Phase III study in first-line treatment of patients with metastatic colorectal cancer who are not candidate for intensive therapy. (SOLSTICE)

Prior treatment

• Participation in another interventional study within 4 weeks prior to the randomisation .
• Patients who have not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy prior to the randomisation.
• Major surgery within 4 weeks prior to the randomisation.

Other

• Pregnancy, breastfeeding or possibility of becoming pregnant during the study.
• Symptomatic central nervous system metastases.
• Any contraindication present in the SmPC of trifluridine/tipiracil

• Has definitive histologically confirmed adenocarcinoma of the colon or rectum (all other histological types are excluded). Primary tumour localisation must be known.
• RAS status based on local biological assessment of tumour biopsy must be available. If RAS status is not available at the time of randomisation, tumour biopsy must be available for RAS status determination (based on local biological assessment).
• Patient is not a candidate for standard full dose combination chemotherapy with irinotecan or oxaliplatin
• Patient is not a candidate for curative resection of metastatic lesions
• No previous systemic anticancer therapy for unresectable metastatic colorectal cancer
• ECOG (Eastern Cooperative Oncology Group) performance status ≤2.
• Adequate organ function (renal, haematological, hepatic, coagulation) as described in the study protocol'