Durvalumab Consolidation After Chemoradiation Therapy for Limited Stage SCLC in China
Recruiting · NCT07161388 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →What this trial is about
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 in real-world setting.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
21 locations listed.
- Research Site - Beijing, China
- Research Site - Cangzhou, China
- Research Site - Dongguan, China
- Research Site - Fuzhou, China
- Research Site - Guangzhou, China
- Research Site - Huzhou, China
- Research Site - Jinan, China
- Research Site - Jinan, China
- Research Site - Nanjing, China
- Research Site - Nanning, China
- Research Site - Ningbo, China
- Research Site - Shanghai, China
- Research Site - Shenyang, China
- Research Site - Shijiazhuang, China
- Research Site - Taiyuan, China
- Research Site - Tianjing, China
- Research Site - Tianjing, China
- Research Site - Wuhan, China
- Research Site - Wuxi, China
- Research Site - Yangzhou, China
- Research Site - Zhengzhou, China