LUME-Colon 1: A double-blind, randomized phase III study of nintedanib plus best supportive care (BSC) versus placebo plus BSC in patients with colorectal cancer (CRC) refractory to standard therapies.

TPS3625 Background: Clinical studies with anti-VEGF agents, such as regorafenib (R), demonstrate that angiogenesis is critical to CRC tumor growth and metastasis. R has provided proof of principle in patients (pts) with refractory CRC, but is associated with a specific safety profile; there is a need for effective alternative treatments with different safety profiles. Nintedanib (N) is a triple angiokinase inhibitor of VEGF, PDGF and FGF signaling. N is approved in the European Union for the treatment of pts with advanced adenocarcinoma NSCLC after 1st-line chemotherapy and has shown clinical benefit in trials in several tumor types. In a phase I study of N in CRC, a clinically relevant anti-angiogenic effect was observed in 67% of pts. These findings and a manageable safety profile provide a rationale to examine N in refractory CRC. The objective of this study (NCT02149108; 1199.52) is to evaluate the efficacy and safety of N in pts with refractory CRC after failure with standard chemotherapy and biologi...