Veliparib (Abt-888) Or Placebo Combined With Carboplatin And Paclitaxel In Patients With Previously Untreated Advanced/Metastatic Squamous (Sq) Non-Small Cell Lung Cancer (Nsclc): A Randomized Phase 3 Trial.

TPS8107 Background: NSCLC is often diagnosed at an advanced stage, conferring a poor prognosis. The current standard of care for first-line treatment comprises platinum-based regimens. Veliparib is a potent, orally bioavailable PARP1/2 inhibitor that can delay DNA repair following damage induced by chemotherapeutic agents. In preclinical tumor models, veliparib has been shown to enhance antitumor activity of carboplatin, and phase 1 data show that it can be safely combined with carboplatin and paclitaxel. A phase 2 study indicated favorable efficacy for veliparib plus carboplatin and paclitaxel vs placebo plus carboplatin and paclitaxel in the subgroup of patients with Sq NSCLC (Ramalingam et al. Ann Oncol 2014;25(Suppl 4):1234P). Based on these results, this phase 3 pivotal trial has been initiated. Methods: This is a randomized, double blind, multicenter, phase 3 trial (NCT02106546). Patients ( ≥ 18 years) who have received no prior chemotherapy or chemoradiotherapy for advanced/metastatic Sq NSCLC are ...