An observational study in Small-cell Lung Cancer, sponsored by Anhui Shi, MD. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-12.
Sponsored by Anhui Shi, MD · Observational
This is a retrospective, single-center study evaluating the effectiveness and safety of consolidative durvalumab after cCRT in LS-SCLC in real-world setting.
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.
1,203 studies on the registry are indexed under Small Cell Lung Carcinoma; 342 are open to participants now.
This study's enrollment of 45 is below the median of 150 across 121 observational studies indexed under Small Cell Lung Carcinoma.
Browse Small Cell Lung Carcinoma studies →Anhui Shi, MD is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Histologically or cytologically documented limited-stage SCLC (Stage I-III SCLC [T any, N any, M0] according to the American Joint Committee on Cancer Staging Manual [AJCC Cancer Staging Manual, 9th Edition] or the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology [IASLC Staging Manual in Thoracic Oncology 2016]).
Received concurrent chemoradiotherapy (cCRT) as first-line treatment and consolidative durvalumab prior to disease progression or death:
Exclusion Criteria:
rwPFS
From the start of Durvalumab treatment to disease progression (tumor assessed by investigator) or death for any reason
Time frame: Up to 60 months
DoT
Time from the start of Durvalumab treatment to the date of durvalumab discontinuation or death
Time frame: Up to 60 months
real-world progression free survival rate at 24 months(rwPFS24)
Kaplan-Meier estimate of rwPFS (assessed by investigator) at 24 months after first dose of durvalumab
Time frame: 24 months after first dose of durvalumab
overall survival rate at 24 months (OS24)
Kaplan-Meier estimate of OS (assessed by investigator) at 24 months after first dose of durvalumab
Time frame: 24 months after first dose of durvalumab
Adverse Events
AEs that occurred from the first dose of durvalumab to 90 days after the last dose of durvalumab or start of subsequent anticancer treatment
Time frame: From the first dose of durvalumab to 90 days after the last dose of durvalumab or start of subsequent anticancer treatment
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Anhui Shi, MD