Boehringer Ingelheim has started patient enrolment in a new global Phase III trial (LUME-COLON 1) of nintedanib to treat advanced colorectal cancer (CRC).

The double-blind, randomised, placebo-controlled LUME-COLON 1 trial will evaluate the efficacy and safety of nintedanib plus best supportive care (BSC), versus placebo plus BSC, after previous treatment with standard chemotherapy and biological agents.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

The new trial builds on the early efficacy signs observed with nintedanib in CRC during Phase I/II trials.

Boehringer Ingelheim chief medical officer Dr Klaus Dugi said: "There is a significant need to improve treatment options for patients with advanced colorectal cancer and Boehringer Ingelheim is proud to conduct further research into this disease area.

"There is a significant need to improve treatment options for patients with advanced colorectal cancer and Boehringer Ingelheim is proud to conduct further research into this disease area."

"The initiation of LUME-COLON 1 reinforces our ongoing commitment to driving innovation in oncology research."

See Also:

The trial will enrol around 750 patients with CRC, whose disease has progressed on previous treatment and will be conducted at 150 sites worldwide, with locations in the US, Europe and Asia.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

During the trial, patients will be given either nintedanib 200mg twice daily plus BSC, or matching placebo plus BSC.

The co-primary endpoints of the trial will be progression-free survival (PFS), evaluated by blinded review and overall survival (OS), while secondary endpoints are objective tumour response rate and disease control rate.

In the European Union (EU), the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the approval of nintedanib in combination with docetaxel to treat adult patients with locally advanced, metastatic or locally recurrent NSCLC of adenocarcinoma tumour histology after first line chemotherapy.

The company has also submitted another EU marketing authorisation application (MAA) for nintedanib in the treatment of idiopathic pulmonary fibrosis (IPF).

The US Food and Drug Administration (FDA) has approved nintedanib capsules under the brand name OFEV for oral use to treat IPF.