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Addition of Thoracic Consolidation Radiotherapy to the Maintenance Immunotherapy for ES-SCLC (STONE-001)
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.
Details
| Lead sponsor | Anhui Shi, MD |
|---|---|
| Phase | PHASE3 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 182 |
| Start date | Mon Dec 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Sat Dec 16 2028 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Extensive-stage Small Cell Lung Cancer
Interventions
- High-dose Hyperfractionated Simultaneous Integrated Boost Radiotherapy
- atezolizumab or durvalumab