Durvalumab Consolidation After Chemoradiation Therapy for Limited Stage SCLC in China
ConditionLimited Stage Small-Cell Lung Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAstraZeneca
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed
Trial groups
200 Participants
are grouped into 1 trial groupLocations
21Research Site Beijing China
Research Site Cangzhou China
Research Site Dongguan China
Research Site Fuzhou China
Sponsors and collaborators
AstraZeneca
Lead sponsor
Source ClinicalTrials.gov