Luminal Bladder Cancer Effective Response to Neoadjuvant Chemotherapy (LUMBER-NAC) (NCT07762586) | Clinical Trial Compass
RecruitingPhase 2
Luminal Bladder Cancer Effective Response to Neoadjuvant Chemotherapy (LUMBER-NAC)
United States60 participantsStarted 2026-07-10
Plain-language summary
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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ▪ Inclusion Criteria
* Willing and able to provide informed consent
* Age ≥18 years old
* Eligible to receive standard of care systemic neoadjuvant therapy
* Eastern Cooperative Group (ECOG) performance status of 0-1
* Documented histologically confirmed urothelial muscle-invasive bladder cancer
* cT2N0M0 bladder cancer based on pre-TURBT bimanual exam and cross-sectional imaging performed within 8 weeks of surgery or initiation of NAT.
* Willing to undergo RC with urinary diversion
* No signs of extravesical disease on pre-TURBT conventional imaging
* Variant histology is allowed so long as the tumor is predominantly urothelial carcinoma.
* No presence of LVI on TURBT
* Decipher Bladder GSC test result
* Ineligible for or refusing TMT
* No cN+
* The population is adult men or women of any ethnicity diagnosed with muscle-invasive bladder cancer.
Exclusion Criteria:
* Patients under 18 years old. Considering the minimal incidence of bladder cancer among the pediatric population, children are not eligible for this study.
* Not willing or unable to give informed consent.
* Clinical or pathological evidence of metastatic disease, including, non-regional lymph nodes, visceral lesions, and bone lesions.
* Significant hepatic impairment (Serum bilirubin \> 1.5x upper limit of normal).
* Significant renal impairment (creatinine clearance \<30 ml/min).
* Predominant variant histology (i.e. nested, micropapillary, sarcomatoid, plasm…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
: Pathological upstaging rate at radical cystectomy (pT3-pT4 or pN+)
Timeframe: At the time of radical cystectomy
Trial details
NCT IDNCT07762586
SponsorRutgers, The State University of New Jersey