Status:
RECRUITING
Durvalumab Consolidation After Chemoradiation Therapy for Limited Stage SCLC in China
Lead Sponsor:
AstraZeneca
Conditions:
Limited Stage Small-Cell Lung Cancer
Eligibility:
All Genders
18+ years
Brief Summary
This prospective, multicentre, observational study aims to assess the effectiveness and safety of durvalumab as consolidation treatment for patients with LS-SCLC who have not progressed following CRT ...
Detailed Description
In this study, the effectiveness and safety profile of durvalumab consolidation following CRT in patients with LS-SCLC will be investigated in a real-world setting. Clinical outcomes will be explored ...
Eligibility Criteria
Inclusion
- Able to provide informed consent
- Age ≥18 years
- Histologically or cytologically documented LS-SCLC (Stage I-III SCLC \[T any, N any, M0\] according to the American Joint Committee on Cancer Staging Manual \[AJCC Cancer Staging Manual, 8th Edition\], that can be safely treated with definitive radiation doses. Excludes T3-4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan)
- ECOG PS 0-2 (prior to the first dose of durvalumab after CRT)
- No disease progression following cCRT/sCRT (cCRT refers to chemotherapy and radiotherapy are administered with overlap; sCRT refers to chemotherapy and radiotherapy are delivered in a sequential manner with no overlap)
- Patients who received platinum-based cCRT/sCRT followed by durvalumab consolidation as first-line treatment at the discretion of physicians are eligible (the time interval from the end of cCRT/sCRT to the first dose of durvalumab consolidation should be within 3 months)
- Patients who started durvalumab consolidation ≤3 months before enrolment in the study will be allowed (irrespective of whether they continue to receive durvalumab at time of enrolment or already discontinued treatment)
Exclusion
- Patients treated with CRT only without subsequent durvalumab consolidation
- Patients received durvalumab or any other anti-PD-1/anti-PD-L1 antibodies along with CRT
- Patients who previously were involved, or currently are, or plan to be involved in any other interventional anti-cancer clinical studies for LS-SCLC
- Prior exposure to immune-mediated therapy including, but not limited to, other anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines
- Judgment by the investigator that the patient should not participate in the study because the patient is unlikely to comply with study procedures
Key Trial Info
Start Date :
November 17 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07161388
Start Date
November 17 2025
End Date
September 30 2028
Last Update
December 2 2025
Active Locations (23)
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1
Research Site
Beijing, China
2
Research Site
Cangzhou, China
3
Research Site
Changsha, China
4
Research Site
Dongguan, China