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Clinical Trial NCT07498907 (LUXUS41) for Upper Tract Urothelial Carcinoma is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Disitamab Vedotin Plus Radiotherapy for Adjuvant Treatment of HER2-Expressing Cisplatin-Ineligible Upper Tract Urothelial Carcinoma (LUXUS41) Phase 2 192 Randomized Open-Label Overall Survival
Clinical Trial NCT07498907 (LUXUS41) is designed to study Treatment for Upper Tract Urothelial Carcinoma. This Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on 1 May 2026 until the study accrues 192 participants. Led by Peking University First Hospital, this study is expected to complete by 1 March 2034. The latest data from ClinicalTrials.gov was last updated on 27 March 2026.
Brief 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+, ...Show More
Official Title
A Randomized, Prospective, Multicenter, Phase II Study of Disitamab Vedotin Plus Radiotherapy as Adjuvant Treatment for HER2-Expressing Cisplatin-Ineligible Upper Tract Urothelial Carcinoma
Conditions
Upper Tract Urothelial CarcinomaOther Study IDs
- LUXUS41
- LUXUS4.1
NCT ID Number
Start Date (Actual)
2026-05-01
Last Update Posted
2026-03-27
Completion Date (Estimated)
2034-03-01
Enrollment (Estimated)
192
Study Type
Interventional
PHASE
Phase 2
Status
Not yet recruiting
Keywords
UTUC
HER2
Disitamab Vedotin
Radiotherapy
Adjuvant Therapy
Cisplatin-Ineligible
Upper Tract Urothelial Carcinoma
HER2
Disitamab Vedotin
Radiotherapy
Adjuvant Therapy
Cisplatin-Ineligible
Upper Tract Urothelial Carcinoma
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalDisitamab Vedotin Plus Radiotherapy Participants in this arm will receive disitamab vedotin plus radiotherapy as adjuvant treatment after radical surgery for HER2-expressing,cisplatin-ineligible upper tract urothelial carcinoma. | Disitamab Vedotin (RC48) Disitamab vedotin 2.0 mg/kg (maximum 120 mg) will be administered intravenously every 2 weeks for 12 cycles as adjuvant treatment after radical surgery. Radiotherapy Adjuvant radiotherapy will be delivered to the regional lymphatic drainage area at 45-50 Gy in 25 fractions over 5 weeks. Suspicious lymph nodes will receive 62.5 Gy in 25 fractions over 5 weeks. |
Active ComparatorGemcitabine Plus Carboplatin Participants in this arm will receive gemcitabine plus carboplatin as adjuvant treatment after radical surgery for HER2-expressing cisplatin-ineligible upper tract urothelial carcinoma. | Gemcitabine (1000 mg/m2) Gemcitabine 1000 mg/m² will be administered on Days 1 and 8 of each 21-day cycle for 4 to 6 cycles as adjuvant treatment after radical surgery. carboplatin Carboplatin will be administered intravenously on Day 1 of each 21-day cycle at a target AUC of 4.5 to 5 for 4 to 6 cycles as adjuvant treatment after radical surgery. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
3-Year Disease-Free Survival | Disease-free survival (DFS) is defined as the time from randomization to first recurrence in the tumor bed, first metastasis, or death from any cause, whichever occurs first. | From randomization up to 3 years |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Overall Survival | Overall survival (OS) is defined as the time from randomization to death from any cause. | From randomization up to 3 years |
Metastasis-Free Survival | Metastasis-free survival (MFS) is defined as the time from randomization to first documented distant metastasis or death from any cause, whichever occurs first. | From randomization up to 3 years |
Local Recurrence-Free Survival | Local recurrence-free survival (LRFS) is defined as the time from randomization to first documented locoregional recurrence in the tumor bed or regional lymph nodes, or death from any cause, whichever occurs first. | From randomization up to 3 years |
Bladder Recurrence-Free Survival | Bladder recurrence-free survival (BRFS) is defined as the time from randomization to first documented bladder urothelial recurrence or death from any cause, whichever occurs first | From randomization up to 3 years |
Incidence of Adverse Events | Safety will be evaluated based on the incidence, type, severity, and attribution of adverse events during study treatment and follow-up. | From first dose through 30 days after completion of study treatment and up to 3 years for follow-up |
Patient-Reported Quality of Life | Patient-reported quality of life will be assessed using validated quality-of-life questionnaires during treatment and follow-up. | Baseline through 3 years |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Aged 18 years or older.
- Histologically confirmed upper tract urothelial carcinoma (UTUC) after radical nephroureterectomy (RNU).
- Postoperative pathologic stage pT3-pT4N0M0 or pTanyN+M0.
- HER2 expression confirmed by immunohistochemistry (IHC 1+, 2+, or 3+).
- Cisplatin-ineligible, defined as meeting at least one of the following criteria: ECOG performance status 2; creatinine clearance <60 mL/min; CTCAE grade 2 or higher hearing loss; CTCAE grade 2 or higher peripheral neuropathy; or New York Heart Association (NYHA) class III heart failure.
- Adequate organ function.
- Expected survival of at least 6 months.
- History of other active malignancies, except for adequately treated malignancies with low risk of recurrence.
- Prior systemic antitumor therapy before study treatment, or unresolved toxicities from prior therapy.
- Known hypersensitivity to disitamab vedotin, related agents, or any component of the study treatment.
- Severe active infection.
- Not adequately recovered from surgery.
- Pregnant or breastfeeding women.
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.
Peking University First HospitalRemeGen Co., Ltd.Study Central Contact
Contact: Xuesong Li, Dr., 010-83572418, [email protected]
Contact: Zihao Tao, Dr., [email protected]
1 Study Locations in 1 Countries
Peking University First Hospital, Beijing, China
Xuesong Li, Dr., Contact, 010-83572418, [email protected]
Qi Tang, Dr., Contact, [email protected]