Durvalumab Consolidation After Chemoradiation Therapy for Limited Stage SCLC in China (NCT07161388) | Clinical Trial Compass
RecruitingNot Applicable
Durvalumab Consolidation After Chemoradiation Therapy for Limited Stage SCLC in China
China200 participantsStarted 2025-11-17
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 i…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying durvalumab as a consolidation treatment after chemoradiation — does my treatment plan currently include chemoradiation, and would I even be at a stage where consolidation therapy like this would be considered?
2The trial is listed as Phase NA, which is unusual — can you help me understand what that means for how much is already known about the safety and effectiveness of durvalumab in this specific setting for limited-stage small-cell lung cancer?
3The primary outcome being measured is real-world progression-free survival, or rwPFS — can you explain what that means in practical terms, and what it would tell us about whether durvalumab is actually helping patients like me?
4Since this trial is recruiting in China, is it actually accessible to me given where I live and where I receive care, and what would the logistics of participating look like?
5Before considering a trial like this, is there a standard consolidation approach already recommended after chemoradiation for limited-stage small-cell lung cancer that I should know about and compare this to?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
rwPFS
Timeframe: From 3 months before enrolment to follow-up of up to 36 months