SCLC, Limited StageNCT07309211
Durvalumab as Consolidation Therapy in Patients With LS-SCLC Following sCRT
An observational study of SCLC, Limited Stage, run by The First Affiliated Hospital with Nanjing Medical University at 4 sites in China.
Trial summary
This is a retrospective, multi-centre, single arm study to assess the safety and efficacy of receiving Durvalumab in patients with Small Cell Lung Cancer Limited Stage (LS-SCLC) who have not progressed following sequential chemoradiotherapy (sCRT) in a real-world setting. The study will enroll 25 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SCLC, Limited Stage
- How many people
- 25 participants
- Where
- 4 sitesChina
- Study dates
- 8 Jul 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: The study will retrospectively collect cases of eligible LS-SCLC patients who received sCRT and have not progressed followed by receiving Durvalumab as consolidation therapy. The retrospective collection of cases for initiating the administration of Durvalumab spans from December 9, 2019, to April 10, 2025. Retrospective analysis of each case should meet all of the inclusion criteria and exclusion criteria for this study. Under no circumstances can there be exceptions to this rule.
Who may be able to join
- Aged ≥18 at initial diagnosis;
- Histological or cytological evidence of LS-SCLC (Stage I-III); Stage I-II must be medically inoperable;
- Received chemotherapy sequential with radiotherapy as first-line treatment and no progression, followed by receiving Durvalumab at least 1 dose as consolidation treatment until progression, unacceptable toxicity or for a maximum of 24 months;
- Start Durvalumab treatment within 3 months after sCRT;
- Permitted PCI;
- WHO PS 0-2 before sCRT.
Who cannot join
- ES-SCLC or mixed SCLC and NSCLC histology;
- Active or prior documented autoimmune or inflammatory disorders or uncontrolled intercurrent illness;
- Any unresolved toxicity (CTCAE Grade ≥ 2) from prior chemoradiotherapy; 4. Received concurrent chemoradiotherapy for LS-SCLC.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Cancer Hospital of Shandong First Medical University
Jinan
Nanjing Chest Hospital
Nanjing
The First Affiliated Hospital with Nanjing Medical University
Nanjing
The affiliated hospital of qingdao university
Qingdao
About this study
Official title: A Multi-centre, Retrospective Study Assessing Durvalumab as Consolidation Treatment for Patients With Limited-stage Small Cell Lung Cancer (LS-SCLC) Following by Sequential Chemoradiotherapy (sCRT)
This is a retrospective, multi-centre, single arm study to assess the safety and efficacy of receiving Durvalumab in patients with Small Cell Lung Cancer Limited Stage (LS-SCLC) who have not progressed following sequential chemoradiotherapy (sCRT) in a real-world setting. The study will enroll 25 patients. The primary endpoint of the study is the incidence of Grade 3 or 4 adverse events (AEs) within 6 months of starting Durvalumab (graded by CTCAE v.5.0). The secondary endpoints of the study include real-world progression-free survival (rwPFS, the time from the start of Durvalumab treatment to disease progression or death for any reason, which occurs first), objective response rate (ORR), duration of response (DoR) and disease control rate (DCR).
sCRT is more common in Mid-Eastern Chinese clinical practice. sCRT is also recommended in guideline of Chinese Society of Clinical Oncology (CSCO) Small-cell lung cancer. However, patients treated with sCRT were not included in the ADRIATIC study. So there is lack of data on safety and efficacy of Durvalumab post sCRT. Supplement real-world evidence (RWE) clinical data of sCRT in Chinese patients is needed to enhance the status of Durvalumab as a consolidation therapy for LS-SCLC.
The study will retrospectively collect cases of eligible LS-SCLC patients who received sCRT and have not progressed followed by receiving Durvalumab as consolidation therapy.
- Conditions
- SCLC, Limited Stage
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Grade 3 or 4 Adverse Events (AEs) within 6 months of starting Durvalumab [graded by Common Terminology Criteria for Adverse Event (CTCAE) v.5.0]
Measured: Within 6 months of starting Durvalumab
Secondary outcomes (4)
Real world PFS (rwPFS)
Measured: From date of the first dose of Durvalumab to date of objective disease progression or death, whichever came first, assessed up to 60 months
ORR (Objective response rate from starting with Durvalumab treatment)
Measured: Up to 60 months
DoR (Duration of response from starting with Durvalumab treatment)
Measured: From the earliest date of first documented evidence of confirmed CR or PR until the earliest date of disease progression or death from any cause, whichever comes first, Up to 60 months
DCR (Disease control rate from staring with Durvalumab treatment)
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start8 Jul 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCLC, Limited StageStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin Zhao, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309211
- Sponsor's protocol ID
- 2025-SR-343.A1
- Status last verified
- Oct 2026
- First submitted
- 1 Dec 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Retrospective Study Assessing Durvalumab as Consolidation Treatment for Patients With Limited-stage Small Cell Lung Cancer (LS-SCLC) Following by Sequential Chemoradiotherapy (sCRT)
- ClinicalTrials.gov ID
- NCT07309211
- Acronym / sponsor ID
- 2025-SR-343.A1
- Conditions
- SCLC, Limited Stage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a retrospective, multi-centre, single arm study to assess the safety and efficacy of receiving Durvalumab in patients with Small Cell Lung Cancer Limited Stage (LS-SCLC) who have not progressed following sequential chemoradiotherapy (sCRT) in a real-world setting. The study will enroll 25 patients. The primary endpoint of the study is the incidence of Grade 3 or 4 adverse events (AEs) within 6 months of starting Durvalumab (graded by CTCAE v.5.0). The secondary endpoints of the study include real-world progression-free survival (rwPFS, the time from the start of Durvalumab treatment to disease progression or death for any reason, which occurs first), objective response rate (ORR), duration of response (DoR) and disease control rate (DCR).
sCRT is more common in Mid-Eastern Chinese clinical practice. sCRT is also recommended in guideline of Chinese Society of Clinical Oncology (CSCO) Small-cell lung cancer. However, patients treated with sCRT were not included in the ADRIATIC study. So there is lack of data on safety and efficacy of Durvalumab post sCRT. Supplement real-world evidence (RWE) clinical data of sCRT in Chinese patients is needed to enhance the status of Durvalumab as a consolidation therapy for LS-SCLC.
The study will retrospectively collect cases of eligible LS-SCLC patients who received sCRT and have not progressed followed by receiving Durvalumab as consolidation therapy.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will retrospectively collect cases of eligible LS-SCLC patients who received sCRT and have not progressed followed by receiving Durvalumab as consolidation therapy. The retrospective collection of cases for initiating the administration of Durvalumab spans from December 9, 2019, to April 10, 2025. Retrospective analysis of each case should meet all of the inclusion criteria and exclusion criteria for this study. Under no circumstances can there be exceptions to this rule.
Key inclusion criteria (6 listed)
- Aged ≥18 at initial diagnosis;
- Histological or cytological evidence of LS-SCLC (Stage I-III); Stage I-II must be medically inoperable;
- Received chemotherapy sequential with radiotherapy as first-line treatment and no progression, followed by receiving Durvalumab at least 1 dose as consolidation treatment until progression, unacceptable toxicity or for a maximum of 24 months;
- Start Durvalumab treatment within 3 months after sCRT;
- Permitted PCI;
Key exclusion criteria (3 listed)
- ES-SCLC or mixed SCLC and NSCLC histology;
- Active or prior documented autoimmune or inflammatory disorders or uncontrolled intercurrent illness;
- Any unresolved toxicity (CTCAE Grade ≥ 2) from prior chemoradiotherapy; 4. Received concurrent chemoradiotherapy for LS-SCLC.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Grade 3 or 4 Adverse Events (AEs) within 6 months of starting Durvalumab [graded by Common Terminology Criteria for Adverse Event (CTCAE) v.5.0]
Time frame: Within 6 months of starting Durvalumab
4 secondary outcomes
Real world PFS (rwPFS)
Time frame: From date of the first dose of Durvalumab to date of objective disease progression or death, whichever came first, assessed up to 60 months
ORR (Objective response rate from starting with Durvalumab treatment)
Time frame: Up to 60 months
DoR (Duration of response from starting with Durvalumab treatment)
Time frame: From the earliest date of first documented evidence of confirmed CR or PR until the earliest date of disease progression or death from any cause, whichever comes first, Up to 60 months
DCR (Disease control rate from staring with Durvalumab treatment)
Time frame: Up to 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SCLC, Limited Stage, run by The First Affiliated Hospital with Nanjing Medical University at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Grade 3 or 4 Adverse Events (AEs) within 6 months of starting Durvalumab [graded by Common Terminology Criteria for Adverse Event (CTCAE) v.5.0] (time frame: Within 6 months of starting Durvalumab). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.