RecruitingPhase 2NCT07373964

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)

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


Sponsor

China Medical University, China

Enrollment

36 participants

Start Date

Oct 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a four-drug combination — chidamide (an epigenetic drug), a PD-L1 immunotherapy blocker, carboplatin (chemotherapy), and etoposide (chemotherapy) — as a first-line treatment for people with extensive-stage small-cell lung cancer (a fast-growing type of lung cancer that has spread widely). **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with extensive-stage small-cell lung cancer and have not received any prior treatment for it - You are in good physical condition (ECOG 0–1) - You have at least one measurable tumor lesion - Your organ function (blood counts, liver, kidneys, heart) meets required levels - You are willing to use effective contraception during and after treatment **You may NOT be eligible if...** - You have previously received an HDAC inhibitor or immunotherapy - You have another active cancer within the past 5 years (certain cured cancers may be acceptable) - You have HIV, immunodeficiency, or have had an organ transplant - You have uncontrolled heart disease or a prolonged QTc interval on ECG - You are pregnant or breastfeeding - You have a history of neurological or psychiatric disorders Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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.


Locations(1)

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

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NCT07373964


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