190TiP: ELUXA 1: Phase II study of BI 1482694 (HM61713) in patients (pts) with T790M-positive non-small cell lung cancer (NSCLC) after treatment with an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI).

BI 1482694 (HM61713) is an oral EGFR mutant-specific TKI which has shown encouraging clinical activity as well as favourable tolerability in pts with EGFR TKI pre-treated NSCLC harbouring a T790M mutation. A clinical programme has been initiated to evaluate BI 1482694 in various NSCLC treatment settings. This global Phase II trial is designed to further investigate the efficacy and safety of BI 1482694 in pts with NSCLC and acquired T790M-mediated resistance to first-line EGFR TKIs. This is an ongoing, single-arm, open-label, Phase II trial enrolling adult pts (≥20 years) with locally advanced or metastatic EGFR mutated NSCLC, disease progression following EGFR TKI therapy with or without additional lines of chemotherapy, centrally confirmed T790M-positivity in the tumour prior to study entry, and ECOG PS 0/1. Pts should not have received chemotherapy, hormonal therapy, or immunotherapy within 14 days, EGFR TKIs (including erlotinib, gefitinib, afatinib) within 10 days or 5-fold half-life, whichever is the longer, or any investigational agents within 28 days prior to study drug administration. Prior treatment with drugs targeting T790M mutants (e.g., AZD9291, CO-1686) is not allowed. Pts will receive oral BI 1482694 800 mg, with dose modification if required, once daily in 21-day cycles until disease progression, unacceptable toxicity, withdrawal or death. The primary endpoint is objective response rate according to RECIST v1.1 (independent central review). Secondary endpoints include disease control rate, duration of response, progression-free survival, overall survival, time to progression, tumour shrinkage, pt-reported outcomes, safety, and pharmacokinetics of BI 1482694. This trial was initiated in June 2015 and is currently recruiting pts in Republic of Korea, Malaysia, Philippines, Italy, Spain, Taiwan and the USA. Additional study locations will include Australia, Canada, and Germany, with an estimated total enrolment of 150 pts. Further details are available at ClinicalTrials.gov (NCT02485652). NCT02485652 Hanmi Pharmaceuticals Hanmi Pharmaceuticals in collaboration with Boehringer Ingelheim