NCT07373964RecruitingPhase 2
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)
Source: ClinicalTrials.gov · Last updated 28 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 21 Jan 2026
- Start date
- 15 Oct 2025
- Primary completion date
- 14 Oct 2026
- Lead sponsor
- China Medical University, China
- Diseases
- Lung cancer
- NCT number
- NCT07373964
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 36
- From 15 Oct 2025 to the primary completion date, 14 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Factors significantly affecting oral drug absorption.
- Prior HDAC inhibitor or immune checkpoint inhibitor therapy.
Other illness
- Known allergy to any study drug component.
- Other malignancy within past 5 years (except certain cured cancers).
- Immunodeficiency, HIV positivity, or organ transplant history.
- Other severe comorbid conditions deemed unsafe by investigator.
- History of neurological or psychiatric disorders.
- Any condition making the patient unsuitable per investigator judgment.
Lab values
- Uncontrolled cardiovascular disease or QTc \>450 ms.
Other
- Participation in another clinical trial within 4 weeks.
- Pregnancy, lactation, or unwillingness to use effective contraception.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.