Durvalumab as Consolidation Therapy in Patients With LS-SCLC Following sCRT
NCT ID: NCT07309211
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
25 participants
OBSERVATIONAL
2025-07-08
2026-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Histological or cytological evidence of LS-SCLC (Stage I-III); Stage I-II must be medically inoperable;
3. Received chemotherapy sequential with radiotherapy as first-line treatment and no progression, followed by receiving Durvalumab at least 1 dose as consolidation treatment until progression, unacceptable toxicity or for a maximum of 24 months;
4. Start Durvalumab treatment within 3 months after sCRT;
5. Permitted PCI;
6. WHO PS 0-2 before sCRT.
Exclusion Criteria
2. Active or prior documented autoimmune or inflammatory disorders or uncontrolled intercurrent illness;
3. Any unresolved toxicity (CTCAE Grade ≥ 2) from prior chemoradiotherapy; 4. Received concurrent chemoradiotherapy for LS-SCLC.
18 Years
ALL
No
Sponsors
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The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
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Xin Zhao
Chief Physician
Locations
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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
Countries
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Central Contacts
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Other Identifiers
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2025-SR-343.A1
Identifier Type: -
Identifier Source: org_study_id