NCT07200154

Adebrelimab Plus Chemoradiotherapy Followed by Adebrelimab Maintenance in Limited-Stage SCLC

A Single-arm、Exploratory Study of Adebrelimab in Combination With Chemoradiotherapy Followed by Adebrelimab Maintenance in Patients With Limited-stage Small-cell Lung Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label, single-center phase II trial that will enroll 30 patients with limited-stage small-cell lung cancer to evaluate the safety and efficacy of adebrelimab combined with chemoradiotherapy followed by adebrelimab maintenance.

Detailed description

This investigator-initiated trial will be conducted in the Department of Radiation Oncology, Peking University Cancer Hospital. Thirty patients with limited-stage small-cell lung cancer (LS-SCLC) will be enrolled in this pilot study to explore whether the addition of adebrelimab to chemoradiotherapy can improve outcomes for this population. Eligible participants will receive adebrelimab combined with chemoradiotherapy（etoposide plus platinum). Patients who achieve complete or partial response will undergo prophylactic cranial irradiation (PCI) within 1-30 days after completion of chemoradiotherapy, followed by adebrelimab monotherapy (1200 mg intravenously every 3 weeks) as consolidation and maintenance for up to 24 months in the absence of progression or unacceptable toxicity. Treatment will be discontinued if the patient develops progressive disease, experiences unacceptable drug-related toxicity, withdraws consent, or meets any other pre-specified withdrawal criterion. Both efficacy (objective response rate, progression-free survival, overall survival) and safety (adverse events graded by CTCAE v5.0) endpoints will be assessed throughout the study.

Conditions

• Limited-stage Small-cell Lung Cancer
• Concurrent Chemoradiation Therapy

Interventions

Type	Name	Description
DRUG	Adebrelimab with concurrent chemoradiotherapy	Adebrelimab combined with chemotherapy and concurrent radiotherapy, followed by maintenance therapy with Adebrelimab until disease progression or intolerable toxicity, for up to 2 years.

Timeline

• Start date: 2025-09-30
• Primary completion: 2028-03-30
• Completion: 2028-09-01
• First posted: 2025-09-30
• Last updated: 2025-09-30

Locations

1 site across 1 country: China