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

NCT07309211 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2025-12-30

No results posted yet for this study

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.

Conditions

  • SCLC, Limited Stage

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-08
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07309211 on ClinicalTrials.gov