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A phase 3, randomized, double-blind, placebo-controlled, multicenter study of fruquintinib in Chinese patients with advanced nonsquamous non-small-cell lung cancer – The FALUCA study

Lung Cancer Jul 22, 2020

Lu S, Chen G, Sun Y, et al. - Since a phase 2 trial showed patients with locally advanced/metastatic nonsquamous non-small-cell lung cancer (NSCLC) who have progressed following second-line chemotherapy have significantly better progression-free survival (PFS) after treatment with fruquintinib (an orally active kinase inhibitor), researchers intended to verify fruquintinib’s efficacy in the same patient population by performing this phase 3 randomized, double-blind, multicenter trial. In a randomized manner, patients were given fruquintinib (n = 354) or placebo (n = 173) once daily for 3 weeks on-treatment, and 1 week off-treatment at a 2:1 ratio. Overall survival (OS) was the primary endpoint. In the fruquintinib and placebo groups, the median OS was estimated to be 8.9 months and 10.4 months, respectively, and median PFS was 3.7 months and 1.0 months, respectively. Improved quality of life was reported in patients receiving fruquintinib. Overall, the primary endpoint was not met, but fruquintinib's efficacy when administered in combination with other agents was still suggested in treating NSCLC patients who have failed second-line chemotherapy.

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