VunakizumabPhase 2NCT07069270
A Study on the First-line Treatment of Small Cell Lung Cancer With Adebrelimab and Vunakizumab and Chemotherapy
A Phase 2 study testing Vunakizumab (IL-17A inhibitor), Adebrelimab and Chemotherapy in people with Vunakizumab and Adebrelimab, run by Fujian Cancer Hospital.
Trial summary
This study is a prospective, single-center, single-arm clinical trial, with a planned enrollment of 28 cases.The first Adebrelimab +Vunakizumab +EC was administered within 72 hours after enrollment for 4 to 6 cycles.At the end of the combination phase, non-PD subjects entered the maintenance treatment period of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Vunakizumab, Adebrelimab, Small Cell Lung Cancer
- What is being tested?
- Vunakizumab (IL-17A inhibitor), Adebrelimab and Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age: 18 to 75 years old, both male and female are acceptable.
- 2. Histologically or cytologically confirmed extensive-stage small cell Lung cancer (according to the Veterans Administration Lung Study Group, VALG staging);
- 3. No previous systematic treatment;
- 4. Life expectancy exceeds 3 months;
- 5.ECOG physical condition score: 0 to 1 point;
- 6. According to the RECIST 1.1 standard, the target lesion has at least one measurable diameter.
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- 7. Within one week before enrollment, the functions of important organs met the following criteria:
- blood routine: white blood cell count (WBC) ≥ 3.0 × 109/L; absolute neutrophil count (ANC) ≥ 1.5 × 109/L; platelet (PLT) ≥ 100 × 109/L; The hemoglobin content (HGB) is ≥ 9.0 g/Dl
- Liver function: aspartate transferase (AST) ≤ 2.5 × ULN, alanine aminotransferase (ALT) ≤ 2.5 × ULN For subjects with liver metastases, their ALT and AST levels were ≤ 5 × ULN. Serum total bilirubin (TBIL) ≤ 1.5 × ULN (except for Gilbert syndrome ≤ 3 × ULN); albumin (ALB) ≥ 30.0 g/L
- Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance rate (CrCl) ≥ 50 mL/minute (using the Cockcroft/Gault formula)
- Coagulation function: The international normalized ratio (INR) is ≤ 1.5, and the activated partial thromboplastin time (APTT) is ≤ 1.5 × ULN
- Others: Lipase ≤ 1.5 × ULN. If the lipase is greater than 1.5 × ULN and there is no clinical or radiological confirmation of pancreatitis, the patient can be enrolled. Amylase ≤ 1.5 × ULN. If the amylase is greater than 1.5 × ULN and there is no clinical or radiological confirmation of pancreatitis, the patient can be enrolled. alkaline phosphatase (ALP) ≤ 2.5 × ULN, for bone metastasis subjects, ALP ≤ 5 × ULN
- Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥ 50%;
- 8.Women of childbearing age must undergo a serum pregnancy study within 7 days before the first medication, and the result must be negative. Female subjects of childbearing age and male subjects whose partners are women of childbearing age must agree to contraception from the signing of the informed consent form until 24 weeks after the last administration of the study drug.
- 9. The subjects voluntarily joined this study, signed the informed consent form, had good compliance and cooperated with the follow-up.
Who cannot join
- 1. There is a large amount of uncontrolled pleural effusion, pericardial effusion or ascites;
- 2. The following heart disorders exist: (1) According to NYHA cardiac function classification, (1) Grade III-IV cardiac function; (2) Unstable angina pectoris or acute ischemia indicated by electrocardiogram or myocardial infarction occurred within one year; (3) Clinically significant supraventricular or ventricular arrhythmias and other conduction system abnormalities (including QTc interval ≥ 450ms in men and ≥470ms in women); (4) Clinically significant pericardial and myocardial diseases.
- 3. Insufficient bone marrow reserve or organ function;
- 4. Systemic immunomodulators (including but not limited to thymosin, interferon or interleukin-2) have been used for treatment within 4 weeks before enrollment;
- 5. Corticosteroid hormones (> 10 mg/ day prednisone or equivalent dose) or other immunosuppressants were used within 2 weeks before enrollment;
- 6. Have any active autoimmune diseases or a history of autoimmune diseases; Interstitial pneumonia, drug-induced pneumonia, radiation pneumonitis requiring steroid treatment, or active pneumonia with clinical symptoms;
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- 7. There was an active or uncontrolled severe infection (CTCAE 5.0 ≥ grade 2) within 2 weeks before enrollment, and/or received antibiotic treatment;
- 8. Tuberculosis patients who are active or undergoing treatment;
- 9. Uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg), history of hypertensive crisis or hypertensive encephalopathy;
- 10. Within 24 weeks before enrollment, there were hyperactive/venous thrombotic events, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.
- 11. Has undergone invasive surgery within 4 weeks before enrollment;
- 12. Positive for HBsAg and HBV DNA test value exceeding the upper limit of the normal reference value (1000 copies /mL or 100 IU/mL), or positive for HCV (HCV RNA or HCV Ab test indicating acute or chronic infection), or a history of HIV positivity;
- 13. Patients who have received live vaccines within 12 weeks before enrollment;
- 14. Known to be allergic to the research drug or excipients, and known to have a severe allergic reaction to any monoclonal antibody;
- 15. A known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- 16. Other malignant tumors concurrent within 5 years before enrollment are excluded, except for fully treatable cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, and ductal carcinoma in situ after radical resection.
- 17. It is known that there are serious mental disorders, alcoholism, drug abuse or drug abuse, etc.
- 18. Have received any other investigational drug treatment or participated in another interventional clinical study within 4 weeks prior to signing the ICF;
- 19. As determined by the researchers, the subjects have other factors that may lead to the forced termination of this study, such as non-compliance with the protocol, other serious diseases (including mental disorders) requiring concurrent treatment, severe laboratory test abnormalities, accompanied by family or social factors that may affect the safety of the subjects, or the collection of data and samples.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Single-center, Single-arm Clinical Study of Adebrelimab in Combination With Vunakizumab and Chemotherapy as First-line Treatment for Extensious-stage Small Cell Lung Cancer
This study is a prospective, single-center, single-arm clinical trial, with a planned enrollment of 28 cases.The first Adebrelimab +Vunakizumab +EC was administered within 72 hours after enrollment for 4 to 6 cycles.At the end of the combination phase, non-PD subjects entered the maintenance treatment period of Adebrelimab plus Vunakizumab.Treatment will continue until any of the following situations occur: disease progression in the subject, intolerable toxic and side effects, comorbidiments that affect further treatment, the investigator's decision to withdraw the subject from the study, or other reasons for non-compliance with the study treatment or the study procedures or protocols.
- Conditions
- Vunakizumab, Adebrelimab, Small Cell Lung Cancer
- Being tested
- Vunakizumab (IL-17A inhibitor), Adebrelimab, Chemotherapy
- Keywords
- Small cell lung cancer, Adebrelimab, Vunakizumab
- 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.
Vunakizumab (IL-17A inhibitor)Drug
Vunakizumab , 240mg, D1, subcutaneous injection, Q4W.
AdebrelimabDrug
Adebrelimab, 1200 mg, D1, intravenous drip, Q3W
ChemotherapyDrug
Etoposide, 100mg /m², D1-3, IV, Q3W. Carboplatin, AUC 5, D1, IV, Q3W
| Study group | Role | What they receive |
|---|---|---|
| Adebrelimab in combination with Vunakizumab and chemotherapy | Experimental | Not described Receives: Drug: Vunakizumab (IL-17A inhibitor); Drug: Adebrelimab; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-month PFS rate
Measured: 12-month
Secondary outcomes (5)
Progression-free survival (PFS）
Measured: 12- months
Overall survival (OS）
Measured: 24-months
Objective response rate (ORR）
Measured: Each 2 cycles can last up to 3 months (each cycle is 21 days).
Disease Control Rate (DCR）
Measured: Each 2 cycles can last up to 3 months (each cycle is 21 days).
The incidence and severity of adverse events (AE) and serious adverse events (SAE)
Measured: As long as two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VunakizumabStudies of the same condition, open and under way.
- More trials run by Fujian 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069270
- Sponsor's protocol ID
- K2025-218-01
- Status last verified
- Jul 2025
- First submitted
- 7 Jul 2025
- Last updated
- 16 Jul 2025
- 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 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Single-arm Clinical Study of Adebrelimab in Combination With Vunakizumab and Chemotherapy as First-line Treatment for Extensious-stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07069270
- Acronym / sponsor ID
- K2025-218-01
- Conditions
- Vunakizumab, Adebrelimab, Small Cell Lung Cancer
- Keywords
- Small cell lung cancer, Adebrelimab, Vunakizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 16 Jul 2025 (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 is a prospective, single-center, single-arm clinical trial, with a planned enrollment of 28 cases.The first Adebrelimab +Vunakizumab +EC was administered within 72 hours after enrollment for 4 to 6 cycles.At the end of the combination phase, non-PD subjects entered the maintenance treatment period of Adebrelimab plus Vunakizumab.Treatment will continue until any of the following situations occur: disease progression in the subject, intolerable toxic and side effects, comorbidiments that affect further treatment, the investigator's decision to withdraw the subject from the study, or other reasons for non-compliance with the study treatment or the study procedures or protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adebrelimab in combination with Vunakizumab and chemotherapy | Experimental | Drug: Vunakizumab (IL-17A inhibitor), Drug: Adebrelimab, Drug: Chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 1. Age: 18 to 75 years old, both male and female are acceptable.
- 2. Histologically or cytologically confirmed extensive-stage small cell Lung cancer (according to the Veterans Administration Lung Study Group, VALG staging);
- 3. No previous systematic treatment;
- 4. Life expectancy exceeds 3 months;
- 5.ECOG physical condition score: 0 to 1 point;
Key exclusion criteria (19 listed)
- 1. There is a large amount of uncontrolled pleural effusion, pericardial effusion or ascites;
- 2. The following heart disorders exist: (1) According to NYHA cardiac function classification, (1) Grade III-IV cardiac function; (2) Unstable angina pectoris or acute ischemia indicated by electrocardiogram or myocardial infarction occurred within one year; (3) Clinically significant supraventricular or ventricular arrhythmias and other conduction system abnormalities (including QTc interval ≥ 450ms in men and ≥470ms in women); (4) Clinically significant pericardial and myocardial diseases.
- 3. Insufficient bone marrow reserve or organ function;
- 4. Systemic immunomodulators (including but not limited to thymosin, interferon or interleukin-2) have been used for treatment within 4 weeks before enrollment;
- 5. Corticosteroid hormones (> 10 mg/ day prednisone or equivalent dose) or other immunosuppressants were used within 2 weeks before enrollment;
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 |
|---|---|---|
| Vunakizumab (IL-17A inhibitor)Vunakizumab , 240mg, D1, subcutaneous injection, Q4W. | Drug | Adebrelimab in combination with Vunakizumab and chemotherapy |
| AdebrelimabAdebrelimab, 1200 mg, D1, intravenous drip, Q3W | Drug | Adebrelimab in combination with Vunakizumab and chemotherapy |
| ChemotherapyEtoposide, 100mg /m², D1-3, IV, Q3W. Carboplatin, AUC 5, D1, IV, Q3W | Drug | Adebrelimab in combination with Vunakizumab and chemotherapy |
Primary outcome
12-month PFS rate
Time frame: 12-month
5 secondary outcomes
Progression-free survival (PFS）
Time frame: 12- months
Overall survival (OS）
Time frame: 24-months
Objective response rate (ORR）
Time frame: Each 2 cycles can last up to 3 months (each cycle is 21 days).
Disease Control Rate (DCR）
Time frame: Each 2 cycles can last up to 3 months (each cycle is 21 days).
The incidence and severity of adverse events (AE) and serious adverse events (SAE)
Time frame: As long as two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vunakizumab (IL-17A inhibitor), Adebrelimab and Chemotherapy in people with Vunakizumab and Adebrelimab, run by Fujian 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 15 inclusion and 19 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: opening soon, as of the sponsor's last update on 16 Jul 2025. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhiyong HE (13805086391, hezhiyongfjzlhospital@.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-month PFS rate (time frame: 12-month). 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 16 Jul 2025.