Durvalumab consolidation after chemoradiation for limited-stage small-cell lung cancer in China
Durvalumab Consolidation After Chemoradiation Therapy (CRT) for Patients With Limited Stage Small-Cell Lung Cancer in China: A Multicentre, Observational Study (DREAM)
AstraZeneca · NCT07161388
This project will test durvalumab given after chemoradiation in people with limited‑stage small‑cell lung cancer who have not progressed, to see how well it works and how safe it is in routine care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AstraZeneca (industry) |
| Drugs / interventions | durvalumab, chemotherapy, radiation |
| Locations | 21 sites (Beijing and 20 other locations) |
| Trial ID | NCT07161388 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter observational study in China that follows patients with limited‑stage small‑cell lung cancer (LS‑SCLC) who completed definitive chemoradiation and did not progress. Patients receiving durvalumab as consolidation—whether after concurrent or sequential chemoradiation—will be followed in real‑world practice to record effectiveness and safety outcomes. The study will compare outcomes across different local chemoradiation modalities and regimens and document patterns of subsequent therapy after progression. Data will be collected from participating sites in multiple Chinese cities to reflect routine clinical practice.
Who should consider this trial
Good fit: Adults (≥18 years) with histologically or cytologically confirmed limited‑stage SCLC (AJCC 8th Ed. Stage I–III) with ECOG performance status 0–2 who completed platinum‑based concurrent or sequential chemoradiation without disease progression and received durvalumab consolidation are the intended participants.
Not a fit: Patients with disease progression after chemoradiation, those with poor performance status outside ECOG 0–2, or those with extensive metastatic disease or tumors too large for definitive radiation are unlikely to benefit from this consolidation approach.
Why it matters
Potential benefit: If durvalumab consolidation shows favorable outcomes, it could prolong the time before cancer returns and offer a safer consolidation option after chemoradiation for LS‑SCLC patients.
How similar studies have performed: Immunotherapy has improved outcomes in extensive‑stage SCLC and PD‑L1 consolidation after chemoradiation succeeded in stage III non‑small cell lung cancer, but durvalumab consolidation specifically for limited‑stage SCLC has been less well studied and remains comparatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing and 20 other locations
- Research Site — Beijing, China (RECRUITING)
- Research Site — Cangzhou, China (RECRUITING)
- Research Site — Dongguan, China (RECRUITING)
- Research Site — Fuzhou, China (RECRUITING)
- Research Site — Guangzhou, China (RECRUITING)
- Research Site — Huzhou, China (RECRUITING)
- Research Site — Jinan, China (RECRUITING)
- Research Site — Jinan, China (RECRUITING)
- Research Site — Nanjing, China (RECRUITING)
- Research Site — Nanning, China (RECRUITING)
- Research Site — Ningbo, China (RECRUITING)
- Research Site — Shanghai, China (RECRUITING)
- Research Site — Shenyang, China (RECRUITING)
- Research Site — Shijiazhuang, China (RECRUITING)
- Research Site — Taiyuan, China (RECRUITING)
- Research Site — Tianjing, China (RECRUITING)
- Research Site — Tianjing, China (TERMINATED)
- Research Site — Wuhan, China (RECRUITING)
- Research Site — Wuxi, China (RECRUITING)
- Research Site — Yangzhou, China (RECRUITING)
- Research Site — Zhengzhou, China (RECRUITING)
Study contacts
- Principal investigator: JinMing Yu, Doctor — Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute, Shandong Cancer Hospital)
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Limited Stage Small-Cell Lung Cancer, SCLC