SHS_492347 WESH CTAI 16158

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

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.

Select Inclusion Criteria:

•Age ≥ 18 years old (≥ 20 years old in Japan);
•Histologically diagnosed or cytologically proven advanced or metastatic NSCLC patients or recurrent disease following radiation therapy or surgical resection;
•Patients who had received at least 2 prior therapies for advanced or metastatic disease condition
•Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (Version 1.1, 2009);
•Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
•Predicted life expectancy of at least 3 months;
•Able to take medications orally;
•Adequate organ function
•Willing and able to comply with required scheduled visits and study procedures.

Select Exclusion Criteria:

•Major surgery within prior 4 weeks and minor surgery within 7 days;
•Radiotherapy for extended field within prior 4 weeks or limited field within prior 2 weeks;
•Any anticancer therapy or investigational agent within prior 3 weeks.
•A serious illness or medical condition
•Concomitant treatment with certain drugs that may interact with S-1 (see protocol)
•Known hypersensitivity to S-1 or its metabolites (e.g., 5-FU);
•Previous use of TAS-114, S-1, and 5-FU drugs;
•Pregnant or lactating female or possibly pregnant women, or men or women wishing to have children during the study period;
•Judgment of the investigator that the patient is inappropriate for study participation.
Phase II
Cancer, All Other
Howard (Jack) West, M.D.
Taiho Oncology, Inc
Andrew Smith
  • Swedish Medical Center