Table 1.
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.