Clinical Trial

Disitamab Vedotin Plus Radiotherapy for Adjuvant Treatment of HER2-Expressing Cisplatin-Ineligible Upper Tract Urothelial Carcinoma

Study acronym: LUXUS41
Not Yet Recruiting Phase 2
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Summary
This randomized, open-label, multicenter phase II study is designed to compare disitamab vedotin plus radiotherapy with gemcitabine plus carboplatin as adjuvant treatment in patients with HER2-expressing upper tract urothelial carcinoma after radical nephroureterectomy (RNU). Eligible patients must have postoperative pathologic stage pT3-pT4N0M0 or pTanyN+M0, HER2 expression defined as immunohistochemistry (IHC) 1+, 2+, or 3+, and be cisplatin-ineligible. Patients will be randomized in a 2:1 ratio to receive disitamab vedotin plus radiotherapy or gemcitabine plus carboplatin. The primary endpoint is 3-year disease-free survival. Secondary endpoints include overall survival, metastasis-free survival, local recurrence-free survival, bladder recurrence-free survival, incidence of adverse events, and patient-reported quality of life.
Trial Details
NCT Number NCT07498907
Lead Sponsor Peking University First Hospital
Collaborators: RemeGen Co., Ltd.
Conditions Upper Tract Urothelial Carcinoma
Enrollment 192 participants
Start Date 2026-05-01
Primary Completion 2029-05-01 (estimated)
Study Completion 2034-03-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-27