Small Cell Lung Cancer
Conditions
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.
Interventions
DRUGChidamide 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.
Sponsors
China Medical University, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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 0-1. * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) per RECIST v1.1 as assessed by the investigator. | baseline up to approximately 24 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Countries
China
Contacts
CONTACTYunpeng Liu
Outcome results
None listed