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NCT Number: NCT07434518

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

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.

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Key information

Conditions

Small Cell Lung Cancer (SCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai General Hospital

Shanghai, 201620, China

Location status: Recruiting

Location contact

Shanghai General Hospital

CONTACT

[email protected]

86-021-63240090

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Qian Xue, PhD

CONTACT

+86 (021)37798597

Qingnan Zhao, PhD

CONTACT

[email protected]

+86 (021)37798597

Sponsors and collaborators

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Other

Collaborators

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

Registry information

Official study title

A Real-world Study on the Efficacy and Safety of Adebrelimab in the Treatment of Advanced-stage Small Cell Lung Cancer

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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