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
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Progression-Free Survival (PFS) per RECIST v1.1 as assessed by the investigator.
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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-
- •At least one measurable lesion per RECIST v1.
- •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).
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.
Arms & Interventions
treatment group
Intervention: Chidamide Tablets； PD-L1 Inhibitor (as per chosen drug's prescribing information)；Carboplatin； Etoposide (Drug)
Outcomes
Primary Outcomes
Progression-Free Survival (PFS) per RECIST v1.1 as assessed by the investigator.
Time Frame: baseline up to approximately 24 months
Secondary Outcomes
- Objective Response Rate (ORR) per RECIST v1.1.(baseline up to approximately 24 months)
- Disease Control Rate (DCR) per RECIST v1.1.(baseline up to approximately 24 months)
- Duration of Response (DOR) per RECIST v1.1(baseline up to approximately 24 months)
- Overall Survival (OS)(baseline up to approximately 24 months)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](baseline up to approximately 24 months)
Investigators
Yunpeng Liu
professor
China Medical University, China