Actively Recruiting
Durvalumab as Consolidation Therapy in Patients With LS-SCLC Following sCRT
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-12-30
25
Participants Needed
4
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Durvalumab as Consolidation Therapy in Patients With LS-SCLC Following sCRT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older at initial diagnosis
- Histological or cytological confirmation of Limited Stage Small Cell Lung Cancer (Stage I-III); Stage I-II must be medically inoperable
- Received sequential chemotherapy followed by radiotherapy as first-line treatment with no disease progression
- Received at least one dose of Durvalumab as consolidation treatment
- Started Durvalumab treatment within 3 months after completing sequential chemoradiotherapy
- Permitted to have received prophylactic cranial irradiation (PCI)
- World Health Organization performance status of 0 to 2 before sequential chemoradiotherapy
You will not qualify if you...
- Extensive Stage Small Cell Lung Cancer or mixed Small Cell Lung Cancer and Non-Small Cell Lung Cancer histology
- Active or prior autoimmune or inflammatory disorders or uncontrolled illness
- Any unresolved moderate or severe toxicity (Grade 2 or higher) from prior chemoradiotherapy
- Received concurrent chemoradiotherapy for Limited Stage Small Cell Lung Cancer
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Cancer Hospital of Shandong First Medical University
Jinan, China
Actively Recruiting
2
Nanjing Chest Hospital
Nanjing, China
Not Yet Recruiting
3
The First Affiliated Hospital with Nanjing Medical University
Nanjing, China
Actively Recruiting
4
The affiliated hospital of qingdao university
Qingdao, China
Actively Recruiting
Research Team
X
Xin Zhao
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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