Phase I/Ii Study Of Rilotumumab (R) And Erlotinib (E) In Previously Treated Patients (Pts) With Metastatic Nsclc.

8092 Background: MET is frequently overexpressed in NSCLC. Amplification of MET and its ligand (HGF), are mechanisms of resistance to EGFR inhibitors. R is an IgG2 human mAb that targets HGF. This phase I/II trial evaluated the safety and recommended phase 2 dose (RP2D) of R combined with E for pts with metastatic previously treated NSCLC (Phase I) and whether efficacy is high enough to warrant further interest (Phase II). Methods: Phase I adopted a dose de-escalation design with R starting at 15 mg/kg IV every 3 weeks and E 150 mg orally daily (dose level 0). If dose de-escalation was needed it would proceed according to Narayana k-in-a-row design where a selected dose was estimated by isotonic regression. RP2D was the maximum below the dose associated with a 25% DLT rate. Phase II intended to test whether disease control rate (stable disease or response, DCR) of 50% for E could be improved by adding R. A Simon 2 stage design was used to select the optimal sample size for type I and II error of .10. Twen...