Phase IbII Study of LBL-024 With Etoposide and Platinum as First Treatment for Advanced Neuroendocrine Carcinoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a combination treatment using LBL-024 with etoposide and platinum drugs in people with advanced neuroendocrine carcinoma NEC. This study is an open-label, multicenter phase IbII trial designed to explore new treatment options for patients who have not received prior systemic therapy for NEC. The study aims to carefully assess how well patients respond to this combination and to find the best dose for further use. The trial has two parts phase Ib focuses on finding a safe and tolerable dose of LBL-024 combined with etoposide and platinum cisplatin or carboplatin using a dose-escalation method. Phase II then optimizes the dose and expands the study to more patients to confirm the recommended dose for future research. Participants are randomly assigned to receive either LBL-024 with etoposide and carboplatincisplatin or a comparator group receiving atezolizumab with etoposide and carboplatin. All treatments are given by intravenous infusion. Participants will undergo regular assessments including tumor measurements according to RECIST 1.1 criteria, monitoring of drug levels and immune responses, and tracking any side effects or serious events. The main outcomes measured include objective response rate, progression-free survival, dose-limiting toxicities, and safety events over a follow-up period after treatment ends. The study plans to enroll 178 patients aged 18 to 75 years and will continue through March 2027, with careful safety monitoring throughout.

A Clinical Trial of LBL-024 Combined With Etoposide and Platinum in Patients With Advanced Neuroendocrine Carcinoma