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Boehringer starts Phase III colorectal cancer trial of nintedanib

Germany-based Boehringer Ingelheim has initiated patient enrollment in a new global Phase III trial called LUME-COLON 1 of nintedanib to treat advanced colorectal cancer (CRC).

The double-blind, randomized, 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.

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

Boehringer Ingelheim chief medical officer Professor Klaus Dugi said there is a significant need to improve treatment options for patients with advanced colorectal cancer.

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

The trial will enroll 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

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

The trial’s co-primary endpoints 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.