At a glance
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A Randomized, Open-Label, Multi-Center, International Phase 2 Study of TAS-114 in Combination With S-1 in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
In Brief
A Phase 2 clinical trial evaluating TAS-114 and S-1 for Advanced or Metastatic Non-small Cell Lung Cancer. Completed, enrolled 128 participants across 30 sites in 6 countries.
Detailed Summary
This is a randomized, open-label, Phase 2 study of TAS-114 administered in combination with S-1, to investigate the efficacy, safety and tolerability of the TAS-114/S-1 regimen in patients with advanced or metastatic NSCLC. The study will be conducted internationally in 2 regions: Asian \[Japan\] and Western \[Europe and US\]. Patients will be randomized into TAS-114/S-1 arm versus S-1 control arm in a 1:1 ratio.
Study Details
Timeline
Interventions
TAS-114 was a modulator of 5-fluorouracil (5-FU).
S-1 was designed to provide oral delivery of 5-FU and to reduce the rate of degradation of 5-FU in vivo.