An Open Label, Randomized, Multicenter, Phase III Study of SHR-A2102 in Combination With Adebrelimab Versus Gemcitabine in Combination With Cisplatin/Carboplatin in Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma (NEC-UC2)
The study is being conducted to evaluate the efficacy of SHR-A2102 with adebrelimab versus gemcitabine in combination with cisplatin/carboplatin in previously untreated locally advanced or metastatic urothelial carcinoma.
• Be able to sign the informed consent form in writing.
• Female or male, 18 to 80 years of age (both inclusive).
• ECOG performance status of 0 or 1.
• Expected survival of≥ 3 months.
• Histologically confirmed diagnosis of urothelial carcinoma with radiographic or other confirmation of locally advanced unresectable or metastatic disease.
• No prior systemic therapy for locally advanced or metastatic disease.
• Able to provide archived or fresh tumor tissue for Nectin-4 and PD-L1 expression.
• According to RECIST v1.1, there must be at least one measurable lesion;
• Tolerant to cisplatin or carboplatin.
⁃ Adequate organ functions.
⁃ Agree to use medically approved contraceptive measures.