Clinical Trial

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

Not Yet Recruiting Phase 3
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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.
Trial Details
NCT Number NCT06719336
Lead Sponsor Anhui Shi, MD
Conditions Extensive-stage Small Cell Lung Cancer
Enrollment 182 participants
Start Date 2024-12-16
Primary Completion 2028-12-16 (estimated)
Study Completion 2028-12-16 (estimated)
Updated on ClinicalTrials.gov 2024-12-05