Table 1.

Summary of key efficacy and safety results from Phase II and III studies with nintedanib in patients with NSCLC

Study	Setting	Regimen	Median PFS	Median OS	Most common AEs
Phase II66	Advanced NSCLC, previously treated	Nintedanib 150 mg (bid, n=36) or 250 mg (bid, n=37)	6.9 weeks	21.9 weeks	Nausea, diarrhea, vomiting, anorexia, abdominal pain
Phase III67 LUME-lung 1	Advanced NSCLC, previously treated	Nintedanib (200 mg, bid, 2–21 days) + docetaxel (75 mg/m2, day 1), n=565 or placebo + docetaxel (75 mg/m2, day 1), n=569	3.4 months vs 2.7 months, P=0.0019 (nintedanib vs placebo)	12.6 months vs 10.3 months, P=0.0359 (nintedanib vs placebo arm)	The more common AEs in the nintedanib vs placebo: diarrhea (42.3% vs 21.8%), increase in ALT (28.5% vs 8.4%), increase in AST (22.5% vs 6.6%), nausea (24.2% vs 18%), vomiting (16.9% vs 9.3%)
Phase III68 LUME-lung 2	Advanced NSCLC or nonsquamous histology, after relapse or failure of first-line chemotherapy	Nintedanib (200 mg, bid, 2–21 days) + pemetrexed (500 mg/m2, day 1), n=353 or placebo + pemetrexed (500 mg/m2, day 1), n=360	4.4 months vs 3.6 months, P=0.0435 (nintedanib vs placebo)	12.2 months vs 12.7 months, P=0.7921 (nintedanib arm vs placebo arm)	Nintedanib vs placebo: grade 3/4 AEs (increase in liver enzymes and gastrointestinal events; 58.5% vs 42.3%), serious AEs (30% vs 32.8%), grade 5 AEs (9.8% vs 12%)

Abbreviations: AEs, adverse events; bid, twice daily; NSCLC, non-small cell lung cancer; OS, overall survival; PFS, progression free survival.