RT Journal Article SR Electronic T1 Randomized, Placebo-Controlled, Phase II Study of Veliparib in Combination with Carboplatin and Paclitaxel for Advanced/Metastatic Non–Small Cell Lung Cancer JF Clinical Cancer Research JO Clin Cancer Res FD American Association for Cancer Research SP 1937 OP 1944 DO 10.1158/1078-0432.CCR-15-3069 VO 23 IS 8 A1 Ramalingam, Suresh S. A1 Blais, Normand A1 Mazieres, Julien A1 Reck, Martin A1 Jones, C. Michael A1 Juhasz, Erzsebet A1 Urban, Laszlo A1 Orlov, Sergey A1 Barlesi, Fabrice A1 Kio, Ebenezer A1 Keiholz, Ulrich A1 Qin, Qin A1 Qian, Jiang A1 Nickner, Caroline A1 Dziubinski, Juliann A1 Xiong, Hao A1 Ansell, Peter A1 McKee, Mark A1 Giranda, Vincent A1 Gorbunova, Vera YR 2017 UL http://clincancerres.aacrjournals.org/content/23/8/1937.abstract AB Purpose: PARP plays an important role in DNA repair. Veliparib, a PARP inhibitor, enhances the efficacy of platinum compounds and has been safely combined with carboplatin and paclitaxel. The primary endpoint of this phase II trial determined whether addition of veliparib to carboplatin and paclitaxel improved progression-free survival (PFS) in previously untreated patients with advanced/metastatic non–small cell lung cancer.Experimental Design: Patients were randomized 2:1 to carboplatin and paclitaxel with either veliparib or placebo. Veliparib (120 mg) or placebo was given on days 1 to 7 of each 3-week cycle, with carboplatin (AUC = 6 mg/mL/min) and paclitaxel (200 mg/m2) administered on day 3, for a maximum of 6 cycles.Results: Overall, 158 were included (median age, 63 years; male 68%, squamous histology 48%). Median PFS was 5.8 months in the veliparib group versus 4.2 months in the placebo group [HR, 0.72; 95% confidence interval (CI), 0.45–1.15; P = 0.17)]. Median overall survival (OS) was 11.7 and 9.1 months in the veliparib and placebo groups, respectively (HR, 0.80; 95% CI, 0.54–1.18; P = 0.27). In patients with squamous histology, median PFS (HR, 0.54; 95% CI, 0.26–1.12; P = 0.098) and OS (HR, 0.73; 95% CI, 0.43–1.24; P = 0.24) favored veliparib treatment. Objective response rate was similar between groups (veliparib: 32.4%; placebo: 32.1%), but duration of response favored veliparib treatment (HR, 0.47; 95% CI, 0.16–1.42; P = 0.18). Grade III/IV neutropenia, thrombocytopenia, and anemia were comparable between groups.Conclusions: Veliparib combination with carboplatin and paclitaxel was well-tolerated and demonstrated a favorable trend in PFS and OS versus chemotherapy alone. Patients with squamous histology had the best outcomes with veliparib combination. Clin Cancer Res; 23(8); 1937–44. ©2016 AACR.