Phase I, safety, tolerability and preliminary efficacy study of tremelimumab (Trem) in combination with gefitinib (Gef) in EGFR-mutant (EGFR-mut) NSCLC (GEFTREM)

Abstract

Methods: Key inclusion criteria included advanced NSCLC with an EGFR-mut, progression after a response on any prior EGFR TKI (first line or beyond), adequate PS (0-1). The primary objective was to determine the safety and tolerability of the combination of Gef (oral 250mg once-daily) with escalating doses of Trem (starting dose of 3mg/kg IV every 4 weeks for 6 cycles and beyond every 12 weeks) and to establish a recommended phase 2 dose (RP2D). A rolling 6 design and a dose limiting toxicity (DLT) period of 42 days were applied. Three escalating doses of Trem were pre-planned (3, 6 and 10mg/kg).