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Recruiting
NCT07161388
Durvalumab Consolidation After Chemoradiation Therapy for Limited Stage SCLC in China
Conditions: Limited Stage Small-Cell Lung Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 200
Sponsor: AstraZeneca
Location: Research Site Beijing
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 in real-world setting.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07161388). StuddyBuddy aggregates publicly available trial information.