OncoMatch/Clinical Trials/NCT06228066
Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER)
Is NCT06228066 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Lurbinectedin and Avelumab for small cell carcinoma of the bladder.
Treatment: Lurbinectedin · Avelumab — Background: Small cell carcinoma of the bladder (SCCB) and other high-grade neuroendocrine tumors (HGNET) of the urinary tract are rare but aggressive cancers. Average survival for people diagnosed with SCCB or HGNET is about 1 year. Lurbinectedin and avelumab are drugs that are approved to treat other cancers. Researchers want to see if these drugs can help people with SCCB or HGNET. Objective: To test lurbinectedin with or without avelumab in people with SCCB or HGNET. Eligibility: Adults aged 18 years and older with SCBB or HGNET that returned and spread after treatment. Design: Participants will be screened. They will have a physical exam. They will have blood tests and imaging scans. They may need to have a new biopsy: A small needle will be used to collect a tissue sample from the tumor. Both study drugs are given through a tube attached to a needle inserted into a vein. If participants have already received a drug like avelumab they will receive only lurbinectedin. If patients have not been previously treated with a drug like avelumab they will receive both lurbinectedin and avelumab. All participants will receive their treatment once every 3 weeks for up to 10 years. They will also receive other drugs to relieve adverse effects. Biopsies, blood tests, and imaging scans will be repeated during some study visits. Participants may also have urine tests and tests of their heart function. Participants may remain in the study as long as the treatment is helping them. If they stop treatment, they will have safety visits 14, 30, and 90 days after their last dose. Additional follow-up visits will continue 5 to 10 years.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroendocrine Tumor
Disease stage
Metastatic disease required
Grade: high grade
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: immune checkpoint inhibitor (PD-1 inhibitor, PD-L1 inhibitor) — Cohort 1: must have received prior ICIs (PD-1 or PD-L1) or be ineligible for treatment with ICIs; Cohort 2: must be ICI naive but eligible to receive them
For Cohort 1: Participants must have received prior ICIs (PD-1 or PD-L1) or be ineligible for treatment with ICIs. For Cohort 2: Participants must be ICI naive but eligible to receive them.
Must have received: platinum-based chemotherapy (platinum, etoposide) — must have received, be ineligible, or refused prior platinum/etoposide chemotherapy
Participants must have received, be ineligible, or refused prior platinum/etoposide chemotherapy for SCCB or other HGNET of the urinary tract.
Cannot have received: lurbinectedin (lurbinectedin)
Participants previously treated with lurbinectedin.
Cannot have received: investigational drug, chemotherapy, immunotherapy, or any prior radiotherapy (except for palliative bone directed therapy) within the past 14 days
Exception: FDA-approved hormonal therapy for the treatment or prevention of other malignancies may be continued where in the opinion of the investigator stopping such therapies may increase the risk of disease progression.
Prior investigational drug, chemotherapy, immunotherapy or any prior radiotherapy (except for palliative bone directed therapy) within the past 14 days prior to the first drug administration. Additionally, FDA-approved hormonal therapy for the treatment or prevention of other malignancies (e.g., breast cancer, prostate cancer) may be continued where in the opinion of the investigator stopping such therapies may increase the risk of disease progression.
Lab requirements
Blood counts
ANC >=1,500/microliter; Platelets >=100,000/microliter; Hemoglobin >9g/dL (erythrocyte transfusions allowed)
Kidney function
Creatinine clearance (CrCl) >= 30 mL/min/1.73 m^2 (or GFR per institutional standard)
Liver function
Total bilirubin within normal limits (exceptions: tumor involving liver or Gilbert disease <=1.5x ULN); AST/ALT <=1.5x ULN (<=5x ULN if liver involvement); CPK <=2.5x ULN
Adequate organ and marrow function as defined below: Absolute neutrophil count (ANC) >=1,500/microliter; Platelets >=100,000/ microliter; Hemoglobin (Hgb) > 9g/dL (erythrocyte transfusions are allowed to achieve acceptable Hgb); Total bilirubin within normal limits with the following exceptions: Participants with tumor involving the liver may have mild to moderate hepatic impairment with total bilirubin <= 1.5 x upper limit of normal (ULN); Participants with known Gilbert disease who have serum bilirubin level <= 1.5 x ULN; Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) <=1.5 x institutional ULN; Participants with tumor involving the liver with AST and ALT <= 5.0 x ULN and bilirubin <= 1.5 x ULN may be eligible. Creatinine clearance (CrCl) >= 30 mL/min/1.73 m^2 (glomerular filtration rate [GFR] may be used in place of CrCl. Creatinine clearance or eGFR should be calculated per institutional standard); Creatine phosphokinase (CPK) <= 2.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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