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A Study on the First-line Treatment of Small Cell Lung Cancer With Adebrelimab and Vunakizumab and Chemotherapy | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

A Study on the First-line Treatment of Small Cell Lung Cancer With Adebrelimab and Vunakizumab and Chemotherapy

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

NCT07069270•Fujian Cancer Hospital

View on ClinicalTrials.gov

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 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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•7\. Within one week before enrollment, the functions of important organs met the following criteria:
•1. 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
•2. 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
•3. Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance rate (CrCl) ≥ 50 mL/minute (using the Cockcroft/Gault formula)
+5 more criteria

Exclusion Criteria

•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;
•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.
+9 more criteria

Key Dates

Start Date

September 1, 2025

Primary Completion Date

June 1, 2026

Completion Date

January 1, 2028

Last Updated

July 16, 2025

Enrollment

ESTIMATED participants

Conditions

VunakizumabAdebrelimabSmall Cell Lung Cancer

Interventions

Vunakizumab (IL-17A inhibitor)

DRUG

Adebrelimab

DRUG

Chemotherapy

DRUG

Contacts

Zhiyong HE

CONTACT

13805086391 hezhiyongfjzlhospital@.com

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Brain MetastasesNonsmall Cell Lung Cancer Stage III

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Non-small Cell Lung Cancer (NSCLC)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study on the First-line Treatment of Small Cell Lung Cancer With Adebrelimab and Vunakizumab and Chemotherapy

Inclusion Criteria

Exclusion Criteria

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