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. 2025 Apr;21(10):1171-1177.
doi: 10.1080/14796694.2025.2480534. Epub 2025 Mar 21.

A phase II study of lurbinectedin with or without avelumab in small cell carcinoma of the bladder (laser)-design and rationale

Nicholas Simon  1 , Elias Chandran  1 , Saad Atiq  1 , Andre R Kydd  1 , Daniel Girardi  1 , Lisa Ley  1 , Lisa Cordes  1 , Tzu-Fang Wang  1 , Salah Boudjadi  1 , Ian Stukes  1 , Elizabeth Smith  1 , Dilara Akbulut  2 , Scot Niglio  3 , Ruchi Patel  1 , Rouf Banday  1 , Bernadette Redd  4 , Sandeep Gurram  5 , Seth Steinberg  6 , Andrea B Apolo  1
Affiliations

A phase II study of lurbinectedin with or without avelumab in small cell carcinoma of the bladder (laser)-design and rationale

Nicholas Simon et al. Future Oncol. 2025 Apr.

Abstract

Small cell carcinoma of the bladder is a rare, aggressive malignancy accounting for less than 1% of all bladder malignancies. Treatment regimens are drawn from the small cell lung cancer (SCLC) literature, with platinum and etoposide commonly used in the first-line setting. Unfortunately, responses are generally short-lived, and most patients relapse. There is little evidence to guide selection of later lines of therapy. Lurbinectedin is an alkylating agent with accelerated US FDA approval for use in patients with SCLC. Immune checkpoint inhibitors have also been approved for SCLC, improving survival when added to chemotherapy. This article describes the design and rationale behind LASER, an open-label phase II trial of lurbinectedin with or without avelumab.Clinical trial registration: NCT06228066 (ClinicalTrial.gov).

Keywords: Small cell bladder cancer; avelumab; bladder cancer; high-grade neuroendocrine carcinoma; lurbinectedin.

Plain language summary

Small cell carcinoma of the bladder is a rare and aggressive cancer. Unfortunately, there are few treatment options. Clinical trials do not usually focus on these types of rare cancers. Treatments are borrowed from more common cancers that are similar, for example, small cell lung cancer. Lurbinectedin is a drug that is used to treat patients with small cell lung cancer. Immune checkpoint inhibitors like avelumab are used to direct the immune system to fight the cancer. These drugs have shown promise in treating both small cell lung cancer and bladder cancer. We are conducting a clinical trial to understand if drugs like lurbinectedin and avelumab will work for small cell bladder cancer patients. We are looking to see if the drugs are able to stop tumors from growing and allow patients to live longer.

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Conflict of interest statement

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

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