A Study of Tucidinostat Combined With Tislelizumab as First-line Treatment in Advanced NSCLC (NCT05519865) | Clinical Trial Compass
CompletedPhase 2
A Study of Tucidinostat Combined With Tislelizumab as First-line Treatment in Advanced NSCLC
China118 participantsStarted 2022-10-26
Plain-language summary
A Randomized, Double-blind, Controlled, Multi-center Phase 2 Clinical study to Investigate the Efficacy and Safety of Tucidinostat (Chidamide) Combined with Tislelizumab as First-line Treatment for PD-L1 Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years, Male or female.
✓. Histologically or cytologically confirmed diagnosis of unresectable locally advanced or metastatic (stage IIIB-IV) NSCLC.
✓. Must have no prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC.
✓. Must have positive PD-L1 expression in tumor tissue.
✓. ECOG performance status of 0 or 1.
✓. Must Have ≥1 measurable target lesion as defined by RECIST v.1.1.
✓. Must have adequate organ function.
✓. Life expectancy ≥ 12 weeks.
Exclusion criteria
✕. With EGFR or ALK gene mutation.
✕. Received prior targeted therapy.
✕. Prior use of HDAC inhibitor.
✕. Received prior therapies targeting PD-1, PD-L1, CTLA4, or any other immune checkpoint pathway.
✕. Received any anti-tumor therapy or investigational agent and device within 28 days before the first dose of study treatment.
✕. Received radiotherapy within 2 weeks or thoracic radiation \>30Gy within 6 months before the first dose of study treatment.
✕. Received systemic immunosuppressive drugs within 28 days before the first dose of study treatment. Inhaled or topical steroids and physiological dose of systemic glucocorticoid (≤10 mg daily prednisone equivalents) are permitted.
✕. Received systemic immunostimulatory drugs within 28 days before the first dose of study treatment.