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This is a Phase II, single-arm, single-center study evaluating Chidamide combined with a PD-L1 inhibitor, carboplatin, and etoposide as first-line therapy in extensive-stage small-cell lung cancer (ES-SCLC) patients. The primary objective is to assess Progression-Free Survival (PFS) per RECIST v1.1. Secondary objectives include Objective Response Rate (ORR), Disease Control Rate (DCR), Duration of Response (DOR), Overall Survival (OS), and safety. Approximately 36 participants will receive induction therapy (Chidamide + chemotherapy + PD-L1 inhibitor) for 4 cycles, followed by Chidamide maintenance until progression or unacceptable toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chidamide Tabletsï¼› PD-L1 Inhibitor (as per chosen drug's prescribing information)ï¼›Carboplatinï¼› Etoposide | Drug | Induction Phase: Chidamide 15 mg orally on days 1, 4, 8, 11, 15, and 18 of each 21-day cycle for 4 cycles.PD-L1 inhibitor, carboplatin, and etoposide are administered per their respective prescribing information. Maintenance Phase: Chidamide 20 mg orally twice weekly (at least 3 days apart) until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.PD-L1 inhibitor is administered per their respective prescribing information. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) per RECIST v1.1 as assessed by the investigator. | baseline up to approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) per RECIST v1.1. | baseline up to approximately 24 months | |
| Disease Control Rate (DCR) per RECIST v1.1. | baseline up to approximately 24 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunpeng Liu | Contact | 13898865122 | cmuliuyunpeng@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of China Medical University | Recruiting | Shenyang | Liaoning | 110001 | China |
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|
| Duration of Response (DOR) per RECIST v1.1 |
| baseline up to approximately 24 months |
| Overall Survival (OS) | baseline up to approximately 24 months |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | baseline up to approximately 24 months |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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