Phase I study of INC280 plus erlotinib in patients with MET expressing adenocarcinoma of the lung.

2587 Background: MET dysregulation is one mechanism of EGFR-TKI (epidermal growth factor receptor-tyrosine kinase inhibitor) resistance in patients (pts) with EGFR mutated lung cancer. INC280 is a potent oral small molecular inhibitor of the MET kinase. Inhibiting both pathways may circumvent EGFR-TKI resistance. A phase I study of INC280 plus erlotinib (E) to determine the maximum tolerated dose, dose limiting toxicity (DLT), pharmacokinetics (PK) and preliminary antitumor activity of this combination was conducted. Methods: Using a 3 + 3, dose escalation design, INC280 was increased over 5 dose levels (DL) from 100 - 600 mg po bid. Daily E was given at 100 mg in DL1 and 150 mg in DL2- 5. Both agents were given for 28 days (1 cycle). Key eligibility included: lung adenocarcinoma with MET expression by a CLIA certified lab, age ≥ 18 years old, ECOG PS of ≤ 2, acceptable organ function, and > 1 systemic therapy for advanced disease. Results: 18 pts have been treated on 5 dose levels. Pt characteristics: me...