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A Prospective, Single-Arm, Single-Center Phase II Study Evaluating the Efficacy and Safety of Chidamide Combined With PD-L1 Inhibitor, Carboplatin, and Etoposide as First-Line Treatment in Patients With Extensive-Stage Small-Cell Lung Cancer (ES-SCLC)

StatusRecruiting
PhasePhase 2
Started2025-10-15
View on ClinicalTrials.gov ↗
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.
Trial Details
NCT Number NCT07373964
Lead Sponsor China Medical University, China
Conditions Small Cell Lung Cancer
Enrollment 36 participants
Start Date 2025-10-15
Primary Completion 2026-10-14 (estimated)
Study Completion 2027-10-14 (estimated)
Updated on ClinicalTrials.gov 2026-01-28