NCT07161388 Durvalumab Consolidation After Chemoradiation Therapy for Limited Stage SCLC in China
| NCT ID | NCT07161388 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AstraZeneca |
| Condition | Limited Stage Small-Cell Lung Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-11-17 |
| Primary Completion | 2028-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2025-11-17 with a primary completion date of 2028-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Contact & Investigator
JinMing Yu, Doctor
PRINCIPAL INVESTIGATOR
Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute, Shandong Cancer Hospital)
Frequently Asked Questions
Who can join the NCT07161388 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Limited Stage Small-Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07161388 currently recruiting?
Yes, NCT07161388 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT07161388 trial being conducted?
This trial is being conducted at Beijing, China, Cangzhou, China, Dongguan, China, Fuzhou, China and 11 additional locations.
Who is sponsoring the NCT07161388 clinical trial?
NCT07161388 is sponsored by AstraZeneca. The principal investigator is JinMing Yu, Doctor at Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute, Shandong Cancer Hospital). The trial plans to enroll 200 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.