Small Cell Lung Cancer (SCLC)
Conditions
Keywords
Safety, efficacy, SCLC
Brief 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. 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.
Interventions
BIOLOGICALAdebrelimab (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.
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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 design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immune-related adverse events | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 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. |
| Progression-free survival (PFS) | 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. |
| Objective response rate (ORR) | 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. |
| Disease control rate (DCR) | 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. |
| The density of immune cells in peripheral blood before and after treatment | 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. |
| Incidence of Adverse Events | 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. |
| Incidence of Serious Adverse Events | 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. |
Countries
China
Contacts
CONTACTQingnan Zhao, PhD
CONTACTQian Xue, PhD
Outcome results
None listed