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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 population

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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Adebrelimab (PD-L1 inhibitor)

    Biological/Vaccine

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

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

Secondary outcomes

1

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.

Time frame
From enrollment to the end of treatment at 12 months.
2

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.

Time frame
From enrollment to the end of treatment at 12 months.]
3

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.

Time frame
From enrollment to the end of treatment at 12 months.
4

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.

Time frame
From enrollment to the end of treatment at 12 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Collaborator

Shanghai Chest Hospital of Shanghai Jiao Tong University

Collaborator

Shanghai 10th People's Hospital

Collaborator

Shanghai Zhongshan Hospital

Collaborator

Huashan Hospital

Collaborator

RenJi Hospital

Collaborator

Shanghai Tongji Hospital, Tongji University School of Medicine

Collaborator