An observational study in Extensive-stage Small Cell Lung Cancer (ES-SCLC), sponsored by Shanghai Pulmonary Hospital, Shanghai, China. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-31.
Sponsored by Shanghai Pulmonary Hospital, Shanghai, China · Observational
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.
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.
1,234 studies on the registry are indexed under Small Cell Lung Carcinoma; 350 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 150 across 124 observational studies indexed under Small Cell Lung Carcinoma.
Browse Small Cell Lung Carcinoma studies →Shanghai Pulmonary Hospital, Shanghai, China is the lead sponsor of 157 studies on the registry; 94 are open to participants now.
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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%.
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Patients must meet all of the following criteria to be eligible for inclusion in this study:
Exclusion Criteria:
Patients with any of the following conditions are not eligible for inclusion in this study:
Any first-line regiment including Adebrelimab for advanced stage ES-SCLC
Drug: First-line Adebrelimab regiment for advanced stage ES-SCLC
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
First-line Adebrelimab in any regiment for advanced stage ES-SCLC
Second-line and beyond Adebrelimab in any regiment for advanced stage ES-SCLC
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
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.
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.
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.
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.
DCR
Disease control 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.
No study locations are listed for this record.
Plan to share: Undecided — Undecided
This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Shanghai Pulmonary Hospital, Shanghai, China →