Luminal Bladder Cancer Effective Response to Neoadjuvant Chemotherapy (LUMBER-NAC)

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor: Rutgers, The State University of New Jersey
Study ID: NCT07762586
Phase: PHASE2
Status: Recruiting

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Conditions

Bladder Cancer

Eligibility Criteria

Sex: ALL
Age: 18 Years - 90 Years
Healthy Volunteers: Not accepted

Interventions

Neoadjuvant Therapy — DRUG
Patients will undergo standard of care neoadjuvant therapy followed by radical cystectomy
Upfront radical cystectomy — PROCEDURE
Patients will undergo upfront radical cystectomy without neoadjuvant therapy

Study Details

This study is a two-arm phase II randomized trial investigating patients with luminal subtype muscle-invasive bladder cancer (MIBC) receiving neoadjuvant therapy (NAT) followed by cystectomy compared to those receiving upfront cystectomy.

Key Dates

First listed: Aug 13, 2026
Start date: Jul 10, 2026
Status verified: Aug 2026
Primary completion: Jul 31, 2027
Completion: Jul 31, 2029

Study Design

Enrollment: 60 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Active Comparator: Neoadjuvant Systemic Therapy Followed by Radical Cystectomy
Participants receive standard-of-care neoadjuvant systemic therapy, as selected by the treating physician, followed by radical cystectomy with urinary diversion. Interventions: Each specific drug regimen confirmed by the PI, plus Radical Cystectomy With Urinary Diversion.
Experimental: Upfront Radical Cystectomy
Participants proceed directly to radical cystectomy with urinary diversion without receiving initial neoadjuvant systemic therapy. Intervention: Radical Cystectomy With Urinary Diversion