• Edward S Kim, James Moon, Roy S Herbst, Mary W Redman, Shaker R Dakhil, Mario R Velasco, Fred R Hirsch, Philip C Mack, Karen Kelly, John V Heymach, and David R Gandara.
• *Levine Cancer Institute, Charlotte, North Carolina; †SWOG Statistical Center, Seattle, Washington; ‡Yale Cancer Center, New Haven, Connecticut; §Cancer Center of Kansas and Wichita CCOP, Wichita, Kansas; ‖Central Illinois CCOP and Cancer Care Specialists, Decatur, Illinois; ¶University of Colorado Cancer Center, Aurora, Colorado; #University of California Davis Cancer Center, Sacramento, California; and **MD Anderson Cancer Center, Houston, Texas.
• J Thorac Oncol. 2013 Dec 1; 8 (12): 1519-28.

IntroductionCetuximab and bevacizumab have each been demonstrated to prolong survival when added to chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC). However, the potential benefit of combining cetuximab and bevacizumab together with a platinum-based doublet had not been explored. We designed this phase II trial to evaluate the safety, tolerability, and efficacy of the combination of carboplatin, paclitaxel, cetuximab, and bevacizumab in chemotherapy-naive patients with advanced, nonsquamous NSCLC.MethodsPatients received with up to six cycles of carboplatin (area under curve 6), paclitaxel (200 mg/m(2)), cetuximab (400 mg/m(2) day 1 then 250 mg/m(2) weekly), and bevacizumab (15 mg/kg) every 21 days. Patients with an objective response or stable disease received maintenance cetuximab (250 mg/m(2) weekly) and bevacizumab (15 mg/kg every 21 days) until disease progression. The primary endpoint was safety as defined by the frequency and severity of hemorrhagic toxicities. Secondary endpoints included response rate, progression-free survival, overall survival, and toxicity. Molecular biomarkers were assessed in an exploratory manner.ResultsThe primary endpoint of grade 4 or higher hemorrhage of 2% (95% confidence interval: 0%-7%) met prespecified criteria for safety. One hundred ten patients were enrolled. There were four treatment-related deaths including lung hemorrhage (2), infection (1), and unknown (1). Median progression-free survival was 7 months and median overall survival was 15 months. The response rate was 56% with an overall disease control rate of 77%.ConclusionThis regimen was safe, feasible, and effective as a frontline treatment of advanced NSCLC, providing the basis for the ongoing phase III trial S0819.

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