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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adebrelimab in combination with Vunakizumab and chemotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vunakizumab (IL-17A inhibitor) | Drug | Vunakizumab , 240mg, D1, subcutaneous injection, Q4W. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 12-month PFS rate | 12-month |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | 12- months | |
| Overall survival (OS) | 24-months | |
| Objective response rate (ORR) |
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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:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhiyong HE | Contact | 13805086391 | hezhiyongfjzlhospital@.com |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Adebrelimab | Drug | Adebrelimab, 1200 mg, D1, intravenous drip, Q3W |
|
| Chemotherapy | Drug | Etoposide, 100mg /m², D1-3, IV, Q3W. Carboplatin, AUC 5, D1, IV, Q3W |
|
| Each 2 cycles can last up to 3 months (each cycle is 21 days). |
| Disease Control Rate (DCR) | 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) | As long as two years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |