NCT06597513

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

A Single-Arm Trial of Hematopoietic Stem Cell Transplantation-Supported Dose-Dense Chemotherapy with Adebrelimab As First-Line Treatment for Extensive-Stage Small-Cell Lung Cancer

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Zhou Chengzhi · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Extensive Stage Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	auto-HSCT-Supported Dose-Dense Chemotherapy With Adebrelimab	Induction: Two 21-day cycles of standard-dose etoposide 80-100 mg/m² on days 1-3 and carboplatin AUC 5-6 on day 1. Those without disease progression will advance to consolidation treatment. Consolidation: Stem cell mobilization with G-CSF will be start when white blood cell count is at its nadir post-chemotherapy. After recovery, peripheral blood stem cells will be collected via apheresis, evaluated, and cryopreserved if adequate. Dose-dense etoposide 160-200 mg/m² on days 1-3 and carboplatin AUC 10-12 on day 1 for two 21-day cycles. Within 48-72 hours after the first cycle, autologous peripheral blood stem cells will be reinfused with G-CSF. Further consolidation will depend on hematopoietic recovery with standard-dose EC plus adebrelimab 1200 mg on day 1 for four 21-day cycles. Maintenance: Adebrelimab 1200 mg every 21 days will be given until disease progression, intolerable toxicity, death, patient withdrawal, or investigator decision.

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2024-09-19
• Last updated: 2024-10-15