drugset / Trial / NCT06597513

Auto-HSCT-Supported Dose-Dense Chemotherapy with Adebrelimab As First-Line Treatment for ES-SCLC

NCT06597513

Phase 1/2 Not yet recruiting 10 enrolled Zhou Chengzhi
NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to learn if hematopoietic stem cell transplantation-supported dose-dense chemotherepy with adebrelimb works to treat extensive-stage small-cell lung cancer in adults. It will also assess the safety of this treatment approach. The main questions it aims to answer are: Does hematopoietic stem cell transplantation-supported dose-dense chemotherepy with adebrelimb improve the median progression free survival and 12-months overall survival rates? What medical problems do participants experience whild undergoing this treatment? Participants will: Complete two 21-days cycles of standard-dose etoposide and carboplatin, followed by G-CSF for stem cell mobilization. Receive dose-dense chemotherapy followed by autologous stem cell reinfusion for two 21-day cycles. If eligible, participants will receive etoposide and carboplatin plus adebrelimab for four cycles. Finally, participants may enter a maintenance phase with adebrelimab. Throughout the trial, participants will: Visit the clinic every 21 days for check-ups and tests. Imaging examination every 6 weeks. Followed up by telephone every 2 months

Timeline

Start
2024-12
Primary completion
2025-12
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Adebrelimab Monoclonal antibody 1200 mg
Background Carboplatin Small molecule
Background Etoposide Small molecule 80 mg/m2
Background Etoposide Small molecule 100 mg/m2
Background Etoposide Small molecule 160 mg/m2
Background Etoposide Small molecule 200 mg/m2