Treatment rationale and design for J-SONIC: a randomized study of carboplatin plus nab-paclitaxel with or without nintedanib for advanced non–small cell lung cancer with idiopathic pulmonary fibrosis

Abstract We here describe the treatment rationale and procedure for a randomized study (J-SONIC; UMIN-CTR ID, UMIN000026799) of carboplatin plus nab-paclitaxel with or without nintedanib for patients with advanced non–small cell lung cancer (NSCLC) and idiopathic pulmonary fibrosis (IPF). The study was designed to examine the efficacy and safety of nintedanib administered in combination with carboplatin plus nab-paclitaxel, as compared with carboplatin plus nab-paclitaxel alone, in chemotherapy-naïve patients with advanced NSCLC associated with IPF. Eligible patients (enrollment target of n = 170) are randomized at a 1:1 ratio to receive four cycles of carboplatin (area under the curve of 6 on day 1) plus nab-paclitaxel (100 mg/m2 on days 1, 8, and 15) administered every 3 weeks either without (arm A) or with (arm B) nintedanib (150 mg b.i.d., daily), to be followed in arm B by single-agent administration of nintedanib (150 mg b.i.d., daily). This trial is the first randomized controlled study for treatment of NSCLC associated with IPF. The goal of the study is to demonstrate that nintedanib in combination with carboplatin plus nab-paclitaxel prolongs time to acute exacerbation of IPF compared with carboplatin plus nab-paclitaxel alone.