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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Yunpeng Liu
• Email: cmuliuyunpeng@hotmail.com
• Phone: 13898865122

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cirtuvivint plus irinotecan for relapsed small-cell lung cancer

  This trial will test whether adding cirtuvivint to irinotecan helps people with relapsed small-cell lung cancer respond better and live longer.

  Recruiting Phase 1/2 Washington University School of Medicine · St Louis, Missouri · NCT07155200

• Tarlatamab in strong-performance-status small-cell lung cancer

  This trial tests whether tarlatamab can help people with extensive-stage small-cell lung cancer and poor health (ECOG 2) who have already had prior treatment.

  Recruiting at 8 sites Phase 2 AIO-Studien-gGmbH · Berlin and 7 other locations · NCT07803848

• Armored DLL3-SAVVYZ-IL18 CAR T cells for DLL3+ cancers

  Aims to see if DLL3-SAVVYZ-IL18 CAR T cells can be safely given to people with DLL3-positive cancers, including certain small cell lung cancers and other neuroendocrine tumors.

  Recruiting at 7 sites Phase 1 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07783477

• Tarlatamab given under the skin vs by IV in extensive-stage small cell lung cancer after platinum therapy

  This trial tests whether subcutaneous tarlatamab works as well as the IV form for people with extensive-stage small cell lung cancer after platinum chemotherapy.

  Recruiting at 9 sites Phase 3 Amgen · Orlando, Florida and 8 other locations · NCT07778316

• NK Cells Plus Immunotherapy for Extensive-Stage Small Cell Lung Cancer Maintenance

  This study tests whether adding allogeneic NK cell therapy to standard immunotherapy helps people with extensive-stage small cell lung cancer who have disease control after initial chemotherapy and immunotherapy.

  Recruiting Phase 2 Tianjin First Central Hospital · Tianjin, Tianjin Municipality · NCT07759856

• BL-M14D1 plus atezolizumab vs standard therapy in first-line extensive-stage small cell lung cancer

  A first-line treatment for adults with extensive-stage small cell lung cancer tests whether adding BL-M14D1 to atezolizumab and standard chemotherapy helps more than standard care.

  Recruiting at 7 sites Phase 3 SystImmune Inc. · Springdale, Arkansas and 61 other locations · NCT07625644

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.