 - Previous use of systemic chemotherapy or other investigational drugs for the treatment of inoperable locally recurrent or metastatic tumors previous use of radiotherapy in this setting is not an exclusion criterion if: 1 non-irradiated target tumor lesions are present at randomization for the purpose of tumor response assessment or 2 in the absence of non-irradiated target tumor lesions, progression of the irradiated tumor lesions according to the RECIST criteria version 1.1 is documented 