NCT06719336

Addition of Thoracic Consolidation Radiotherapy to the Maintenance Immunotherapy for ES-SCLC (STONE-001)

Addition of High-dose Hyperfractionated Simultaneous Integrated Boost Radiotherapy to the Maintenance Therapy with PD-L1 Inhibitor Versus PD-L1 Inhibitor Alone for Extensive Stage Small Cell Lung Cancer (STONE-001)

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 182 (estimated)
• Sponsor: Anhui Shi, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is expected to enroll 182 patients with partial response or stable disease after first-line immunochemotherapy for extensive-stage small cell lung cancer and eligible for thoracic consolidation radiotherapy within 2 years. Patients were randomized 2:1 to immune single-agent maintenance therapy in combination with hyperfractionated high-dose radiotherapy and immune single-agent maintenance therapy after being assessed by the investigator as otherwise eligible for enrollment. Patients in both arms received maintenance therapy with the PD-L1 inhibitor, atezolizumab or dulvedolizumab, until disease progression, unacceptable toxicity, or loss of clinical benefit. Patients in the combined radiotherapy arm required hyperfractionated high-dose (54 Gy) radiotherapy twice daily for residual disease in the chest. Each patient will be followed for approximately 2 years.

Conditions

• Extensive-stage Small Cell Lung Cancer

Interventions

Type	Name	Description
RADIATION	High-dose Hyperfractionated Simultaneous Integrated Boost Radiotherapy	Twice-daily thoracic radiotherapy at a dose of 54 Gy in 30 fractions with IMRT and VMAT
DRUG	atezolizumab or durvalumab	atezolizumab 1200 mg Q3W or durvalumab 1500 mg Q4W

Timeline

• Start date: 2024-12-16
• Primary completion: 2028-12-16
• Completion: 2028-12-16
• First posted: 2024-12-05
• Last updated: 2024-12-05