Phase 3 Study Comparing MHB088C Injection with Physicians Choice Treatment in Adults With Relapsed Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the effectiveness and safety of MHB088C for Injection compared with the treatment of physicians choice in adults with relapsed small cell lung cancer SCLC. This Phase 3, randomized, open-label study aims primarily to see if MHB088C can extend overall survival. Secondary goals include assessing the drugs safety, immune response, and how the body processes it. Participants are randomly assigned to one of two groups. One group receives MHB088C at a dose of 2 mgkg intravenously on Day 1 and Day 15 of a 28-day cycle, continuing until unacceptable side effects, disease progression, or withdrawal. The other group receives one of three chemotherapy drugs chosen by their doctortopotecan, irinotecan, or paclitaxelgiven according to approved dosing schedules until treatment discontinuation criteria are met. During the study, participants will undergo regular assessments including monitoring survival from randomization up to approximately five years, tumor response evaluations, progression tracking, and safety checks for adverse events. Blood samples will be collected to study drug levels and immune markers. These evaluations help researchers understand both the benefits and risks of MHB088C compared to standard treatments. The total participation may last up to five years from enrollment, covering treatment and follow-up phases.

A Study of MHB088C Injection Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer