NCT02855125

A Randomized Phase 2 Trial of TAS-114 in Combination With S-1 Versus S-1

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Taiho Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Randomization will take place once the consented patient has completed all the necessary baseline procedures and is deemed eligible for study entry. Treatment assignment will be done centrally using a dynamic allocation method (biased coin) via an interactive voice/web response system (IXRS) stratified by: * Geographical region (Region 1: Asian \[Japan\]; Region 2: Western \[Europe and US\]) * Histological subtypes (nonsquamous cell carcinoma \[including mixed\] and squamous cell carcinoma)

Conditions

• Advanced or Metastatic Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	TAS-114	TAS-114 was a modulator of 5-fluorouracil (5-FU).
DRUG	S-1	S-1 was designed to provide oral delivery of 5-FU and to reduce the rate of degradation of 5-FU in vivo.

Timeline

• Start date: 2016-08-29
• Primary completion: 2017-09-30
• Completion: 2017-11-30
• First posted: 2016-08-04
• Last updated: 2024-09-19
• Results posted: 2021-12-23

Locations

30 sites across 6 countries: United States, France, Italy, Japan, Poland, Spain

Regulatory

• FDA-regulated drug study