Extensive Stage Small Cell Lung CancerNCT06323265
A Real-world Study of Adebrelimab Combined With Chemotherapy±Chest Radiotherapy in Patients With Extensive Stage Small Cell Lung Cancer
An observational study of Extensive Stage Small Cell Lung Cancer, run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial summary
The purpose of this study is to assess efficacy and safety of patients who receive Adebrelimab combined with chemotherapy±chest radiotherapy as first-line treatment of extensive stage small cell lung cancer in the real world. 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
- What is being tested?
- Adebrelimab + chemotherapy and ±chest radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 26 Mar 2024to 1 Apr 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: extensive stage small cell lung cancer
Who may be able to join
- Age:≥18 years old;
- Patients with extensive stage small cell lung cancer confirmed by histopathology;
- Normal function of major organs;
- Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.
Who cannot join
- Patients with drug allergy sufferers;
- Serious and uncontrolled organic lesions or infections, such as decompensated heart, lung, kidney failure, etc;
- History of psychiatric drugs abuse and can't quit or patients with mental disorders;
- The researchers think inappropriate.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jun Wang
Shijiazhuang, Hebei
Jun Wang, 13931182128, wangjunzr@163.com
About this study
The purpose of this study is to assess efficacy and safety of patients who receive Adebrelimab combined with chemotherapy±chest radiotherapy as first-line treatment of extensive stage small cell lung cancer in the real world.
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Being tested
- Adebrelimab + chemotherapy, ±chest radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebrelimab + chemotherapyDrug
Adebrelimab: 1200mg, d1, iv (30-60min), Q3W ,up to progressive disease or toxicity intolerable Chemotherapy: etoposide 100mg/m2，d1-3，iv；carboplatin AUC=5-6，d1，iv；or cisplatin 75mg/m2，d1，iv，Q3W，4 cycles；
±chest radiotherapyRadiation
Chest radiotherapy: 3Gy/15f-18f or 2Gy/20f-25f
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Not described Receives: Drug: Adebrelimab + chemotherapy; Radiation: ±chest radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Baseline to measured date of progression or death from any cause
Measured: evaluated in 24 months since the treatment began
Secondary outcomes (5)
Objective response rate (ORR)
Baseline to measured stable disease
Measured: tumor assessment every 6 weeks since the treatment began，up to 24 months
Disease control rate (DCR)
Baseline to measured progressive disease
Measured: tumor assessment every 6 weeks since the treatment began，up to 24 months
Duration of Overall Response（DoR）
The duration of overall response is measured from the time that measurement criteria are met for complete response or partial response until the first date that recurrent or progressive disease is objectively documented
Measured: tumor assessment every 6 weeks since the treatment began，up to 24 months
Overall survival (OS)
Baseline to measured date of death from any cause
Measured: the first day of treatment to death or last survival confirm date,up to 24 months
Adverse events
Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. The number of Participants with adverse events will be recorded at each treatment visit
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start26 Mar 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive Stage Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Hebei Medical University Fourth HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun wang, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323265
- Sponsor's protocol ID
- ARL-SCLC-001
- Status last verified
- Mar 2024
- First submitted
- 14 Mar 2024
- Last updated
- 27 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study of Adebrelimab Combined With Chemotherapy±Chest Radiotherapy in Patients With Extensive Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06323265
- Acronym / sponsor ID
- ARL-SCLC-001
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 21 Mar 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 study is to assess efficacy and safety of patients who receive Adebrelimab combined with chemotherapy±chest radiotherapy as first-line treatment of extensive stage small cell lung cancer in the real world.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Drug: Adebrelimab + chemotherapy, Radiation: ±chest radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- extensive stage small cell lung cancer
Key inclusion criteria (4 listed)
- Age:≥18 years old;
- Patients with extensive stage small cell lung cancer confirmed by histopathology;
- Normal function of major organs;
- Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.
Key exclusion criteria (4 listed)
- Patients with drug allergy sufferers;
- Serious and uncontrolled organic lesions or infections, such as decompensated heart, lung, kidney failure, etc;
- History of psychiatric drugs abuse and can't quit or patients with mental disorders;
- The researchers think inappropriate.
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 |
|---|---|---|
| Adebrelimab + chemotherapyAdebrelimab: 1200mg, d1, iv (30-60min), Q3W ,up to progressive disease or toxicity intolerable Chemotherapy: etoposide 100mg/m2，d1-3，iv；carboplatin AUC=5-6，d1，iv；or cisplatin 75mg/m2，d1，iv，Q3W，4 cycles； | Drug | Experimental |
| ±chest radiotherapyChest radiotherapy: 3Gy/15f-18f or 2Gy/20f-25f | Radiation | Experimental |
Primary outcome
Progression free survival (PFS)
Time frame: evaluated in 24 months since the treatment began
Baseline to measured date of progression or death from any cause
5 secondary outcomes
Objective response rate (ORR)
Time frame: tumor assessment every 6 weeks since the treatment began，up to 24 months
Disease control rate (DCR)
Time frame: tumor assessment every 6 weeks since the treatment began，up to 24 months
Duration of Overall Response（DoR）
Time frame: tumor assessment every 6 weeks since the treatment began，up to 24 months
Overall survival (OS)
Time frame: the first day of treatment to death or last survival confirm date,up to 24 months
Adverse events
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
Related trials for Extensive Stage Small Cell Lung Cancer
Active, not recruitingPhase 3
Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab
Extensive-Stage Small-Cell Lung Cancer, Small-Cell Lung Cancer
RecruitingPhase 2
A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC
Extensive-stage Small-cell Lung Cancer
Active, not recruitingPhase 2
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer
RecruitingPhase 2
MOnaliZumab in Combination With durvAlumab (MEDI4736) for tRreatmenT of Small Cell Lung Cancer
Small Cell Lung Cancer, SCLC
Not yet recruitingPhase 2
Low-Dose Radiotherapy Plus Adebrelimab and Chemotherapy for Extensive-Stage Small Cell Lung Cancer
Small Cell Lung Cancer (SCLC), SCLC, Extensive Stage
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extensive Stage Small Cell Lung Cancer, run by Hebei Medical University Fourth Hospital at 1 site in 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 4 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 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: evaluated in 24 months since the treatment began). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2024.