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)

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 mainte

Trial Details

NCT ID

NCT07373964

Phase

PHASE2

Sponsor

China Medical University, China

Status

RECRUITING

Cancer Type

Lung Cancer

Interventions

• Chidamide Tablets； PD-L1 Inhibitor (as per chosen drug's prescribing information)；Carboplatin； Etoposide

Locations (sample)

• Shenyang, Liaoning, China|41.79222,123.43278

Key Eligibility Criteria

• 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.

For full eligibility, visit ClinicalTrials.gov.

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