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NCT Number: NCT07498907

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

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.

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Key information

Conditions

Upper Tract Urothelial Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Disitamab Vedotin (RC48)

Drug

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

Radiation

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.

Gemcitabine (1000 mg/m2)

Drug

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

Drug

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 outcomes

  1. 3-Year Disease-Free Survival

    Time frame: From randomization up to 3 years

    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.

Secondary outcomes

  1. Overall Survival

    Time frame: From randomization up to 3 years

    Overall survival (OS) is defined as the time from randomization to death from any cause.

  2. Metastasis-Free Survival

    Time frame: From randomization up to 3 years

    Metastasis-free survival (MFS) is defined as the time from randomization to first documented distant metastasis or death from any cause, whichever occurs first.

  3. Local Recurrence-Free Survival

    Time frame: From randomization up to 3 years

    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.

  4. Bladder Recurrence-Free Survival

    Time frame: From randomization up to 3 years

    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

  5. Incidence of Adverse Events

    Time frame: From first dose through 30 days after completion of study treatment and up to 3 years for follow-up

    Safety will be evaluated based on the incidence, type, severity, and attribution of adverse events during study treatment and follow-up.

  6. Patient-Reported Quality of Life

    Time frame: Baseline through 3 years

    Patient-reported quality of life will be assessed using validated quality-of-life questionnaires during treatment and follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Xuesong Li, Dr.

CONTACT

[email protected]

010-83572418

Zihao Tao, Dr.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Collaborators

  • RemeGen Co., Ltd.

Registry information

Official study 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

Acronym: LUXUS41

Important dates

Study start
2026
Primary completion
2029
Study completion
2034
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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