Table 1. . Summary of the LUME-Lung 1 study: key points.

Factor	Details
Study design	International, randomized, double-blind, controlled Phase III study
Patients	1300 patients with advanced NSCLC who had progressed after first-line chemotherapy
Treatments	Docetaxel 75 mg/m2 by intravenous infusion on day 1, plus nintedanib 200 mg twice daily orally or matching placebo on days 2–21 of a 21-day cycle Treatment cycles were continued until patients experienced unacceptable AEs or disease progression
Primary end point: progression-free survival (PFS) – how long patients live with the disease without it getting worse – as determined by an independent central review panel	Nintedanib plus docetaxel was found to improve PFS significantly compared with placebo plus docetaxel in the overall patient population, regardless of histology as well as in patients with adenocarcinoma histology
Key secondary end point: overall survival (OS)	OS was also significantly improved in patients with adenocarcinoma NSCLC In the total adenocarcinoma population, median OS was greater than 1 year in the nintedanib plus docetaxel group and OS was significantly greater than in the placebo plus docetaxel group (median: 12.6 vs 10.3 months; HR: 0.83 [95% CI: 0.70–0.99]; p = 0.0359)
1-year survival probability	52.7% in the nintedanib plus docetaxel compared with 44.7% in the placebo plus docetaxel group
2-year survival probability	25.7% in the nintedanib plus docetaxel group compared with 19.1% in the placebo plus docetaxel group

AE: Adverse event; HR: Hazard ratio; OS: Overall survival; PFS: Progression-free survival.

Data taken from [7].