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RECRUITINGPHASE2

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)

NCT07373964•China Medical University, China

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion 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.
•At least one measurable lesion per RECIST v1.1.
•Expected survival ≥3 months.
•Adequate organ function (hematological, hepatic, renal, cardiac).
•Effective contraception from consent until 180 days after last dose.
•For active HBV infection: HBV DNA \<2000 IU/mL within 28 days before treatment and on stable antiviral therapy.
•Recovery from prior therapy toxicities to ≤ Grade 1 (except alopecia).
+1 more criteria

Exclusion Criteria

•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).
•Participation in another clinical trial within 4 weeks.
•Immunodeficiency, HIV positivity, or organ transplant history.
•Uncontrolled cardiovascular disease or QTc \>450 ms.
•Pregnancy, lactation, or unwillingness to use effective contraception.
•Other severe comorbid conditions deemed unsafe by investigator.
•History of neurological or psychiatric disorders.
+1 more criteria

Locations (1)

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Key Dates

Start Date

October 15, 2025

Primary Completion Date

October 14, 2026

Completion Date

October 14, 2027

Last Updated

January 28, 2026

Enrollment

ESTIMATED participants

Conditions

Small Cell Lung Cancer

Interventions

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

DRUG

Contacts

Yunpeng Liu

CONTACT

13898865122 cmuliuyunpeng@hotmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

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