Small-cell Lung CancerNCT07050472
Durvalumab After Concurrent Chemoradiotherapy (cCRT) for Limited-stage Small-cell Lung Cancer (LS-SCLC)
An observational study of Small-cell Lung Cancer, run by Anhui Shi, MD at 1 site in China.
Trial summary
This is a retrospective, single-center study evaluating the effectiveness and safety of consolidative durvalumab after cCRT in LS-SCLC in real-world setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small-cell Lung Cancer
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 11 Aug 2025to 12 Aug 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: Histologically or cytologically documented limited-stage SCLC (Stage I-III SCLC [T any, N any, M0] according to the American Joint Committee on Cancer Staging Manual [AJCC Cancer Staging Manual, 9th Edition] or the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology [IASLC Staging Manual in Thoracic Oncology 2016]).
Who may be able to join
- Aged ≥18 at initial diagnosis.
- Histologically or cytologically documented limited-stage SCLC (Stage I-III SCLC [T any, N any, M0] according to the American Joint Committee on Cancer Staging Manual [AJCC Cancer Staging Manual, 9th Edition] or the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology [IASLC Staging Manual in Thoracic Oncology 2016]).
- Received concurrent chemoradiotherapy (cCRT) as first-line treatment and consolidative durvalumab prior to disease progression or death:
- Received 4 cycles of platinum-based chemotherapy concurrent with radiotherapy.
- The chemotherapy regimen must contain carboplatin/cisplatin and etoposide.
- Received a total dose of radiation of 60 to 66 Gy over 6 weeks for standard QD radiation schedules, 45 Gy over 3 weeks or a simultaneous integrated boost of 54 Gy over 3 weeks for hyperfractionated BID radiation schedules.
- Radiotherapy must have commenced no later than the end of Cycle 2 of chemotherapy.
- Received at least 1 dose of durvalumab. The first dose of durvalumab received between 1 Jan 2020 and 31 Dec 2023 at Peking University Cancer Hospital.
Who cannot join
- Mixed SCLC and NSCLC histology.
- Participated in other interventional clinical trial for the treatment of any cancer during durvalumab therapy.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Cancer Hospital and Institute
Beijing, Beijing Municipality, 100142
About this study
Official title: Durvalumab as Consolidation Therapy After Concurrent Chemoradiotherapy (cCRT) for Patients With Limited-stage Small-cell Lung Cancer (LS-SCLC): A Retrospective, Single-center, Real-world Cohort Study
This is a retrospective, single-center study evaluating the effectiveness and safety of consolidative durvalumab after cCRT in LS-SCLC in real-world setting.
Read the detailed description
Eligible LS-SCLC patients who received cCRT, and subsequent durvalumab from January 1st, 2020 till December 31st, 2023 will be identified and included for retrospective data collection and analyses in this study. Approximately 35~45 patients are planned to be enrolled. The first date of the presence of durvalumab treatment will be considered the index date for patients. Data is planned to be collected from date of histologically diagnosis up to June 27, 2025. The primary endpoint real-world PFS is defined as the time from the index date to disease progression (determined based on either radiological or clinical evidence) or death for any reason. Duration of durvalumab treatment and 2 year (relative to the first dose of durvalumab) rwPFS rate and OS rate will be measured.
Study data will come from what have been generated from routine clinical practice in the study hospital, e.g., the diagnosis, treatment and tumor assessments (CT or MRI, usually every 3 months for years 1~2, and every 6 months for years 3~5) information. Data collection, cleaning, and query will follow the traditional clinical study execution process. Investigators at study site will be responsible to ensure that data is accurate, clear, and traceable.
- Conditions
- Small-cell Lung Cancer
- Keywords
- limited stage small-cell lung cancer, CRT, immunotherapy
- Medical subject headings
- Small Cell Lung Carcinoma
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 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
rwPFS
From the start of Durvalumab treatment to disease progression (tumor assessed by investigator) or death for any reason
Measured: Up to 60 months
Secondary outcomes (3)
DoT
Time from the start of Durvalumab treatment to the date of durvalumab discontinuation or death
Measured: Up to 60 months
real-world progression free survival rate at 24 months(rwPFS24)
Kaplan-Meier estimate of rwPFS (assessed by investigator) at 24 months after first dose of durvalumab
Measured: 24 months after first dose of durvalumab
overall survival rate at 24 months (OS24)
Kaplan-Meier estimate of OS (assessed by investigator) at 24 months after first dose of durvalumab
Measured: 24 months after first dose of durvalumab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start11 Aug 2025
- Primary completion12 Aug 2025
- Study completion12 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small-cell Lung CancerStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Shi, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anhui Shi, MD, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050472
- Sponsor's protocol ID
- 2025YJZ41
- Status last verified
- Feb 2026
- First submitted
- 12 Jun 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Durvalumab as Consolidation Therapy After Concurrent Chemoradiotherapy (cCRT) for Patients With Limited-stage Small-cell Lung Cancer (LS-SCLC): A Retrospective, Single-center, Real-world Cohort Study
- ClinicalTrials.gov ID
- NCT07050472
- Acronym / sponsor ID
- 2025YJZ41
- Conditions
- Small-cell Lung Cancer
- Keywords
- limited stage small-cell lung cancer, CRT, immunotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Anhui Shi, MDUniversity, hospital or other
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- 12 Aug 2025 (actual)
- Study completion
- 12 Aug 2025 (actual)
- First posted
- 3 Jul 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, single-center study evaluating the effectiveness and safety of consolidative durvalumab after cCRT in LS-SCLC in real-world setting.
Detailed description
Eligible LS-SCLC patients who received cCRT, and subsequent durvalumab from January 1st, 2020 till December 31st, 2023 will be identified and included for retrospective data collection and analyses in this study. Approximately 35~45 patients are planned to be enrolled. The first date of the presence of durvalumab treatment will be considered the index date for patients. Data is planned to be collected from date of histologically diagnosis up to June 27, 2025. The primary endpoint real-world PFS is defined as the time from the index date to disease progression (determined based on either radiological or clinical evidence) or death for any reason. Duration of durvalumab treatment and 2 year (relative to the first dose of durvalumab) rwPFS rate and OS rate will be measured.
Study data will come from what have been generated from routine clinical practice in the study hospital, e.g., the diagnosis, treatment and tumor assessments (CT or MRI, usually every 3 months for years 1~2, and every 6 months for years 3~5) information. Data collection, cleaning, and query will follow the traditional clinical study execution process. Investigators at study site will be responsible to ensure that data is accurate, clear, and traceable.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LS-SCLC | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Histologically or cytologically documented limited-stage SCLC (Stage I-III SCLC [T any, N any, M0] according to the American Joint Committee on Cancer Staging Manual [AJCC Cancer Staging Manual, 9th Edition] or the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology [IASLC Staging Manual in Thoracic Oncology 2016]).
Key inclusion criteria (8 listed)
- Aged ≥18 at initial diagnosis.
- Histologically or cytologically documented limited-stage SCLC (Stage I-III SCLC [T any, N any, M0] according to the American Joint Committee on Cancer Staging Manual [AJCC Cancer Staging Manual, 9th Edition] or the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology [IASLC Staging Manual in Thoracic Oncology 2016]).
- Received concurrent chemoradiotherapy (cCRT) as first-line treatment and consolidative durvalumab prior to disease progression or death:
Key exclusion criteria (2 listed)
- Mixed SCLC and NSCLC histology.
- Participated in other interventional clinical trial for the treatment of any cancer during durvalumab therapy.
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
rwPFS
Time frame: Up to 60 months
From the start of Durvalumab treatment to disease progression (tumor assessed by investigator) or death for any reason
3 secondary outcomes
DoT
Time frame: Up to 60 months
real-world progression free survival rate at 24 months(rwPFS24)
Time frame: 24 months after first dose of durvalumab
overall survival rate at 24 months (OS24)
Time frame: 24 months after first dose of durvalumab
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 12 Feb 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small-cell Lung Cancer, run by Anhui Shi, MD at 1 site 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 8 inclusion and 2 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 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
rwPFS (time frame: Up to 60 months). 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 12 Feb 2026.