NCT07357532

Exploration of Treatment Strategies After Concurrent Chemoradiotherapy for LS-SCLC Guided by MRD

Exploration of Treatment Strategies After Concurrent Chemoradiotherapy for Limited-stage Small Cell Lung Cancer (LS-SCLC) Guided by Molecular Residual Disease (MRD)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study plans to enroll limited-stage small cell lung cancer (LS-SCLC) patients who have achieved disease control after concurrent chemoradiotherapy (cCRT). Tissue samples collected at initial diagnosis and serial peripheral blood samples obtained at multiple post-cCRT timepoints will be analyzed using targeted next-generation sequencing to investigate the correlation between molecular residual disease (MRD) status and tumor recurrence/metastasis. For patients with MRD-positive results, a therapeutic strategy combining immunotherapy with anti-angiogenic agents will be implemented with the aim of improving clinical outcomes.

Conditions

• Small Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	Adebrelimab Injection	Patients with MRD Positive will receive adebrelimab (1200 mg, D1, Q3W) , followed by ctDNA monitoring every 2 months (Year 1) and every 3 months (Year 2).The above treatment regimen will be maintained until disease progression, intolerable toxicity, completion of two years of treatment, subject-initiated withdrawal, or investigator-determined discontinuation.
DRUG	Apatinib Mesylate Tablets	Apatinib Mesylate Tablets (250 mg, QD) , followed by ctDNA monitoring every 2 months (Year 1) and every 3 months (Year 2).The above treatment regimen will be maintained until disease progression, intolerable toxicity, completion of two years of treatment, subject-initiated withdrawal, or investigator-determined discontinuation.

Timeline

• Start date: 2026-01-31
• Primary completion: 2028-09-26
• Completion: 2028-10-30
• First posted: 2026-01-22
• Last updated: 2026-01-22

Locations

1 site across 1 country: China