Clinical trial · Observational
Durvalumab Consolidation After Chemoradiation Therapy for Limited Stage SCLC in China
Durvalumab Consolidation After Chemoradiation Therapy (CRT) for Patients With Limited Stage Small-Cell Lung Cancer in China: A Multicentre, Observational Study (DREAM)
NCT07161388CI-TRIAL-00120465DREAMrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Limited Stage Small-Cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- LS-SCLC
- description
- Patients with LS-SCLC who received platinum-based cCRT/sCRT followed by durvalumab consolidation as first line treatment at the discretion of physicians.
Primary outcomes (1)
- measure
- rwPFS
- timeFrame
- From 3 months before enrolment to follow-up of up to 36 months
- description
- From date of first dose of durvalumab consolidation treatment until progression as assessed in real-world, or death due to any cause. The primary measure of interest is the median rwPFS.
Secondary outcomes (2)
- measure
- TTD
- timeFrame
- From 3 months before enrolment to follow-up of up to 36 months
- description
- From date of first dose of durvalumab consolidation treatment until discontinuation of treatment for any reason, including disease progression, toxicity and death. The measure of interest is the median TTD.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.