Extensive-stage Small-cell Lung CancerNCT05991180
Real-World Study on the Efficacy of IBI-322 in Combination With Lenvatinib for the Treatment of Extensive Stage Small Cell Lung Cancer
An observational study of Extensive-stage Small-cell Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.
Trial summary
This is a descriptive observational study, in which data are collected in an epidemiological fashion and prospective. This study does not intend to intervene the current medical practice of the recruited 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
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2023to 31 Dec 2025
- 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
- Patients must be ≥18 years.
- Provision of fully informed consent prior to any study specific procedures.
- Patients with extensive stage SCLC diagnosed by pathology (as staged by the American Veterans Lung Cancer Association (VALG)), who do not have an imaging response during first-line treatment with PD-(L)1 inhibitors, or who progress after imaging reactions on first-line therapy (the most recent regimen prior to enrollment must contain PD-(L)1 inhibitors).
- According to the RECIST 1.1 standard, the patient must have at least one measurable lesion.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hunan Cancer hospital
Changsha, Hunan
Yongchang Zhang, MD, +86 731 89762321, zhangyongchang@csu.edu.cn
About this study
Official title: Real-World Study on the Efficacy of IBI-322 in Combination With Lenvatinib for the Treatment of Extensive Stage Small Cell Lung Cancer and Assessment of Biomarkers
This is a descriptive observational study, in which data are collected in an epidemiological fashion and prospective. This study does not intend to intervene the current medical practice of the recruited patients.
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Medical subject headings
- Small Cell Lung Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects
Measured: 2 years
Secondary outcomes (2)
PFS
Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)
Measured: 2 years
OS
Defined as the time from the start of treatment to the death of the subject due to any cause.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start25 Dec 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Dec 2025 (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.
- 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Province Tumor Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongchang Zhang, Hunan Province Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991180
- Sponsor's protocol ID
- BELIEVE RWS
- Status last verified
- Dec 2023
- First submitted
- 6 Aug 2023
- Last updated
- 27 Dec 2023
- 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 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Study on the Efficacy of IBI-322 in Combination With Lenvatinib for the Treatment of Extensive Stage Small Cell Lung Cancer and Assessment of Biomarkers
- ClinicalTrials.gov ID
- NCT05991180
- Acronym / sponsor ID
- BELIEVE RWS
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Hunan Province Tumor HospitalUniversity, hospital or other
- Study start
- 25 Dec 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Aug 2023 (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 is a descriptive observational study, in which data are collected in an epidemiological fashion and prospective. This study does not intend to intervene the current medical practice of the recruited patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
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)
- Patients must be ≥18 years.
- Provision of fully informed consent prior to any study specific procedures.
- Patients with extensive stage SCLC diagnosed by pathology (as staged by the American Veterans Lung Cancer Association (VALG)), who do not have an imaging response during first-line treatment with PD-(L)1 inhibitors, or who progress after imaging reactions on first-line therapy (the most recent regimen prior to enrollment must contain PD-(L)1 inhibitors).
- According to the RECIST 1.1 standard, the patient must have at least one measurable lesion.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ORR
Time frame: 2 years
Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects
2 secondary outcomes
PFS
Time frame: 2 years
OS
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
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 Hunan Province Tumor 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 1 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 Dec 2023. 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?
Contact Yongchang Zhang, MD (+8613873123436, zhangyongchang@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 2 years). 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 Dec 2023.