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

ConditionExtensive-stage Small Cell Lung Cancer (ES-SCLC)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai Pulmonary Hospital, Shanghai, China

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Evidence of being a pregnant or lactating female.

Currently receiving treatment as part of a blinded study protocol.

Any other condition that the investigator deems unsuitable for inclusion in the study.

Trial 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%.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

    Drug

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

  • 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

Treatment groups

2,000 Participants
are divided into 2 treatment groups
Group A: First-line treatment for advanced stage1 intervention
Group B: Second-line and beyond for advanced stage1 intervention

Trial outcomes

Primary outcomes

1

Safety (The occurrence of ≥3 grade AEs)

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

Secondary outcomes

1

PFS

Progression free survival from Adebrelimab treatment

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

OS

Overall survival from Adebrelimab treatment

Time frame
Up to 2 years. From date of enrollment until the date of death from any cause, assessed up to 2 years.
3

DoR

Duration of response of Adebrelimab treatment

Time frame
Up to 2 years. From date of enrollment until the date of first documented progression, assessed up to 2 years.
4

ORR

Objective response rate of Adebrelimab treatment

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Pulmonary Hospital, Shanghai, China

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: