# LUME-Lung 1

Source: https://onco.cc/trials/lume-lung-1/  
OnCo record `lume-lung-1` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

An oral drug against three angiogenic receptors added to second-line chemotherapy; it worked, but only in adenocarcinoma, which is how it is licensed.

## Summary

LUME-Lung 1 randomised 1,314 patients at 211 centres in 27 countries between December 2008 and February 2011 to docetaxel with nintedanib (655) or docetaxel with placebo (659), stratified by performance status, previous bevacizumab, histology and brain metastases. Overall survival was tested in a prespecified stepwise order: first in patients with adenocarcinoma who progressed within nine months of starting first-line therapy, then in all adenocarcinoma patients, then in everyone.

The primary endpoint was met: median progression-free survival 3.4 months (95 percent confidence interval 2.9 to 3.9) against 2.7 months (2.6 to 2.8), hazard ratio 0.79 (0.68 to 0.92, p=0.0019). Overall survival was significant in the adenocarcinoma populations of the hierarchy but not in the whole population, which is why the EU licence, granted in 2014, is restricted to adenocarcinoma after first-line chemotherapy and why there is no United States approval in lung cancer.

In England NICE TA347 (22 July 2015) recommends nintedanib with docetaxel for adenocarcinoma that has progressed after first-line chemotherapy, with the patient access scheme discount. Nintedanib's other life is as a treatment for idiopathic pulmonary fibrosis, for which it was approved in the United States in 2014.

## Fields

- Kind: Trial
- Status: mixed
- Last checked: 2026-09-25
- Registry id: NCT00805194
- Phase: 3
- Setting: Stage IIIB or IV recurrent non-small-cell lung cancer progressing after first-line chemotherapy: docetaxel 75 mg/m2 on day 1 with nintedanib 200 mg twice daily or placebo on days 2 to 21, every three weeks, with progression-free survival by independent central review as the primary endpoint and a stepwise overall survival hierarchy
- Sponsor: Boehringer Ingelheim
- Enrolled: 1314
- Result: Median progression-free survival 3.4 against 2.7 months (hazard ratio 0.79, p=0.0019); overall survival significant in the adenocarcinoma populations of the prespecified hierarchy but not overall.
- Outcomes: Progression-free survival (independent central review): Nintedanib with docetaxel 3.4 months vs Placebo with docetaxel 2.7 months, HR 0.79

## Sources

- ClinicalTrials.gov NCT00805194: https://clinicaltrials.gov/study/NCT00805194
- LUME-Lung 1 (Lancet Oncology 2014): https://doi.org/10.1016/S1470-2045(13)70586-2
- NICE TA347: nintedanib for previously treated non-small-cell lung cancer: https://www.nice.org.uk/guidance/ta347

## Connected records

- cancers: [Adenocarcinoma of the lung](https://onco.cc/cancers/lung-adenocarcinoma/), [Lung cancer (all types)](https://onco.cc/cancers/lung-cancer/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- technologies: [Anti-angiogenic therapy](https://onco.cc/technologies/antiangiogenic/), [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [VEGF / VEGFR](https://onco.cc/targets/vegf/)
- drugs: [Docetaxel](https://onco.cc/drugs/docetaxel/), [Nintedanib](https://onco.cc/drugs/nintedanib/)
- companies: [Boehringer Ingelheim](https://onco.cc/companies/boehringer-ingelheim/)
- trials: [REVEL](https://onco.cc/trials/revel/)

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