A Real-World Study Evaluating the Efficacy and Safety of Adebrelimab in Patients With Advanced SCLC

February 20, 2026 updated by: Zheng Ruan, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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:

  1. 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.
  2. 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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Qian Xue, PhD
  • Phone Number: +86 (021)37798597

Study Locations

  • China
      • Shanghai, China, 201620
        • Recruiting
        • Shanghai General Hospital
        • Contact:
          • Shanghai General Hospital
          • Phone Number: 86-021-63240090
          • Email: shiyicss@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult advanced SCLC patients who are eligible for receiving adebrelimab treatment.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: From enrollment to the end of treatment at 12 months.
The efficacy of adebrelimab in patients with small cell lung cancer under real-world conditions. Record the survival （days） post first Adebrelimab Treatment.
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.]
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.
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.
The efficacy of adebrelimab in patients with small cell lung cancer under real-world conditions. This includes Objective response rate (ORR) post Adebrelimab treatment.
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 efficacy of adebrelimab in patients with small cell lung cancer under real-world conditions. This includes Disease control rate (DCR) post Adebrelimab treatment.
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.
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.
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.
The incidence of adverse events. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
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.
The incidence of serious adverse events. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Collaborators

Shanghai Zhongshan Hospital
RenJi Hospital
Huashan Hospital
Shanghai 10th People's Hospital
Shanghai Pulmonary Hospital, Shanghai, China
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai Chest Hospital of Shanghai Jiao Tong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

January 29, 2026

First Submitted That Met QC Criteria

February 20, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20250704064933814

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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