Small Cell Lung Cancer (SCLC)NCT07434518
A Real-World Study Evaluating the Efficacy and Safety of Adebrelimab in Patients With Advanced SCLC
An observational study of Small Cell Lung Cancer (SCLC), run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The goal of this observational study is to evaluate the safety and efficacy of adebrelimab in the perioperative and advanced-stage treatment of small cell lung cancer （SCLC） under real-world conditions. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Small Cell Lung Cancer (SCLC)
- What is being tested?
- Adebrelimab (PD-L1 inhibitor)
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 27 Jan 2026to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult advanced SCLC patients who are eligible for receiving adebrelimab treatment.
Who may be able to join
- Histologically or cytologically confirmed extensive-stage small cell lung cancer;
- Age ≥ 18 years;
- The investigator determines that the patient is eligible for or is already receiving adebrelimab treatment.
Who cannot join
- Patients concurrently receiving other immune-modulating drugs or therapies;
- Patients currently participating in other interventional studies;
- Patients with concurrent other malignancies;
- Patients with missing key study-related data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Qian Xue, PhD contact
China1 site, 1 recruiting
- Recruiting
Shanghai General Hospital
Shanghai, 201620
Shanghai General Hospital, 86-021-63240090, shiyicss@126.com
About this study
Official title: A Real-world Study on the Efficacy and Safety of Adebrelimab in the Treatment of Advanced-stage Small Cell Lung Cancer
The goal of this observational study is to evaluate the safety and efficacy of adebrelimab in the perioperative and advanced-stage treatment of small cell lung cancer （SCLC） under real-world conditions. The main questions it aims to answer are:
- The safety of adebrelimab treatment in patients with advanced SCLC under real-world conditions, with a specific focus on the incidence of grade ≥3 immune-related adverse events. Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab.
- Observe and evaluate the efficacy of adebrelimab in patients with small cell lung cancer under real-world conditions. This includes overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR). Additionally, the study seeks to further explore the impact of patient baseline characteristics, such as brain metastases or liver metastases, and biomarkers on prognosis.
- Conditions
- Small Cell Lung Cancer (SCLC)
- Being tested
- Adebrelimab (PD-L1 inhibitor)
- Keywords
- Safety, efficacy, SCLC
- 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.
Adebrelimab (PD-L1 inhibitor)Biological
Investigating the efficacy and long-term safety of adebrelimab in different subgroups of SCLC patients (e.g., elderly patients, patients with comorbidities) in a real-world setting.
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune-related adverse events
The incidence of grade ≥3 immune-related adverse events. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab.
Secondary outcomes (7)
Overall survival (OS)
The efficacy of adebrelimab in patients with small cell lung cancer under real-world conditions. Record the survival （days） post first Adebrelimab Treatment.
Measured: From enrollment to the end of treatment at 12 months.
Progression-free survival (PFS)
The efficacy of adebrelimab in patients with small cell lung cancer under real-world conditions. This includes progression-free survival (PFS) days post Adebrelimab treatment.
Measured: From enrollment to the end of treatment at 12 months.]
Objective response rate (ORR)
The efficacy of adebrelimab in patients with small cell lung cancer under real-world conditions. This includes Objective response rate (ORR) post Adebrelimab treatment.
Measured: From enrollment to the end of treatment at 12 months.
Disease control rate (DCR)
The efficacy of adebrelimab in patients with small cell lung cancer under real-world conditions. This includes Disease control rate (DCR) post Adebrelimab treatment.
Measured: From enrollment to the end of treatment at 12 months.
The density of immune cells in peripheral blood before and after treatment
Although PD-L1 expression is currently a recognized predictive biomarker for efficacy, its predictive value varies significantly across different tumor types, detection platforms, and cutoff thresholds. Real-world data can be utilized through multi-omics integrated analysis (such as genomics, transcriptomics, and immune microenvironment characteristics) to identify novel biomarkers. We will measure immune cell density in peripheral blood before and after treatment, to determine whether they correlate with clinical response. This could provide a non-invasive approach for monitoring treatment efficacy.
Measured: From enrollment to the end of treatment at 90 days.
Incidence of Adverse Events
The incidence of adverse events. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Measured: Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab.
Incidence of Serious Adverse Events
The incidence of serious adverse events. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Measured: Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start27 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung Cancer (SCLC)Studies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Pulmonary Hospital, Shanghai, China, Shanghai Chest Hospital of Shanghai Jiao Tong University, Shanghai 10th People's Hospital, Shanghai Zhongshan Hospital, Huashan Hospital, RenJi Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine
- Responsible party
- Principal investigator, Zheng Ruan, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434518
- Sponsor's protocol ID
- 20250704064933814
- Status last verified
- Feb 2026
- First submitted
- 29 Jan 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study on the Efficacy and Safety of Adebrelimab in the Treatment of Advanced-stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07434518
- Acronym / sponsor ID
- 20250704064933814
- Conditions
- Small Cell Lung Cancer (SCLC)
- Keywords
- Safety, efficacy, SCLC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai Pulmonary Hospital, Shanghai, China, Shanghai Chest Hospital of Shanghai Jiao Tong University, Shanghai 10th People's Hospital, Shanghai Zhongshan Hospital, Huashan Hospital, RenJi Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine
- Study start
- 27 Jan 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 25 Feb 2026 (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.
The goal of this observational study is to evaluate the safety and efficacy of adebrelimab in the perioperative and advanced-stage treatment of small cell lung cancer （SCLC） under real-world conditions. The main questions it aims to answer are:
- The safety of adebrelimab treatment in patients with advanced SCLC under real-world conditions, with a specific focus on the incidence of grade ≥3 immune-related adverse events. Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab.
- Observe and evaluate the efficacy of adebrelimab in patients with small cell lung cancer under real-world conditions. This includes overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR). Additionally, the study seeks to further explore the impact of patient baseline characteristics, such as brain metastases or liver metastases, and biomarkers on prognosis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult advanced SCLC patients who are eligible for receiving adebrelimab treatment.
Key inclusion criteria (3 listed)
- Histologically or cytologically confirmed extensive-stage small cell lung cancer;
- Age ≥ 18 years;
- The investigator determines that the patient is eligible for or is already receiving adebrelimab treatment.
Key exclusion criteria (4 listed)
- Patients concurrently receiving other immune-modulating drugs or therapies;
- Patients currently participating in other interventional studies;
- Patients with concurrent other malignancies;
- Patients with missing key study-related data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adebrelimab (PD-L1 inhibitor)Investigating the efficacy and long-term safety of adebrelimab in different subgroups of SCLC patients (e.g., elderly patients, patients with comorbidities) in a real-world setting. | Biological | – |
Primary outcome
Immune-related adverse events
Time frame: Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab.
The incidence of grade ≥3 immune-related adverse events. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
7 secondary outcomes
Overall survival (OS)
Time frame: From enrollment to the end of treatment at 12 months.
Progression-free survival (PFS)
Time frame: From enrollment to the end of treatment at 12 months.]
Objective response rate (ORR)
Time frame: From enrollment to the end of treatment at 12 months.
Disease control rate (DCR)
Time frame: From enrollment to the end of treatment at 12 months.
The density of immune cells in peripheral blood before and after treatment
Time frame: From enrollment to the end of treatment at 90 days.
Incidence of Adverse Events
Time frame: Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab.
Incidence of Serious Adverse Events
Time frame: Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
Qian Xue, PhD contact
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 (SCLC), run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 25 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qingnan Zhao, PhD (+86 (021)37798597, zhaoqingnan2010@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune-related adverse events (time frame: Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab.). 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 25 Feb 2026.