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Adebrelimab Maintenance Therapy After Concurrent Chemoradiotherapy with Hyperfractionated Radiotherapy in Limited-Stage Small Cell Lung Cancer

NCT06784206 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-01-20

No results posted yet for this study

Summary

Small cell lung cancer (SCLC) remains a challenging disease with poor prognosis and limited treatment options despite decades of research. SCLC is an immunogenic tumor, and the use of T-cell immune checkpoint inhibitors targeting the PD-1/PD-L1 axis has shown promising antitumor activity, potentially extending patient survival. The combination of concurrent chemoradiotherapy followed by immune maintenance therapy has demonstrated significant efficacy in limited-stage SCLC. Moreover, hyperfractionated accelerated radiotherapy (HART) has been shown to improve overall survival in limited-stage SCLC compared to standard dose radiotherapy without increasing toxicity. However, there is a lack of exploration into the use of immune checkpoint inhibitors following concurrent chemoradiotherapy with HART in limited-stage SCLC.

This exploratory clinical study aims to investigate the efficacy and safety of adebrelimab maintenance treatment following concurrent chemoradiotherapy with HART in patients with limited-stage SCLC through a single-arm, open-label, prospective, single-center clinical trial.

Conditions

  • Small Cell Lung Cancer, Limited Stage
  • Hyperfractionated Accelerated Radiotherapy
  • Simultaneous Radiotherapy and Chemotherapy

Interventions

DRUG

Adebrelimab Maintenance Therapy After Concurrent Chemoradiotherapy with Hyperfractionated Radiotherapy

Chemotherapy: Etoposide will be administered intravenously at a dose of 100 mg/m² on days 1 to 3 of each cycle. Cisplatin will be given at a dose of 75 mg/m² on day 1 of each cycle. The treatment will be repeated every 3 weeks for a total of 4 cycles. Concurrent Radiotherapy: Chest radiotherapy will be initiated concurrently with the first 3 cycles of chemotherapy. The total dose of radiotherapy will be 54 Gy, delivered in 30 fractions, with 2 fractions per day. Prophylactic Cranial Irradiation (PCI): For patients who achieve a partial response (PR) or complete response (CR) after chemoradiotherapy, PCI will be administered 3 to 4 weeks after the completion of chemoradiotherapy. The dose for PCI will be 25 Gy in 10 fractions. Adebrelimab Maintenance Therapy: Following PCI, patients will receive maintenance therapy with Adebrelimab. The dose will be 1200 mg administered intravenously on day 1 of each cycle. The treatment will be repeated every 3 weeks until disease progression, death

Sponsors & Collaborators

  • Peking University Cancer Hospital & Institute

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-28
Primary Completion
2026-08-31
Completion
2028-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06784206 on ClinicalTrials.gov