Phase II Study of Durvalumab with Carboplatin and Etoposide Followed by Durvalumab Maintenance in Adults with Metastatic Pulmonary Large-cell Neuroendocrine Carcinoma

What this Trial Is About

Researchers are evaluating a treatment approach for patients with metastatic pulmonary large-cell neuroendocrine carcinoma LCNEC who have not received prior therapy. This prospective multicenter phase II study aims to assess the combination of durvalumab with carboplatin and etoposide chemotherapy as a first-line treatment in this population. Participants will receive an induction phase of intravenous durvalumab 1500 mg on day 1, carboplatin AUC 5 on day 1, and etoposide 100 mgsqm on days 1-3 every three weeks for up to 4 cycles or until disease progression, unacceptable side effects, or other stopping reasons. Following this, patients enter a maintenance phase receiving durvalumab 1500 mg intravenously every 4 weeks for up to 24 additional courses, totaling 28 courses or 2 years of treatment, whichever comes first. Throughout the study, participants will undergo regular clinical assessments to monitor treatment effects, side effects, and disease status. Researchers will measure treatment efficacy using established criteria over one year. Safety and tolerability will also be closely tracked. The total duration of participant involvement may last up to 2 years or until disease progression or intolerable toxicity occurs.

Durvalumab With Carboplatin and Etoposide Chemotherapy in Pulmonary Large-cell Neuroendocrine Carcinoma (LCNEC)