1219TiPOPEN, SINGLE ARM TRIAL OF ERLOTINIB AS THE 2ND/3RD LINE TREATMENT IN ADVANCED OR RECURRENT NON-SMALL CELL LUNG CANCER WITH EPIDERMAL GROWTH FACTOR RECEPTOR WILD TYPE AND C-MET NEGATIVE EXPRESSION (ML28941, C-TONG 1306)

ABSTRACT Background: Non-small cell lung cancer (NSCLC) patients harboring epidermal growth factor receptor (EGFR) mutations show excellent clinical benefit to Erlotinib. Since EGFR wild type constitutes approximately 70% NSCLC, it is also important to evaluatethe efficacy of Erlotinib in this group of patients. Preclinical study shows that c-Met over-expression could be the cause of EGFR-TKI primary and secondary resistance, which gives us a hint, that c-Met negative expression maybe feasible to exclude the purely resistant to EGFR TKIs,which could be considered as 2nd biomarker, as so called “bi-biomarker”.This concept is supported by a phase II study (OAM4558g, ASCO2011), which showed in patients withEGFR wild type and c-met negative expression population treated with Erlotinib had a longer duration of PFS versus Erlotinib plus Onartuzumab (2.7 vs. 1.4 months, stratified HR = 1.82; 95% CI: 0.99, 3.32). The aim of this study is to evaluate the efficacy and safety of erlotinib as the 2nd/3rd line treatment in stage IV NSCLC with EGFR wild type and c-met negative expression. Trial design: This is a multicenter, single arm phase II study. Stage IV NSCLC patients (aged ≥18 yand ≤75 y, ECOG PS ≤ 2) with EGFR wild type and c-met negative expression on Ventana benchmark instrument(≥50% of the cells do not stain or stain with weak intensity, clinical score 0 or 1+) were eligible if they have had at least one prior platinum-based chemotherapy regimen.The primary objective of the study was 6-month progression free survival (PFS) rate. Secondary end-point include overall survival (OS), objective response rate (ORR), PFSand health-related quality of life (HRQoL). We estimated 6months PFS rate of experimental arm was 35% (OAM4558g, 2011ASCO), and historical control is estimated to be 20% (BR.21 and TAILOR), considering 10% total dropout rate, adjusting two-sided a = 0.05, power 80%. A total of 54 enrollments will be needed. All patients will receive once-daily oral Erlotinib (150mg) until disease progression or intolerable toxicities.The study has been registered on the ClinicalTrials.gov (NCT02006043) and the recruitment has begun in January 2014. Up to now, one patient has been recruited. The trial will be finished at July 2016 (12months recruitment and 18 months follow-up). Disclosure: Z. Li: The research is sponsored by the Roche. All other authors have declared no conflicts of interest.