Lonsurf: This phase III trial is evaluating anti-cancer drugs Trifluridine and Tipiracil in patients who have previously received treatment for metastatic colorectal cancerAn open-label early access phase IIIb study of trifluridine / tipiracil (S 95005/TAS-102) in patients with a pretreated metastatic colorectal cancer

Inclusion

• Male or Female participant aged ≥18 years old.
• Has definitive histologically confirmed adenocarcinoma of the colon or rectum.
• Has metastatic lesion(s).
• Has received at least 2 prior regimens of standard chemotherapies (including fluoropyrimidines, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody and at least one of the anti-EGFR monoclonal antibodies for RAS wild-type patients) for mCRC and is refractory or intolerant to those chemotherapies or is not candidate for those chemotherapies.
• Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 during the screening period.
• Is able to take medications orally (i.e., no feeding tube).
• Has adequate organ function.
• Women of childbearing potential must have been tested negative in a serum pregnancy test within 7 days prior to first day of test drug administration. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use a highly effective method of birth control during the study and for 6 months after the discontinuation of study medication. Women and female partners using hormonal contraceptive must also use a barrier method.