NCT06475209

Adebrelimab + Apatinib in SCLC Maintenance Therapy

Observational Study on the Efficacy and Safety of Adebrelimab Combined With Apatinib in Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Tang-Du Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This prospective clinical study aims to evaluate and observe the efficacy and safety of Atezolizumab combined with Apatinib in maintenance therapy for extensive-stage small cell lung cancer using a single-arm trial design. The study is planned to be conducted in Shaanxi Province, China, with an initial target enrollment of 60 patients. The study commenced in February 2024, and recruitment is expected to conclude around December 2025, with the trial anticipated to end by December 2026. Assuming no occurrences such as withdrawal of informed consent by subjects, intolerable adverse drug reactions, or investigator-assessed unsuitability for further participation, each participant's estimated duration of study treatment will continue until radiographically confirmed tumor progression.

Conditions

• SCLC

Interventions

Type	Name	Description
DRUG	Adebrelimab combined with Apatinib	Each treatment cycle spans 3 weeks. Sequential medication administration begins on the first day of each cycle: Atezolizumab is administered at a dosage of 1200mg on day 1, every 3 weeks, while Apatinib is given orally at a dosage of 250mg daily from day 1 to day 14, every 3 weeks, with a one-week hiatus following two weeks of continuous intake. Administration timing allows for a window of ±5 days. Subjects are required to undergo comprehensive assessments, including vital signs monitoring, anthropometric measurements, physical examinations, laboratory analyses, and performance status evaluations, to assess treatment tolerability for continuation.

Timeline

• Start date: 2024-06-20
• Primary completion: 2025-12-20
• Completion: 2026-12-20
• First posted: 2024-06-26
• Last updated: 2024-06-26

Locations

1 site across 1 country: China