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InOncology.com

NSCLC nintedanib 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

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

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LUME-Lung 1

Phase III
3
published

Stage IIIB/IV NSCLC (all histologies) after first-line chemotherapy

Nintedanib plus docetaxel vs placebo plus docetaxel

LUME-Lung 1
Stage IIIB/IV NSCLC after first-line

LUME-Lung 2

Phase III
3
published

Non-squamous NSCLC after first-line chemotherapy

Nintedanib plus pemetrexed vs placebo plus pemetrexed

LUME-Lung 2
Non-squamous NSCLC after first-line

LUME-BioNIS

Phase PA
PA
recruiting

Biomarker study in patients with NSCLC according to the approved label

Nintedanib plus docetaxel

LUME-BioNIS
Post-approval biomarker study in NSCLC

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.

Related information

Thoracic malignancies: additional analyses

An overview of the further subanalyses performed, including nintedanib treatment for patients with adenocarcinoma histology and in European patients

About nintedanib

A detailed look at nintedanib’s mechanism of action and the role of angiogenesis in cancer

References

1

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

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*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.