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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)

Status: Recruiting
Location: See all (4) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Aged ≥18 at initial diagnosis;

• Histological or cytological evidence of LS-SCLC (Stage I-III); Stage I-II must be medically inoperable;

• 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;

• Start Durvalumab treatment within 3 months after sCRT;

• Permitted PCI;

• WHO PS 0-2 before sCRT.

Locations
Other Locations
China
Cancer Hospital of Shandong First Medical University
RECRUITING
Jinan
Nanjing Chest Hospital
NOT_YET_RECRUITING
Nanjing
The First Affiliated Hospital with Nanjing Medical University
RECRUITING
Nanjing
The affiliated hospital of qingdao university
RECRUITING
Qingdao
Contact Information
Primary
Xin Zhao
xinzhao1104@163.com
18066047640
Time Frame
Start Date: 2025-07-08
Estimated Completion Date: 2026-12
Participants
Target number of participants: 25
Sponsors
Leads: The First Affiliated Hospital with Nanjing Medical University

This content was sourced from clinicaltrials.gov

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