NCT07050472

Durvalumab After Concurrent Chemoradiotherapy (cCRT) for Limited-stage Small-cell Lung Cancer (LS-SCLC)

Durvalumab as Consolidation Therapy After Concurrent Chemoradiotherapy (cCRT) for Patients With Limited-stage Small-cell Lung Cancer (LS-SCLC): A Retrospective, Single-center, Real-world Cohort Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 45 (actual)
• Sponsor: Anhui Shi, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a retrospective, single-center study evaluating the effectiveness and safety of consolidative durvalumab after cCRT in LS-SCLC in real-world setting.

Detailed description

Eligible LS-SCLC patients who received cCRT, and subsequent durvalumab from January 1st, 2020 till December 31st, 2023 will be identified and included for retrospective data collection and analyses in this study. Approximately 35\~45 patients are planned to be enrolled. The first date of the presence of durvalumab treatment will be considered the index date for patients. Data is planned to be collected from date of histologically diagnosis up to June 27, 2025. The primary endpoint real-world PFS is defined as the time from the index date to disease progression (determined based on either radiological or clinical evidence) or death for any reason. Duration of durvalumab treatment and 2 year (relative to the first dose of durvalumab) rwPFS rate and OS rate will be measured. Study data will come from what have been generated from routine clinical practice in the study hospital, e.g., the diagnosis, treatment and tumor assessments (CT or MRI, usually every 3 months for years 1\~2, and every 6 months for years 3\~5) information. Data collection, cleaning, and query will follow the traditional clinical study execution process. Investigators at study site will be responsible to ensure that data is accurate, clear, and traceable.

Conditions

• Small-cell Lung Cancer

Timeline

• Start date: 2025-08-11
• Primary completion: 2025-08-12
• Completion: 2025-08-12
• First posted: 2025-07-03
• Last updated: 2026-02-12

Locations

1 site across 1 country: China