RecruitingNCT07309211

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

A Multi-centre, Retrospective Study Assessing Durvalumab as Consolidation Treatment for Patients With Limited-stage Small Cell Lung Cancer (LS-SCLC) Following by Sequential Chemoradiotherapy (sCRT)


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

25 participants

Start Date

Jul 8, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates how well durvalumab — an immune checkpoint inhibitor — works as a consolidation treatment (maintenance therapy given after initial treatment) for patients with limited-stage small cell lung cancer (LS-SCLC) who completed chemoradiotherapy without disease progression. **You may be eligible if...** - You are 18 or older at initial diagnosis - You have limited-stage small cell lung cancer (SCLC), stages I-III (stage I-II must be medically inoperable) - You completed sequential chemoradiotherapy (chemo then radiation separately) without disease progression - You started durvalumab within 3 months of finishing chemoradiotherapy and received at least 1 dose **You may NOT be eligible if...** - You have extensive-stage SCLC (cancer that has spread widely) - You have mixed SCLC/NSCLC histology - You have an active autoimmune disease or are on high-dose immunosuppressants Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(4)

Cancer Hospital of Shandong First Medical University

Jinan, China

Nanjing Chest Hospital

Nanjing, China

The First Affiliated Hospital with Nanjing Medical University

Nanjing, China

The affiliated hospital of qingdao university

Qingdao, China

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NCT07309211


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