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

Inclusion Criteria

• •1. Age ≥ 18 years old (≥ 20 years old in Japan);
• •2. Histologically diagnosed or cytologically proven advanced or metastatic NSCLC patients, either Stage IIIB/Stage IV disease (according to Version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology), or recurrent disease following radiation therapy or surgical resection;
• •3. Patients who had received at least 2 prior therapies for advanced or metastatic disease condition, including platinum doublet and pemetrexed, docetaxel, or immunotherapy, and were refractory to or unable to tolerate their last prior therapy
• •4. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (Version 1.1, 2009);
• •5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
• •6. Predicted life expectancy of at least 3 months;
• •7. Able to take medications orally;
• •8. Adequate organ function
• •9. Women of childbearing potential (WOCBP) must have a negative pregnancy test (urine or serum) within 7 days prior to starting the study drug. Both males and females must agree to use effective birth control during the study (prior to the first dose and for 6 months after the last dose) if conception is possible during this interval.
• •10. Willing and able to comply with required scheduled visits and study procedures.