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OncoMatch/Clinical Trials/NCT07373964

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)

Is NCT07373964 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Chidamide Tablets; PD-L1 Inhibitor (as per chosen drug's prescribing information);Carboplatin; Etoposide for small cell lung cancer.

Phase 2RecruitingChina Medical University, ChinaNCT07373964Data as of Jun 2026Location: China

Treatment: Chidamide Tablets; PD-L1 Inhibitor (as per chosen drug's prescribing information);Carboplatin; EtoposideThis 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.

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Extracted eligibility criteria

Treatments studied

Chemotherapy

Chidamide Tablets; PD-L1 Inhibitor (as per chosen drug's prescribing information);Carboplatin; Etoposide

Cancer type

Small Cell Lung Cancer

Disease stage

Required: Stage IV

Histologically confirmed ES-SCLC, unsuitable for local radical therapy

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: hdac inhibitor

Cannot have received: immune checkpoint inhibitor

Lab requirements

Blood counts

adequate hematological function

Kidney function

adequate renal function

Liver function

adequate hepatic function

Cardiac function

adequate cardiac function; QTc ≤450 ms

Adequate organ function (hematological, hepatic, renal, cardiac). Uncontrolled cardiovascular disease or QTc >450 ms [excluded].

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT07373964 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

What disease stage is eligible?

Stage IV is required.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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