A phase II, open-label, randomized, multi-center study comparing the efficacy and safety of Sacituzumab govitecan versus investigator's choice in patients with cancer of unknown primary (CUP) who are relapsed after or refractory to platinum-based chemotherapy (SACICUP)

Neoplasm

Progression-free survival (PFS), defined as thetime from randomization to the first occurrence ofdisease progression, as assessed by theinvestigator according to Response EvaluationCriteria in Solid Tumors, Version 1.1 (RECISTv1.1), or death from any cause, whichever occursfirst.

Overall survival (OS), defined as the time fromrandomization to death from any cause, Overall response rate (ORR), defined as theproportion of participants who exhibit a CR or PRto study treatment on two consecutive occasions≥ 4 weeks apart., Duration of clinical benefit (DCB), defined as thetime from the first occurrence of a CR, PR or SDafter treatment start until disease progression ordeath from any cause, whichever occurs first., Incidence, nature and severity of adverse events(AEs), Incidence and reasons for any interruptions, orpremature discontinuation of any component ofstudy treatment, Clinically significant laboratory values and vitalsigns, Quality of life under treatment with EORTC QLQ-C30, Patient-reported side effects with PRO CTCAE items (shortened version)

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