Randomized, phase III trial of figitumumab in combination with erlotinib versus erlotinib alone in patients with non-adenocarcinoma non-small cell lung cancer.

Figitumumab (CP-751,871) is a fully human IgG2 monoclonal antibody that inhibits the insulin-like growth factor 1 receptor. This multicenter, randomized, phase III study investigated the efficacy of figitumumab plus erlotinib compared with erlotinib alone in patients with pretreated, non-small cell lung cancer (NSCLC). PATIENTS AND METHODS: Patients (stage IIIB/IV or recurrent disease with non-adenocarcinoma histology) who had previously received at least one platinum-based regimen were randomized to receive open-label figitumumab (20 mg/kg) plus erlotinib 150 mg/day or erlotinib alone every 3 weeks. The primary endpoint was overall survival (OS). RESULTS: Of 583 patients randomized, 579 received treatment. The study was closed early by an independent data safety monitoring committee due to results crossing the pre-specified futility boundary. At the final analysis, median OS was 5.7 months for figitumumab plus erlotinib and 6.2 months for erlotinib alone (hazard ratio [HR], 1.09; 95% confidence interval [CI], 0.91 to 1.31; p=0.35). Median progression-free survival was 2.1 months for figitumumab plus erlotinib and 2.6 months for erlotinib alone (HR, 1.08; 95% CI, 0.90 to 1.29; p=0.43). Treatment-related non-fatal serious adverse events occurred in 18% and 5% of patients in the figitumumab arm or erlotinib alone arm, respectively. There were nine treatment-related deaths (three related to both drugs, four related to erlotinib alone and two related to figitumumab). CONCLUSIONS: The addition of figitumumab to erlotinib did not improve OS in patients with advanced, pretreated, non-adenocarcinoma NSCLC. Clinical development of figitumumab has been discontinued.