Phase Ii Studies Of Nivolumab (Anti-Pd-1, Bms-936558, Ono-4538) In Patients With Advanced Squamous (Sq) Or Nonsquamous (Non-Sq) Non-Small Cell Lung Cancer (Nsclc).

8027 Background: Nivolumab, a fully human IgG4, PD-1 immune-checkpoint inhibitor antibody, has shown durable clinical activity in phase I and II trials in several tumor types. Recently, a phase III study (CheckMate -017) demonstrated that nivolumab improved overall survival than docetaxel in second-line of sq NSCLC. Here, we report the results of two phase II studies to evaluate the efficacy and safety of nivolumab in previously treated advanced sq (JapicCTI-No.132072) and non-sq (JapicCTI-No.132073) NSCLC pts. Methods: Both studies require pts aged ≥ 20 years with ECOG status of 0 or 1, stage IIIB/IV, or recurrent NSCLC and at least one prior chemotherapy including platinum containing regimen.Pts received nivolumab 3 mg/kg IV Q2W until progression or unacceptable toxicity.The primary endpoint in both studies was the objective response rate (ORR) (RECIST v1.1).Planned sample size was 30 pts for Sq and 67 pts for Non-sq, respectively(P0=0.09, P1=0.26 , P0=0.09, P1=0.20 ; α=0.025 (one-side) , 1-β=0.8). Resu...