SCLC,Extensive StageSCLCNCT06267170
A Multicenter, Real-world Study of Adebrelimab in the Treatment of Extensive Stage Small Cell Lung Cancer
An observational study of SCLC,Extensive Stage, run by Henan Cancer Hospital.
Trial summary
This study collected data on patients with extensive stage small cell lung cancer treated with Adebrelimab to investigate its safety and efficacy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SCLC,Extensive Stage
- What is being tested?
- Adebrelimab
- How many people
- 288 participants
- Where
- No sites listed yet
- Study dates
- 25 Feb 2024to 25 Feb 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with extensive stage small cell lung cancer treated with adebrelimab
Who may be able to join
- Sign informed consent and join the study voluntarily;
- Patients diagnosed with extensive small cell lung cancer;
- Age ≥18 years old;
- Have at least one measurable lesion (according to RECIST 1.1);
- The investigators judged that adebrelimab treatment was acceptable;
- Contraception: Patients should agree that it must be used during the study period and within 6 months after the study ends Effective contraception;
Who cannot join
- Allergic to adebrelimab and its excipients;
- Patients who have also received other immune drugs or therapies;
- Patients who are participating in other interventional studies;
- patients with other malignant tumors;
- Pregnant or lactating women;
- The investigator considers that the patient is not suitable to participate in any other conditions of the study.
About this study
Official title: A Multicenter, Real-world Study of Adebrelimab in the Treatment of Extensive Stage
This study collected data on patients with extensive stage small cell lung cancer treated with Adebrelimab to investigate its safety and efficacy
- Conditions
- SCLC,Extensive Stage
- Being tested
- Adebrelimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdebrelimabDrug
Treatment with adbelizumab
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (Occurrence of ≥ Grade 3 AE)
The incidence of grade 3 or higher adverse events
Measured: End of each cycle (each cycle is 28 days)
Secondary outcomes (4)
PFS
Progression free survival
Measured: End of every two cycles (each cycle is 28 days)
ORR
Objective response rate
Measured: End of every two cycles (each cycle is 28 days)
OS
Overall survival
Measured: End of every two cycles (each cycle is 28 days)
DCR
Disease control rate
Measured: End of every two cycles (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start25 Feb 2024 (estimated)
- Primary completion25 Feb 2025 (estimated)
- Study completion25 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCLC,Extensive StageStudies of the same condition, open and under way.
- More trials run by Henan Cancer 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
- Other
- Time perspective
- Prospective
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Qiming Wang, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267170
- Sponsor's protocol ID
- SCLC-RWS-001
- Acronym
- SCLC
- Status last verified
- Feb 2024
- First submitted
- 30 Jan 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Real-world Study of Adebrelimab in the Treatment of Extensive Stage
- ClinicalTrials.gov ID
- NCT06267170
- Acronym / sponsor ID
- SCLC / SCLC-RWS-001
- Conditions
- SCLC,Extensive Stage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 25 Feb 2024 (estimated)
- Primary completion
- 25 Feb 2025 (estimated)
- Study completion
- 25 Feb 2026 (estimated)
- First posted
- 20 Feb 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.
This study collected data on patients with extensive stage small cell lung cancer treated with Adebrelimab to investigate its safety and efficacy
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with extensive stage small cell lung cancer treated with adebrelimab
Key inclusion criteria (6 listed)
- Sign informed consent and join the study voluntarily;
- Patients diagnosed with extensive small cell lung cancer;
- Age ≥18 years old;
- Have at least one measurable lesion (according to RECIST 1.1);
- The investigators judged that adebrelimab treatment was acceptable;
Key exclusion criteria (6 listed)
- Allergic to adebrelimab and its excipients;
- Patients who have also received other immune drugs or therapies;
- Patients who are participating in other interventional studies;
- patients with other malignant tumors;
- Pregnant or lactating women;
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 |
|---|---|---|
| AdebrelimabTreatment with adbelizumab | Drug | – |
Primary outcome
Safety (Occurrence of ≥ Grade 3 AE)
Time frame: End of each cycle (each cycle is 28 days)
The incidence of grade 3 or higher adverse events
4 secondary outcomes
PFS
Time frame: End of every two cycles (each cycle is 28 days)
ORR
Time frame: End of every two cycles (each cycle is 28 days)
OS
Time frame: End of every two cycles (each cycle is 28 days)
DCR
Time frame: End of every two cycles (each cycle is 28 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of SCLC,Extensive Stage, run by Henan Cancer Hospital.
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 6 inclusion and 6 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 20 Feb 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (Occurrence of ≥ Grade 3 AE) (time frame: End of each cycle (each cycle is 28 days)). 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 20 Feb 2024.