NCT06483282

A Study of Adebrelimab Combined With Apatinib Mesylate and Chemotherapy for Neoadjuvant Therapy and Biomarker Analysis in Limited-stage Small Cell Lung Cancer

A Single-arm, Prospective, Exploratory Study of Adebrelimab Combined With Apatinib Mesylate and Chemotherapy for Neoadjuvant Therapy and Biomarker Analysis in Limited-stage Small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Jin Ying · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, prospective, exploratory phase II clinical study. The study enrolled newly diagnosed stage T1-3N0-1M0 resectable limited-stage small cell lung cancer. Adebrelimab combined with chemotherapy for 4 cycles and apatinib mesylate for 3 cycles. Surgery was performed within 4-8 weeks after the above treatment (the operation was performed 4 weeks after apatinib was discontinued). According to the results of MDT discussion, adebrelimab combined with apatinib mesylate combined with or without radiotherapy was started 4 weeks after surgery. Preoperative prophylactic radiotherapy (PCI) is recommended for patients with preoperative stage N1. Patients with postoperative stage N1 received postoperative thoracic radiotherapy.

Detailed description

Preoperative prophylactic radiotherapy (PCI) is recommended for patients with preoperative stage N1. Patients with postoperative stage N1 received postoperative thoracic radiotherapy.

Conditions

• Small Cell Lung Cancer Limited Stage

Interventions

Type	Name	Description
DRUG	Adebrelimab	This product is administered by intravenously guttae. The recommended dose of subcutaneous injection is 20mg/kg, administered every 3 Weeks (Q3W).
DRUG	Apatinib Mesylate	This product is an orally administered targeted therapy drug, with a recommended dosage of one tablet per day.
DRUG	Etoposide	This product is administered by intravenously guttae. The recommended dose of subcutaneous injection is 100mg/m2, administered every 3 Weeks (Q3W).
DRUG	Carboplatin	This product is administered by intravenously guttae. AUC=5, administered every 3 Weeks (Q3W).

Timeline

• Start date: 2024-06-21
• Primary completion: 2026-06-01
• Completion: 2026-12-31
• First posted: 2024-07-03
• Last updated: 2025-04-15

Locations

1 site across 1 country: China