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LUME-Lung 1 clinical trial

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 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



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


Primary outcome measure:

  • 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.

Hazard ratio = 0.79 95% CI = 0.68–0.92
LUME-Lung 1: figure for progression-free survival (PFS) with nintedanib vs placebo


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.

LUME-Lung 1: figure for overall survival (OS) in adenocarcinoma patients with nintedanib vs placebo


For nintedanib plus docetaxel, the most frequent Grade ≥3 adverse events (AEs) were:

  • Diarrhoea (6.6%)
  • Reversible increases in alanine aminotransferase (7.8%)
  • Reversible increases in aspartate aminotransferase (3.4%)

Overall, there was a slightly greater incidence of AEs at Grade ≥3 for nintedanib plus docetaxel compared with placebo plus docetaxel (71.3% vs 64.3%), but withdrawals due to AEs were similar in both arms (22.7% vs 21.7%). There was a low incidence of class effects typically associated with antiangiogenic agents, such as hypertension, bleeding, perforation and thromboembolism, and rates were similar for both groups.


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. 


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4 (Accessed: July 2017).

*Nintedanib is approved in the EU under the brand name VARGATEF® for use in combination with docetaxel in adult patients with locally advanced, metastatic or locally recurrent NSCLC of adenocarcinoma tumour histology after first-line chemotherapy. For the full list of country-specific information please click here. Nintedanib is not approved in other oncology indications.