Durvalumab Consolidation After Chemoradiation Therapy for Limited Stage SCLC in China
DREAM
1 other identifier
observational
200
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2025
Typical duration for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2025
CompletedFirst Posted
Study publicly available on registry
September 8, 2025
CompletedStudy Start
First participant enrolled
November 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2028
April 2, 2026
March 1, 2026
2.9 years
September 5, 2025
April 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
From 3 months before enrolment to follow-up of up to 36 months
Secondary Outcomes (2)
TTD
From 3 months before enrolment to follow-up of up to 36 months
OS
From 3 months before enrolment to follow-up of up to 36 months
Other Outcomes (5)
TRAE, SAE, irAE, other AEs
From 3 months before enrolment to follow-up of up to 36 months
TFST
From 3 months before enrolment to follow-up of up to 36 months
Patterns of progression and post-progression therapy.
From 2 months before enrolment to follow-up of up to 35 months
- +2 more other outcomes
Study Arms (1)
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.
Eligibility Criteria
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
You may qualify if:
- 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)
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (24)
Research Site
Beijing, China
Research Site
Cangzhou, China
Research Site
Dongguan, China
Research Site
Fuzhou, China
Research Site
Guangzhou, China
Research Site
Guangzhou, China
Research Site
Huzhou, China
Research Site
Jinan, 250117, China
Research Site
Jinan, China
Research Site
Nanjing, China
Research Site
Nanning, China
Research Site
Ningbo, China
Research Site
Shanghai, China
Research Site
Shanghai, China
Research Site
Shenyang, China
Research Site
Shenzhen, China
Research Site
Shijiazhuang, China
Research Site
Taiyuan, China
Research Site
Tianjing, China
Research Site
Wuhan, China
Research Site
Wuxi, China
Research Site
Yangzhou, China
Research Site
Zhengzhou, China
Research Site
Zhengzhou, China
Study Officials
- PRINCIPAL INVESTIGATOR
JinMing Yu, Doctor
Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute, Shandong Cancer Hospital)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2025
First Posted
September 8, 2025
Study Start
November 17, 2025
Primary Completion (Estimated)
September 30, 2028
Study Completion (Estimated)
September 30, 2028
Last Updated
April 2, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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.