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

Study acronym: LUXUS41
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Phase changed: Phase 2 → Phase 3 Show 4 more changesShow less
    • Recruitment opened
    • Interventions: Disitamab Vedotin (RC48) (Drug), Gemcitabine (1000 mg/m2) (Drug), carboplatin (Drug), radiotherapy (Radiation) to Disitamab Vedotin (RC48) (Drug), Gemcitabine (1000 mg/m2) (Drug), carboplatin (Drug), radiotherapy (Radiation)
    • Eligibility criteria expanded, about 14 words
    • Site details revised
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This randomized, open-label, multicenter phase III 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
(from sponsor)		 Upper Tract Urothelial Carcinoma
Enrollment 192 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov