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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Chidamide Tablets； PD-L1 Inhibitor (as per chosen drug's prescribing information)；Carboplatin； Etoposide.
- Who it may be relevant to
- Registry conditions: Small Cell Lung Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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)
Overview
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.
Interventions
- Drug Chidamide Tablets； PD-L1 Inhibitor (as per chosen drug's prescribing information)；Carboplatin； Etoposide
Induction Phase: Chidamide 15 mg orally on days 1, 4, 8, 11, 15, and 18 of each 21-day cycle for 4 cycles.PD-L1 inhibitor, carboplatin, and etoposide are administered per their respective prescribing information. Maintenance Phase: Chidamide 20 mg orally twice weekly (at least 3 days apart) until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.PD-L1 inhibitor is administered per their respective prescribing information.
Primary outcome measures
- Progression-Free Survival (PFS) per RECIST v1.1 as assessed by the investigator. [Time frame: baseline up to approximately 24 months]
Secondary outcome measures (5)
- Objective Response Rate (ORR) per RECIST v1.1. [Time frame: baseline up to approximately 24 months]
- Disease Control Rate (DCR) per RECIST v1.1. [Time frame: baseline up to approximately 24 months]
- Duration of Response (DOR) per RECIST v1.1 [Time frame: baseline up to approximately 24 months]
- Overall Survival (OS) [Time frame: baseline up to approximately 24 months]
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Time frame: baseline up to approximately 24 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of China Medical University — Shenyang
Identifiers
NCT: NCT07373964 · CSIIT-Q115