Randomized phase III trial of paclitaxel/carboplatin with or without PF-3512676 as first line treatment of advanced non-small cell lung cancer (NSCLC)

8016 Background: Paclitaxel/carboplatin (PC) is standard first line therapy for patients (pts) with Stage IIIB/IV NSCLC. PF- 3512676 (PF-676) is an oligodeoxynucleotide toll-like receptor 9 (TLR9) agonist. In a randomized phase 2 trial, addition of PF-676 to first line taxane/platinum chemotherapy produced a higher objective response rate and a trend toward improved overall survival (OS) in pts with advanced NSCLC. Confirmatory phase 3 trials were subsequently conducted. Methods: Chemotherapy naive pts with Stage IIIB (pleural effusion) or Stage IV NSCLC, ECOG PS 0 or 1, measurable disease, adequate bone marrow, renal and hepatic function, no pre-existing autoimmune disease, no brain metastases and no chronic systemic corticosteroid therapy were included. All pts received P (200 mg/m2) and C (AUC 6) IV on D1 of each 21 day cycle (max 6 cycles). In the investigational arm pts also received PF-676 (0.2 mg/kg) SC on D 8 and 15 of each chemotherapy cycle and weekly thereafter until progression. The primary en...