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

July 26, 2024 updated by: Ren Shengxiang, Shanghai Pulmonary Hospital, Shanghai, China
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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%.

Description

Inclusion Criteria:

  • Patients must meet all of the following criteria to be eligible for inclusion in this study:

    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:

  • Patients with any of the following conditions are not eligible for inclusion in this study:

    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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety (The occurrence of ≥3 grade AEs)
Time Frame: From August 2024, patients will be followed up for 90 days after the last use of Adebrelimab
The occurrence of ≥3 grade AEs
From August 2024, patients will be followed up for 90 days after the last use of Adebrelimab

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: Up to 2 years. From date of enrollment until the date of first documented progression, assessed up to 2 years.
Progression free survival from Adebrelimab treatment
Up to 2 years. From date of enrollment until the date of first documented progression, assessed up to 2 years.
OS
Time Frame: Up to 2 years. From date of enrollment until the date of death from any cause, assessed up to 2 years.
Overall survival from Adebrelimab treatment
Up to 2 years. From date of enrollment until the date of death from any cause, assessed up to 2 years.
DoR
Time Frame: Up to 2 years. From date of enrollment until the date of first documented progression, assessed up to 2 years.
Duration of response of Adebrelimab treatment
Up to 2 years. From date of enrollment until the date of first documented progression, assessed up to 2 years.
ORR
Time Frame: Up to 2 years. From date of enrollment until the date of first documented progression, assessed up to 2 years.
Objective response rate of Adebrelimab treatment
Up to 2 years. From date of enrollment until the date of first documented progression, assessed up to 2 years.
DCR
Time Frame: Up to 2 years. From date of enrollment until the date of first documented progression, assessed up to 2 years.
Disease control rate of Adebrelimab treatment
Up to 2 years. From date of enrollment until the date of first documented progression, assessed up to 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Investigators

  • Principal Investigator: Shengxiang Ren, MD., Shanghai Pulmonary Hospital, Shanghai, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

July 19, 2024

First Submitted That Met QC Criteria

July 26, 2024

First Posted (Actual)

July 31, 2024

Study Record Updates

Last Update Posted (Actual)

July 31, 2024

Last Update Submitted That Met QC Criteria

July 26, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBU-SH-SCLC-RWS-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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