A Multicenter Real-World Cohort Study of Adebrelimab Injection in the Treatment of Extensive-Stage Small Cell Lung Cancer
NCT ID: NCT06530797
Last Updated: 2024-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
2000 participants
OBSERVATIONAL
2024-08-01
2026-09-01
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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First-line treatment for advanced stage
Any first-line regiment including Adebrelimab for advanced stage ES-SCLC
First-line Adebrelimab regiment for advanced stage ES-SCLC
First-line Adebrelimab in any 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
Second-line and beyond Adebrelimab regiment for advanced stage ES-SCLC
Second-line and beyond Adebrelimab in any regiment for advanced stage ES-SCLC
Interventions
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First-line Adebrelimab regiment for advanced stage ES-SCLC
First-line Adebrelimab in any regiment for advanced stage ES-SCLC
Second-line and beyond Adebrelimab regiment for advanced stage ES-SCLC
Second-line and beyond Adebrelimab in any regiment for advanced stage ES-SCLC
Eligibility Criteria
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Inclusion Criteria
1. Voluntarily sign the informed consent form and agree to participate in the study.
2. Histopathologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).
3. Age ≥ 18 years.
4. Determined by the investigator to be eligible for Adebrelimab treatment.
Exclusion Criteria
1. Evidence of being a pregnant or lactating female.
2. Currently receiving treatment as part of a blinded study protocol.
3. Any other condition that the investigator deems unsuitable for inclusion in the study.
18 Years
ALL
No
Sponsors
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Shanghai Pulmonary Hospital, Shanghai, China
OTHER
Responsible Party
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Ren Shengxiang
Prof.
Principal Investigators
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Shengxiang Ren, MD.
Role: PRINCIPAL_INVESTIGATOR
Shanghai Pulmonary Hospital, Shanghai, China
Central Contacts
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References
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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.
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.
Other Identifiers
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OBU-SH-SCLC-RWS-001
Identifier Type: -
Identifier Source: org_study_id