Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06530797
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
A Multicenter Real-World Cohort Study of Adebrelimab Injection in the Treatment of Extensive-Stage Small Cell Lung Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Real-World Cohort Study of Adebrelimab Injection in the Treatment of Extensive-Stage Small Cell Lung Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 consentvoluntary withdrawal or study terminationclosure 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 eventsserious 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
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 consentvoluntary withdrawal or study terminationclosure 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 eventsserious 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None