Agnostic phase II, multicenter, single-arm study with DURVAlumab plus carboplatin or cisplatin and etoposide as first-line treatment in extensive stage - Extrapulmonary Small Cell Carcinoma (EPSCC) patients - DURVASCC trial (GOIRC-01-2021).

ABSTRACT:

Background

EPSCCs represent rare and extremely aggressive tumors. In most cases, with widespread metastatic disease, the incidence rate is between 0.1% and 0.4%, and the median survival of less than one year. At present, chemotherapy is considered the only therapeutic strategy in the extensive stage of EPSCC.

Methods/design

This is an open-label, multicenter, Italian phase II single-arm trial in which patients with extensive-stage EPSCC will receive first-line therapy with intravenously durvalumab (day 1) plus carboplatin or cisplatin, and etoposide (day 1-3) every 3 weeks for 4 or 6 cycles, as investigator's choice, followed by maintenance with durvalumab every 4 weeks for a maximum of 24 months. Durvalumab will be administered at a fixed dose of 1500 mg, cisplatin at 75 to

SUBMITTER: Damato A 

PROVIDER: S-EPMC12613450 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature