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)

January 21, 2026 updated by: Yunpeng Liu, China Medical University, China

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • Recruiting
        • The First Affiliated Hospital of China Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).
  • Signed informed consent.

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.
  • Any condition making the patient unsuitable per investigator judgment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment group
Drug: Chidamide 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-Free Survival (PFS) per RECIST v1.1 as assessed by the investigator.
Time Frame: baseline up to approximately 24 months
baseline up to approximately 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate (ORR) per RECIST v1.1.
Time Frame: baseline up to approximately 24 months
baseline up to approximately 24 months
Disease Control Rate (DCR) per RECIST v1.1.
Time Frame: baseline up to approximately 24 months
baseline up to approximately 24 months
Duration of Response (DOR) per RECIST v1.1
Time Frame: baseline up to approximately 24 months
baseline up to approximately 24 months
Overall Survival (OS)
Time Frame: baseline up to approximately 24 months
baseline up to approximately 24 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: baseline up to approximately 24 months
baseline up to approximately 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2025

Primary Completion (Estimated)

October 14, 2026

Study Completion (Estimated)

October 14, 2027

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSIIT-Q115

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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