Clinical Trial

Durvalumab as Consolidation Therapy in Patients With LS-SCLC Following sCRT

Recruiting
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Summary
This is a retrospective, multi-centre, single arm study to assess the safety and efficacy of receiving Durvalumab in patients with Small Cell Lung Cancer Limited Stage (LS-SCLC) who have not progressed following sequential chemoradiotherapy (sCRT) in a real-world setting. The study will enroll 25 patients. The primary endpoint of the study is the incidence of Grade 3 or 4 adverse events (AEs) within 6 months of starting Durvalumab (graded by CTCAE v.5.0). The secondary endpoints of the study include real-world progression-free survival (rwPFS, the time from the start of Durvalumab treatment to disease progression or death for any reason, which occurs first), objective response rate (ORR), duration of response (DoR) and disease control rate (DCR). sCRT is more common in Mid-Eastern Chinese clinical practice. sCRT is also recommended in guideline of Chinese Society of Clinical Oncology (CSCO) Small-cell lung cancer. However, patients treated with sCRT were not included in the ADRIATIC study. So there is lack of data on safety and efficacy of Durvalumab post sCRT. Supplement real-world evidence (RWE) clinical data of sCRT in Chinese patients is needed to enhance the status of Durvalumab as a consolidation therapy for LS-SCLC. The study will retrospectively collect cases of eligible LS-SCLC patients who received sCRT and have not progressed followed by receiving Durvalumab as consolidation therapy.
Trial Details
NCT Number NCT07309211
Lead Sponsor The First Affiliated Hospital with Nanjing Medical University
Conditions SCLC, Limited Stage
Enrollment 25 participants
Start Date 2025-07-08
Primary Completion 2025-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-12-30