KRAS G12C or G12V mutations was significantly shorter than for those patients with all other KRAS mutations or wild-type KRAS (Ihle et al, 2012).
The Battle trial for personalizing therapy for lung cancer identified targets of high interest in treatment of lung cancer and using an adaptive randomized trial utilized real time biomarker analyses to predict sensitivity or resistance to targeted agents [ 22].
In terms of clinical trials, the mutually exclusive nature of the RTK/RAS alterations also renders it technically feasible to implement a multibiomarker-based trial, 63 in which multiple targeted compounds are tested in different biomarker-defined populations within a single trial design, as has been recently described for non-small-cell lung cancer (BATTLE trial).
In addition, this innovative adaptive trial design similar to Battle Trial will enable researchers to use early data from one set of patients to guide decisions about which treatments might be more useful for patients later in the trial, and eliminate ineffective treatments more quickly.
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These findings are currently being followed up in the BATTLE-2 trial, which hopes to look at pre-specified biomarkers and then conduct prospective testing for biomarker signatures [30].
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