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An oral drug against three angiogenic receptors added to second-line chemotherapy; it worked, but only in adenocarcinoma, which is how it is licensed.
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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
1,314 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival (independent central review)primary | Nintedanib with docetaxel | 655 | 3.4 months | 0.79 (0.68 to 0.92) | 0.0019 | link |
| Placebo with docetaxel | 659 | 2.7 months |
Shares Nintedanib, Boehringer Ingelheim, Anti-angiogenic therapy, Small-molecule kinase inhibitors.
Shares Adenocarcinoma of the lung, VEGF / VEGFR, Anti-angiogenic therapy, Lung cancer (all types).
Shares Boehringer Ingelheim, Adenocarcinoma of the lung, Lung cancer (all types), Small-molecule kinase inhibitors.
Shares Adenocarcinoma of the lung, Docetaxel, Lung cancer (all types), Cytotoxic chemotherapy.
Shares Docetaxel, Anti-angiogenic therapy, Cytotoxic chemotherapy, Non-small-cell lung cancer.
Shares Docetaxel, Cytotoxic chemotherapy, Non-small-cell lung cancer.
Shares Adenocarcinoma of the lung, Docetaxel, Lung cancer (all types), Cytotoxic chemotherapy.
Shares Docetaxel, Small-molecule kinase inhibitors, Cytotoxic chemotherapy, Non-small-cell lung cancer.