NCT06530797

A Multicenter Real-World Cohort Study of Adebrelimab Injection in the Treatment of Extensive-Stage Small Cell Lung Cancer

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The purpose of this observational study is to evaluate the safety and efficacy of Adebrelimab Injection in extensive-stage small cell lung cancer (ES-SCLC) under real-world conditions. Specifically, the study aims to assess the treatment of Adebrelimab Injection across various subgroups of ES-SCLC patients. The goal is to provide information on treatment patterns and effectiveness in real-life settings, explore potential predictive or prognostic biomarkers, and preliminarily evaluate the pharmacoeconomic indicators of Adebrelimab Injection treatment for extensive-stage small cell lung cancer.

Detailed description

This trial is a multicenter, non-interventional real-world study aimed at evaluating the safety and efficacy of Adebrelimab in the treatment of extensive-stage small cell lung cancer (ES-SCLC). The study plans to enroll 2000 patients with extensive-stage small cell lung cancer, collecting relevant information such as demographics, medical history, treatment regimens including Adebrelimab, clinical outcomes, and adverse events. Patients who have already decided to receive Adebrelimab treatment before enrollment will be categorized into one of the following two cohorts based on their disease stage and prior treatments: Cohort 1: First-line treatment for advanced stage Cohort 2: Second-line and beyond for advanced stage The Adebrelimab-containing treatment regimen for each patient will be assessed and selected by the investigator, and some treatment regimens are provided in this protocol for reference. After patients discontinue Adebrelimab treatment, they will be followed up until death, loss to follow-up, withdrawal of informed consent/voluntary withdrawal, or study termination/closure, whichever occurs first. As this is an observational study, treatments, procedures, visits, and examinations are based on the routine clinical experience of the attending physicians. The examinations listed in the protocol are recommended or for reference, with no mandatory requirements. The primary source of data for this study will be patients' routine medical records. During the period of Adebrelimab treatment, data on the administration regimen, routine examinations, adverse events, concomitant medications, and efficacy evaluations will be collected. When patients permanently discontinue Adebrelimab treatment for any reason (including but not limited to disease progression, intolerable toxicity, patient request, etc.), the reasons for discontinuation, adverse events/serious adverse events (up to 90 days after the last dose of Adebrelimab), the time of radiographic disease progression (if not the reason for discontinuation), subsequent anti-tumor treatments, and survival follow-up data will be collected. This study will explore potential predictive or prognostic biomarkers for ES-SCLC, so patients are requested to provide 10 tumor tissue slides whenever possible.

Conditions

• Extensive-stage Small Cell Lung Cancer (ES-SCLC)

Interventions

Type	Name	Description
DRUG	First-line Adebrelimab regiment for advanced stage ES-SCLC	First-line Adebrelimab in any regiment for advanced stage ES-SCLC
DRUG	Second-line and beyond Adebrelimab regiment for advanced stage ES-SCLC	Second-line and beyond Adebrelimab in any regiment for advanced stage ES-SCLC

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2024-07-31
• Last updated: 2024-07-31