United States-based Spectrum Pharmaceuticals has completed enrolment of cohort 1 (N=87) for earlier treated non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations with sites across the US, Europe, and Canada, it was reported yesterday.
The EGFR earlier treated cohort is part of the ZENITH20 trial, an open-label, multi-centre, global Phase two trial assessing NSCLC patients with EGFR or HER2 exon 20 insertion mutations. Results from this cohort are likely to be revealed by the second half of 2019.
This study includes four cohorts, each of which is independently powered for a pre-specified statistical hypothesis. There are two cohorts in the earlier-treated NSCLC patients setting and two in the first-line setting. The primary endpoint is objective response rate. Additional endpoints include duration of response, disease control rate, progression-free survival and safety.
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