Extensive-stage Small Cell Lung Cancer (ES-SCLC)NCT06530797
A Multicenter Real-World Cohort Study of Adebrelimab Injection in the Treatment of Extensive-Stage Small Cell Lung Cancer
An observational study of Extensive-stage Small Cell Lung Cancer (ES-SCLC), run by Shanghai Pulmonary Hospital, Shanghai, China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive-stage Small Cell Lung Cancer (ES-SCLC)
- What is being tested?
- First-line Adebrelimab regiment for advanced stage ES-SCLC and Second-line and beyond Adebrelimab regiment for advanced stage ES-SCLC
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 1 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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%.
Who may be able to join
- Patients must meet all of the following criteria to be eligible for inclusion in this study:
- 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.
Who cannot join
- Patients with any of the following conditions are not eligible for inclusion in this study:
- 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 locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Being tested
- First-line Adebrelimab regiment for advanced stage ES-SCLC, Second-line and beyond Adebrelimab regiment for advanced stage ES-SCLC
- Keywords
- Extensive-stage small cell lung cancer (ES-SCLC), Adebrelimab
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First-line Adebrelimab regiment for advanced stage ES-SCLCDrug
First-line Adebrelimab in any regiment for advanced stage ES-SCLC
Second-line and beyond Adebrelimab regiment for advanced stage ES-SCLCDrug
Second-line and beyond Adebrelimab in any regiment for advanced stage ES-SCLC
| Study group | Role | What they receive |
|---|---|---|
| First-line treatment for advanced stage | Any first-line regiment including Adebrelimab for advanced stage ES-SCLC Receives: Drug: First-line Adebrelimab 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 Receives: Drug: Second-line and beyond Adebrelimab regiment for advanced stage ES-SCLC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (The occurrence of ≥3 grade AEs)
The occurrence of ≥3 grade AEs
Measured: From August 2024, patients will be followed up for 90 days after the last use of Adebrelimab
Secondary outcomes (5)
PFS
Progression free survival from Adebrelimab treatment
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 2 years. From date of enrollment until the date of first documented progression, assessed up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Extensive-stage Small Cell Lung Cancer (ES-SCLC)Studies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ren Shengxiang, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Shengxiang Ren, MD., Principal investigator, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530797
- Sponsor's protocol ID
- OBU-SH-SCLC-RWS-001
- Status last verified
- Jul 2024
- First submitted
- 19 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Publications
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.
PubMed 35576956Yin 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.
PubMed 37488287
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Real-World Cohort Study of Adebrelimab Injection in the Treatment of Extensive-Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06530797
- Acronym / sponsor ID
- OBU-SH-SCLC-RWS-001
- Keywords
- Extensive-stage small cell lung cancer (ES-SCLC), Adebrelimab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First-line treatment for advanced stage | – | Drug: First-line Adebrelimab regiment for advanced stage ES-SCLCAny first-line regiment including Adebrelimab for advanced stage ES-SCLC |
| Second-line and beyond for advanced stage | – | Drug: Second-line and beyond Adebrelimab regiment for advanced stage ES-SCLCAny Second- or later-line and regiment including Adebrelimab for advanced stage ES-SCLC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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%.
Key inclusion criteria (5 listed)
- Patients must meet all of the following criteria to be eligible for inclusion in this study:
Key exclusion criteria (4 listed)
- Patients with any of the following conditions are not eligible for inclusion in this study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| First-line Adebrelimab regiment for advanced stage ES-SCLCFirst-line Adebrelimab in any regiment for advanced stage ES-SCLC | Drug | First-line treatment for advanced stage |
| Second-line and beyond Adebrelimab regiment for advanced stage ES-SCLCSecond-line and beyond Adebrelimab in any regiment for advanced stage ES-SCLC | Drug | Second-line and beyond for advanced stage |
Primary outcome
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
5 secondary outcomes
PFS
Time frame: 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.
DoR
Time frame: 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.
DCR
Time frame: Up to 2 years. From date of enrollment until the date of first documented progression, assessed up to 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Results publication: PubMed 35576956Wang 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.
- Results publication: PubMed 37488287Yin 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.
- Individual participant dataSharing planned: Undecided. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shengxiang Ren, MD. principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
Questions about this trial
What is this clinical trial studying?
An observational study of Extensive-stage Small Cell Lung Cancer (ES-SCLC), run by Shanghai Pulmonary Hospital, Shanghai, China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keyi Jia, MD.PHD. (+86 17621199707, jekyll_1206@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06530797, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.