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)

NCT07373964 | Recruiting Phase 2

• 1 other identifier: CSIIT-Q115
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS) per RECIST v1.1 as assessed by the investigator.

  baseline up to approximately 24 months

Secondary Outcomes (5)

• Objective Response Rate (ORR) per RECIST v1.1.

  baseline up to approximately 24 months

• Disease Control Rate (DCR) per RECIST v1.1.

  baseline up to approximately 24 months

• Duration of Response (DOR) per RECIST v1.1

  baseline up to approximately 24 months

• Overall Survival (OS)

  baseline up to approximately 24 months

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  baseline up to approximately 24 months

Study Arms (1)

treatment group

EXPERIMENTAL

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

Interventions

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

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.

treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (1)

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110001, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Yunpeng Liu

CONTACT

13898865122; cmuliuyunpeng@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 28, 2026
• Study Start: October 15, 2025
• Primary Completion (Estimated): October 14, 2026
• Study Completion (Estimated): October 14, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

CN (1)