A Multicenter, Randomized, Cohort, Prospective Clinical Study of Adebrelimab Consolidation Therapy for Limited-Stage Small-Cell Lung Cancer (LS-SCLC) Without Progression After Concurrent Chemoradiotherapy
NCT07559786 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2026-04-30
Summary
This study aims to evaluate the efficacy and safety of adebrelimab consolidation therapy after progression-free response of concurrent chemoradiotherapy in patients with limited-stage small cell lung cancer. This study plans to enroll patients with untreated limited-stage small cell lung cancer who meet the inclusion criteria. The eligible patients will be randomly divided 1:1 into two groups to receive treatment regimens for residual lymph nodes and involved irradiated areas. That is, carboplatin AUC 5, D1 + etoposide 100 mg/m…\^2 on days 1, 2, and 3 + thoracic radiotherapy (residual lymph nodes or involved irradiated areas), with each 3-week cycle.After 4 cycles of concurrent chemoradiotherapy, the non-progressing subjects will continue to receive adebrelimab (1200 mg, IV, Q3W) maintenance therapy.
Conditions
- SCLC, Limited Stage
Interventions
- DRUG
-
Involved-Field Radiotherapy (IFRT) group
Carboplatin AUC 5 d1 + Etoposide 100 mg/m² d1-3 + thoracic involved-field radiotherapy (IFRT), q3w × 4 cycles. Post-concurrent CCRT, non-PD subjects receive maintenance adebrelimab 1200 mg IV q3w.
- DRUG
-
Nodal residual-field radiotherapy group
Carboplatin/etoposide + thoracic residual-field RT, followed by maintenance adebrelimab in non-PD patients
Sponsors & Collaborators
-
Henan Cancer Hospital
lead OTHER_GOV
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-01
- Primary Completion
- 2029-04-01
- Completion
- 2029-04-01
Countries
- China
Study Locations
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