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)
Recruiting
Phase 2
Interventional Study
Small Cell Lung Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 36 (estimated)
- Sponsor
- China Medical University, China · Other
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About This Trial
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…
Trial Locations
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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 (…
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