Chidamide plus PD-L1 inhibitor with carboplatin and etoposide for first-line extensive-stage small‑cell lung cancer

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 trial will test whether adding chidamide to a PD-L1 inhibitor together with carboplatin and etoposide helps people with extensive-stage small‑cell lung cancer stay progression‑free longer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: China Medical University, China (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shenyang, Liaoning)
• Trial ID: NCT07373964 on ClinicalTrials.gov

What this trial studies

This is a single-center, single‑arm Phase II study enrolling about 36 patients with previously untreated extensive‑stage small‑cell lung cancer. Participants receive four cycles of induction therapy combining oral chidamide with a PD‑L1 inhibitor, carboplatin, and etoposide, followed by chidamide maintenance until disease progression or unacceptable toxicity. The primary endpoint is progression‑free survival measured by RECIST v1.1, and secondary endpoints include objective response rate, disease control rate, duration of response, overall survival, and safety. Eligible patients must be 18–75 years old with ECOG 0–1, measurable disease, and adequate organ function.

Who should consider this trial

Good fit: Ideal candidates are adults (18–75) with histologically confirmed extensive‑stage SCLC, no prior systemic therapy for ES‑SCLC, ECOG performance status 0–1, measurable disease, and adequate organ function.

Not a fit: Patients who previously received HDAC inhibitors or immune checkpoint inhibitors, those with poor performance status, active uncontrolled infections or severe organ dysfunction, or recent other malignancies are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the combination could prolong time without disease progression and potentially improve overall survival as a new first‑line option for ES‑SCLC.

How similar studies have performed: PD‑L1 inhibitors combined with platinum‑etoposide have improved outcomes in ES‑SCLC, but adding an HDAC inhibitor like chidamide is largely investigational and has limited prior clinical evidence.

Eligibility criteria

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.

Where this trial is running

Shenyang, Liaoning

• The First Affiliated Hospital of China Medical University — Shenyang, Liaoning, China (RECRUITING)

Study contacts

• Study coordinator: Yunpeng Liu

Conditions: Small Cell Lung Cancer