NCT06768307

Assessment of Adebelizumab Combined with Chemotherapy in Concurrent Radiotherapy Versus Sequential Radiotherapy As First-Line Treatment for Extensive-Stage Small Cell Lung Cancer

Exploratory Clinical Study of Adebrelimab Combined with Chemotherapy and Concurrent Radiotherapy Versus Sequential Radiotherapy As First-Line Treatment for Extensive-Stage Small Cell Lung Cancer（ES-SCLC）.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Immunotherapy combined with chemotherapy has emerged as the standard of care for patients with extensive-stage small cell lung cancer (ES-SCLC). The incorporation of thoracic radiotherapy can enhance treatment efficacy. Currently, the main types of research investigating immunotherapy combined with thoracic radiotherapy for untreated ES-SCLC are concurrent radiotherapy and sequential radiotherapy. The aim of this study is to evaluate the efficacy of adebelizumab in combination with chemotherapy, when administered concurrently with radiotherapy versus sequentially with radiotherapy, as a first-line treatment for ES-SCLC.

Conditions

• SCLC, Extensive Stage
• Immunotherapy
• Chemotherapy
• Radiotherapy

Interventions

Type	Name	Description
DRUG	First-line Immunotherapy Combined with Chemoradiotherapy for ES-SCLC	Cohort 1: Induction Phase: Patients will receive three cycles of atezolizumab in combination with carboplatin/cisplatin plus etoposide. Concurrent Radiotherapy Phase: the fourth cycle will incorporate concurrent radiotherapy along with atezolizumab and chemotherapy. Maintenance Phase: Atezolizumab monotherapy will be administered until disease progression or intolerance by the patient, with atezolizumab being administered for a maximum duration of 2 years. Cohort 2: Induction Phase: Patients will receive three cycles of atezolizumab in combination with carboplatin/cisplatin plus etoposide. Sequential Radiotherapy Phase: the fourth cycle will receive sequential radiotherapy in combination with atezolizumab.Final，Atezolizumab monotherapy will be continued until disease progression.

Timeline

• Start date: 2025-02-01
• Primary completion: 2027-01-01
• Completion: 2028-01-01
• First posted: 2025-01-10
• Last updated: 2025-01-10

Locations

1 site across 1 country: China