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InOncology.com

Thoracic malignancies: clinical trials

Nintedanib* has been investigated in lung cancer as part of the LUME-Lung clinical trial programme. Within this section you will find an overview of the main trials within this programme as well as links to pages for further information.

Nintedanib clinical trials in thoracic malignancies

The approval of nintedanib for the treatment of adult patients with advanced, metastatic or locally recurrent NSCLC of adenocarcinoma histology after first-line chemotherapy is based on the Phase III LUME-Lung 1 trial.1

Nintedanib is being investigated in patients with unresectable MPM within the LUME-Meso Phase II/III trial. Based on the Phase II results,2 nintedanib received orphan drug designation for the treatment of malignant pleural mesothelioma (MPM) from the US Food & Drug Administration providing 7-year marketing exclusivity if approved.3,4 The Phase III part of the LUME-Meso trial of nintedanib plus pemetrexed/cisplatin vs placebo plus pemetrexed/cisplatin for the treatment of patients with unresectable MPM is currently recruiting patients with epithelioid histology.5

 

The following table shows the clinical trials of nintedanib in NSCLC and MPM; you can find links to further information on this site and published papers.

Ongoing clinical trials

Nintedanib thoracic malignancies ongoing trials

DLT, dose-limiting toxicity; MTD, maximum tolerated dose; NSCLC, non-small cell lung cancer; PK/PD, pharmacokinetics/pharmacodynamics.

References

1

Reck M, et al. Lancet Oncol 2014;15(2):143-55.

2

Grosso F, et al. J Clin Oncol 2017. In press.

3

US Food & Drug Administration. Nintedanib orphan drug designation, 12 December 2016. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=547916. Accessed: July 2017.

4

US Food & Drug Administration. e-CFR 21 PART 316 Orphan Drug & the Orphan Drug Act 1983.  https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/HowtoapplyforOrphanProductDesignation/ucm124562.htm. Accessed: July 2017.

5

Scagliotti GV, et al. Clin Lung Cancer 2017; Mar 22. pii: S1525-7304(17)30087-6. [Epub ahead of print]. https://doi.org/10.1016/j.cllc.2017.03.010. 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. Nintedanib is being investigated in malignant pleural mesothelioma (MPM) and is not approved for this use. The efficacy and safety of nintedanib in MPM have not been established.