In this open-label , phase @ , randomised controlled trial conducted in @ centres in @ countries , we enrolled patients aged @ years or older with histologically or cytologically confirmed HNSCC that was recurrent , metastatic , or both who had progressed on or after first-line platinum-based therapy , were not amenable for salvage surgery or radiotherapy , and who had an Eastern Cooperative Oncology Group ( ECOG ) performance status of @ or @ .