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Study identifier: NCT07373964 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: Recruiting

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)

Condition: Small Cell Lung Cancer  ·  Sponsor: China Medical University, China

PhasePhase 2
Planned participants36
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNoCheck eligibility criteria ↓
WhereShenyang, Liaoning, China

Interested? Contact the study team ↓

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Yunpeng Liu  ·  13898865122  ·  cmuliuyunpeng@hotmail.com

There is no obligation to join — the study team can answer your questions about taking part.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (1)

The First Affiliated Hospital of China Medical UniversityShenyang, Liaoning, ChinaRecruiting

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