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

NCT06530797 | Not Yet Recruiting

• 1 other identifier: OBU-SH-SCLC-RWS-001
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

Extensive-stage small cell lung cancer (ES-SCLC); Adebrelimab

Outcome Measures

Primary Outcomes (1)

• Safety (The occurrence of ≥3 grade AEs)

  The occurrence of ≥3 grade AEs

  From August 2024, patients will be followed up for 90 days after the last use of Adebrelimab

Secondary Outcomes (5)

• PFS

  Up to 2 years. From date of enrollment until the date of first documented progression, assessed up to 2 years.

• OS

  Up to 2 years. From date of enrollment until the date of death from any cause, assessed up to 2 years.

• DoR

  Up to 2 years. From date of enrollment until the date of first documented progression, assessed up to 2 years.

• ORR

  Up to 2 years. From date of enrollment until the date of first documented progression, assessed up to 2 years.

• DCR

  Up to 2 years. From date of enrollment until the date of first documented progression, assessed up to 2 years.

Study Arms (2)

First-line treatment for advanced stage

Any first-line regiment including Adebrelimab for advanced stage ES-SCLC

Drug: First-line Adebrelimab regiment for advanced stage ES-SCLC

Second-line and beyond for advanced stage

Any Second- or later-line and regiment including Adebrelimab for advanced stage ES-SCLC

Drug: Second-line and beyond Adebrelimab regiment for advanced stage ES-SCLC

Interventions

First-line Adebrelimab regiment for advanced stage ES-SCLC DRUG

First-line Adebrelimab in any regiment for advanced stage ES-SCLC

First-line treatment for advanced stage

Second-line and beyond Adebrelimab regiment for advanced stage ES-SCLC DRUG

Second-line and beyond Adebrelimab in any regiment for advanced stage ES-SCLC

Second-line and beyond for advanced stage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

For some adverse reactions with an incidence as low as 0.25%, further observation in a larger population in the real world is needed. Using NCSS PASS 21 software (LLC. Kaysville, Utah, USA, ncss.com/software/pass), it was calculated that approximately 2000 patients need to be observed in this study to ensure a confidence of no less than 99% in successfully observing at least one case of an adverse reaction with an incidence as low as 0.25%.

You may qualify if:

• Voluntarily sign the informed consent form and agree to participate in the study.
• Histopathologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).
• Age ≥ 18 years.
• Determined by the investigator to be eligible for Adebrelimab treatment.

You may not qualify if:

• Evidence of being a pregnant or lactating female.
• Currently receiving treatment as part of a blinded study protocol.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Related Publications (2)

• Wang J, Zhou C, Yao W, Wang Q, Min X, Chen G, Xu X, Li X, Xu F, Fang Y, Yang R, Yu G, Gong Y, Zhao J, Fan Y, Liu Q, Cao L, Yao Y, Liu Y, Li X, Wu J, He Z, Lu K, Jiang L, Hu C, Zhao W, Zhang B, Shi W, Zhang X, Cheng Y; CAPSTONE-1 Study Group. Adebrelimab or placebo plus carboplatin and etoposide as first-line treatment for extensive-stage small-cell lung cancer (CAPSTONE-1): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2022 Jun;23(6):739-747. doi: 10.1016/S1470-2045(22)00224-8. Epub 2022 May 13.

  PMID: 35576956 RESULT

• Yin J, Yuan J, Li Y, Fang Y, Wang R, Jiao H, Tang H, Zhang S, Lin S, Su F, Gu J, Jiang T, Lin D, Huang Z, Du C, Wu K, Tan L, Zhou Q. Neoadjuvant adebrelimab in locally advanced resectable esophageal squamous cell carcinoma: a phase 1b trial. Nat Med. 2023 Aug;29(8):2068-2078. doi: 10.1038/s41591-023-02469-3. Epub 2023 Jul 24.

  PMID: 37488287 RESULT

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Shengxiang Ren, MD.

  Shanghai Pulmonary Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keyi Jia, MD.PHD.

CONTACT

+86 17621199707; jekyll_1206@163.com

Libo Luo, MD.Master.

CONTACT

+86 15087789662; luolibo@tongji.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 31, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 31, 2024

Record last verified: 2024-07