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.
Age ≥18 and ≤75 years.
Histologically confirmed ES-SCLC, unsuitable for local radical therapy.
No prior systemic therapy for ES-SCLC.
ECOG performance status 0-1.
Factors significantly affecting oral drug absorption.
Prior HDAC inhibitor or immune checkpoint inhibitor therapy.
Known allergy to any study drug component.
Other malignancy within past 5 years (except certain cured cancers).
Single group
Chidamide Tablets； PD-L1 Inhibitor (as per chosen drug's prescribing information)；Carboplatin； Etoposide
DrugInduction 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.
Progression-Free Survival (PFS) per RECIST v1.1 as assessed by the investigator.
Objective Response Rate (ORR) per RECIST v1.1.
Disease Control Rate (DCR) per RECIST v1.1.
Duration of Response (DOR) per RECIST v1.1
Overall Survival (OS)
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