RegoNivo vs Standard of Care Chemotherapy in AGOC

Inclusion criteria

• . Adults (18 years or over) with metastatic or locally recurrent gastro-oesophageal cancer which:
• . has arisen in any primary gastro-oesophageal site (oesophago-gastric junction (GOJ) or stomach); and
• . is of adenocarcinoma or undifferentiated carcinoma histology; and
• . is evaluable according to Response Evaluation Criteria in Solid Tumours (RECIST Version 1.1) by computed tomography (CT) scan performed within 21 days prior to randomisation. A lesion in a previously irradiated area is eligible to be considered as measurable disease as long as there is objective evidence of progression of the lesion prior to study enrolment; and
• . has failed or been intolerant to a minimum of 2 lines of prior anti-cancer therapy for recurrent/metastatic disease which must have included at least one platinum agent and one fluoropyrimidine analogue. Note: Neoadjuvant or adjuvant chemotherapy or chemoradiotherapy will be considered as first line treatment where people have relapsed or progressed within 6 months of completing treatment; Radiosensitising chemotherapy given solely for this purpose concurrent with palliative radiation will not be considered as a line of treatment. Ramucirumab monotherapy, or immunotherapy with a checkpoint inhibitor, will be considered a line of treatment.
• . HER2-positive participants must have received trastuzumab
• . Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (Appendix 1).
• . Ability to swallow oral medication.

Exclusion criteria