Clinical trial · Interventional
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)
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chidamide Tablets; PD-L1 Inhibitor (as per chosen drug's prescribing information);Carboplatin; Etoposide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment group
- interventionNames
- Drug: Chidamide Tablets; PD-L1 Inhibitor (as per chosen drug's prescribing information);Carboplatin; Etoposide
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS) per RECIST v1.1 as assessed by the investigator.
- timeFrame
- baseline up to approximately 24 months
Secondary outcomes (5)
- measure
- Objective Response Rate (ORR) per RECIST v1.1.
- timeFrame
- baseline up to approximately 24 months
- measure
- Disease Control Rate (DCR) per RECIST v1.1.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available