Safety and feasibility of carboplatin and paclitaxel in combination with nintedanib for non-small cell lung cancer patients with idiopathic pulmonary fibrosis: a prospective pilot study.

Background: Idiopathic pulmonary fibrosis (IPF) is a risk factor for mortality in patients with lung cancer. Nintedanib has been known to slow down the decline of lung function and reduce IPF exacerbation. We aimed to explore the feasibility of adding nintedanib to chemotherapy for non-small cell lung cancer (NSCLC) patients with IPF. Methods: Chemotherapy-naïve stage III or IV NSCLC patients with IPF were prospectively enrolled and received carboplatin plus paclitaxel with nintedanib. Primary endpoint was incidence of treatment-related acute exacerbation of IPF within 8 weeks after the last administration of chemotherapy. We initially planned to enroll 30 patients and consider it feasible when the incident rate is less than 10%. Secondary endpoint was progression-free survival (PFS), overall survival (OS), overall response rate (ORR) and disease control rate (DCR). Results: After 27 patients were enrolled, trial was early terminated because 4 patients (14.8%) experienced exacerbation. Median PFS and OS were 5.4 months [95% confidence interval (CI): 4.6-9.3] and 15.8 months (95% CI: 12.2-30.1), respectively. ORR and DCR were 40.7% (95% CI: 24.5-59.2%) and 88.9% (95% CI: 71.9-96.1%), respectively. One patient discontinued trial treatment due to neuropathy. Conclusions: Although the primary endpoint was not met, there might be a survival benefit. The addition of nintedanib to chemotherapy might be useful in selected population.