NCT06177925

A Phase Ⅱ Clinical Study of Adebrelimab Combined With Chemotherapy and Concurrent Radiotherapy for Extensive-Stage Oligometastatic SCLC

A Phase Ⅱ Exploratory Clinical Study of Adebrelimab Combined With Chemotherapy and Concurrent Radiotherapy as First-Line Treatment for Extensive-Stage Oligometastatic Small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single arm Phase II study designed to evaluate the efficacy and safety of adebelizumab combined with carboplatin/Cisplatin plus (+) etoposide and concurrent radiotherapy in the first-line treatment of patients with extensive stage oligometastatic small cell lung cancer.

Detailed description

Participants will receive Adebrelimab intravenously in combination with carboplatin /Cisplatin and etoposide during the induction phase (2 Cycles ). Thereafter, participants will receive concurrent chemoradiotherapy(thoracic radiation therapy and SBRT for metastases,combination with carboplatin /Cisplatin and etoposide for 1-2 Cycles).Then participants will receive Adebrelimab combination with carboplatin /Cisplatin and etoposide for 1-2 Cycles,followed by Adebrelimab maintenance until persistent radiographic PD, intolerable toxicity or withdrawal of consent during the maintenance phase.

Conditions

• Respiratory Tract Neoplasms
• Thoracic Neoplasms
• Neoplasms by Site
• Neoplasms
• Lung Diseases
• Respiratory Tract Diseases
• Carcinoma, Bronchogenic
• Bronchial Neoplasms
• Lung Neoplasms
• Small Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	Adebrelimab	Adebrelimab intravenous infusion will be administered during the induction phase (Cycles 1-2 ) and maintenance phase.
DRUG	Carboplatin/Cisplatin	Carboplatin/Cisplatin intravenous infusion will be administered during the induction phase, concurrent chemoradiotherapy phase and maintenance phase(Cycles 1-4 or 6).
DRUG	Etoposide	Etoposide intravenous infusion will be administered during the induction phase, concurrent chemoradiotherapy phase and maintenance phase(Cycles 1-4 or 6).
RADIATION	Radiation therapy	IMRT for thoracic of 45--55Gy in 15-22 fractions，SBRT for metastases during the concurrent chemoradiotherapy phase

Timeline

• Start date: 2023-12-10
• Primary completion: 2026-06-30
• Completion: 2026-09-30
• First posted: 2023-12-20
• Last updated: 2023-12-20

Locations

1 site across 1 country: China