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)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChina Medical University, China

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

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

Treatment groups

36 Participants
are divided into 1 treatment group