LUME-Lung 1 – Nintedanib Plus Docetaxel vs Placebo Plus Docetaxel in Non-Small Cell Lung Cancer After First-Line Chemotherapy Failure

Multicentre, randomised, double-blind, Phase III trial to investigate the efficacy and safety of oral nintedanib plus standard docetaxel therapy compared with placebo plus standard docetaxel therapy in patients with Stage IIIB/IV recurrent non-small cell lung cancer (NSCLC) after failure of first-line chemotherapy.

Trial CTgov-Identifier: NCT00805194


Histologically or cytologically confirmed Stage IIIB/IV recurrent NSCLC (all histologies)

Relapse or failure of one first-line chemotherapy

Eastern Cooperative Oncology Group performance status of 0–1

N = 1314

Randomisation 1:1
Histologies were balanced between treatment arms (adenocarcinoma n=658 [50.1%]; squamous cell carcinoma n=555 [42.2%]; other n=101 [7.7%])

  • Nintedanib 200 mg 
    Oral twice daily (Days 2–21 of 
    every 3-week cycle)
    Standard chemotherapy 
    with docetaxel 75 mg/m2
    Intravenous (IV; Day 1)

  • Placebo 200 mg 
    Oral twice daily (Days 2–21 of 
    every 3-week cycle) 
    Standard chemotherapy 
    with docetaxel 75 mg/m2
    IV (Day 1)


Primary outcome measures:
Progression-free survival (PFS), assessed by independent central review

Key secondary outcome measure:
Overall survival (OS)

Additional secondary outcome measures:
PFS (investigator-assessed) Objective response rate Disease control rate Patient-reported outcomes and health-related quality of life Pharmacokinetics


PFS, intent-to-treat population (all histologies):
Median PFS was 3.4 months for nintedanib plus docetaxel and 2.7 months for placebo plus docetaxel (hazard ratio [HR]=0.79; 95% confidence interval [CI]: 0.68–0.92; p=0.0019) regardless of histology.

Whilst there was no significant OS difference for the overall patient population, a prespecified analysis of OS identified a significant OS benefit beyond 1 year with nintedanib plus docetaxel in patients with adenocarcinoma compared with placebo plus docetaxel.


Nintedanib plus docetaxel significantly improved PFS for patients with advanced NSCLC of all histologies, and provided a significant OS benefit for patients with adenocarcinoma beyond 1 year, following progression after initial chemotherapy.


Reck M, Kaiser R, Mellemgaard A, et al. Docetaxel plus nintedanib versus docetaxel plus placebo in patients with previously treated non-small-cell lung cancer (LUME-Lung 1): a phase 3, double‑blind, randomised controlled trial. Lancet Oncol 2014;15(2):143–155.

Reck M, Mellemgaard A, von Pawel J, et al. Anti-angiogenic-specific adverse events in patients with non-small cell lung cancer treated with nintedanib and docetaxel. Lung Cancer 2015;90(2):267–273. (Accessed: February 2017).