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Tests treatment safety and results for Small Cell Lung Cancer
Official title 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)
ClinicalTrials.gov ID: NCT07373964
What this study is testing
What is Chidamide Tablets； PD-L1 Inhibitor (as per chosen drug's prescribing information)；Carboplatin； Etoposide?
Chidamide Tablets； PD-L1 Inhibitor (as per chosen drug's prescribing information)；Carboplatin； Etoposide is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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.
You likely can't join 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shenyang, Liaoning, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenyang, Liaoning, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.