Limited Stage Small-Cell Lung CancerDREAMNCT07161388
Durvalumab Consolidation After Chemoradiation Therapy for Limited Stage SCLC in China
An observational study of Limited Stage Small-Cell Lung Cancer, run by AstraZeneca at 21 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Limited Stage Small-Cell Lung Cancer
- How many people
- 200 participants
- Where
- 21 sitesChina
- Study dates
- 17 Nov 2025to 30 Sep 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult male or female patients (with age ≥18 years old) who able to provide informed consent received platinum-based cCRT/sCRT followed by durvalumab consolidation as first-line treatment at the discretion of physicians and no disease progression following cCRT/sCRT
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
21 sites in 1 country
China21 sites, 20 recruiting
- Recruiting
Research Site
Beijing
- Recruiting
Research Site
Cangzhou
- Recruiting
Research Site
Dongguan
- Recruiting
Research Site
Fuzhou
- Recruiting
Research Site
Guangzhou
- Recruiting
Research Site
Huzhou
- Recruiting
Research Site
Jinan, 250117
- Recruiting
Research Site
Jinan
- Recruiting
Research Site
Nanjing
- Recruiting
Research Site
Nanning
- Recruiting
Research Site
Ningbo
- Recruiting
Research Site
Shanghai
- Recruiting
Research Site
Shenyang
- Recruiting
Research Site
Shijiazhuang
- Recruiting
Research Site
Taiyuan
- Recruiting
Research Site
Tianjing
- Terminated
Research Site
Tianjing
- Recruiting
Research Site
Wuhan
- Recruiting
Research Site
Wuxi
- Recruiting
Research Site
Yangzhou
- Recruiting
Research Site
Zhengzhou
About this study
Official title: Durvalumab Consolidation After Chemoradiation Therapy (CRT) for Patients With Limited Stage Small-Cell Lung Cancer in China: A Multicentre, Observational Study (DREAM)
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.
Read the detailed description
In this study, the effectiveness and safety profile of durvalumab consolidation following CRT in patients with LS-SCLC will be investigated in a real-world setting. Clinical outcomes will be explored across different CRT modalities and regimens according to local practice. Additionally, evidence will be generated on durvalumab consolidation following CRT regardless of concurrent or sequential setting. The subsequent treatment patterns of patients who experience disease progression during or after durvalumab consolidation will also be evaluated.
- Conditions
- Limited Stage Small-Cell Lung Cancer
- Keywords
- SCLC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| LS-SCLC | Patients with LS-SCLC who received platinum-based cCRT/sCRT followed by durvalumab consolidation as first line treatment at the discretion of physicians. |
What is being measured
The primary outcome is the main question the study is designed to answer.
rwPFS
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.
Measured: From 3 months before enrolment to follow-up of up to 36 months
Secondary outcomes (2)
TTD
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.
Measured: From 3 months before enrolment to follow-up of up to 36 months
OS
From first dose of durvalumab consolidation treatment until the date of death due to any cause. 6, 12, 18, and 24-months landmark rate of OS will be described.
Measured: From 3 months before enrolment to follow-up of up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start17 Nov 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limited Stage Small-Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- JinMing Yu, Doctor, Principal investigator, Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute, Shandong Cancer Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161388
- Sponsor's protocol ID
- D419QR00019
- Acronym
- DREAM
- Status last verified
- Sep 2026
- First submitted
- 5 Sep 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.