A Study of Tucidinostat Combined With Tislelizumab as First-line Treatment in Advanced NSCLC

Prior treatment

• 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.
• Received a live vaccine within 28 days before the first dose of study treatment or planned to receive during the study period. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; and COVID-19 vaccine also are allowed.
• Received major surgery within 28 days before the first dose of study treatment.
• Has not recovered ( ≤ Grade 1 defined by CTCAE V5.0) from AEs due to prior anti-cancer therapy.
• Has hydrothorax and ascites with obvious symptoms or requiring repeated drainage within 1 month before the first dose of study treatment.
• History of hemoptysis within 2 weeks or active bleeding within 2 months before the first dose of study treatment; or subject who is taking anticoagulants, or subject with clear high-risk bleeding tendency during the screening period.
• History of serious thromboembolism within 6 months before the first dose of study treatment.
• Suspected interstitial lung disease (ILD) or pulmonary fibrosis or pulmonary inflammation requiring treatment; or history of lung disease treated with oral or intravenous steroids within 6 months before the first dose of study treatment.
• Obvious gastrointestinal abnormalities during the screening period, which may affect the intake, transport or absorption of drugs.
• Active infection requiring intravenous therapy; or severe infection within 28 days before the first dose of study treatment.
• Known active pulmonary tuberculosis, or subject who is receiving antituberculous treatment or having received antituberculous treatment within 1 year before the first dose of study treatment.
• Active autoimmune diseases during the screening period, and have received systemic treatment within 2 years before the first dose of study treatment.
• Contraindications to any of the study drug ingredients.

Other illness

• Uncontrollable or major cardiovascular and cerebrovascular disease.
• Active hepatitis B or hepatitis C.
• HIV positive or history of AIDS or other serious infectious diseases.
• History of malignant tumor.
• History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
• History of hypersensitivity to monoclonal antibody, Chidamide, study drugs, or any of its excipients.
• History of alcohol or drug abuse.
• Pregnant or breast-feeding women. Male/Female is unwilling or unable to use a highly effective method of birth control.
  • 33\. Any condition not suitable for participating in the trial in the opinion of the Investigator.

Lab values

• With EGFR or ALK gene mutation.

Other

• Has symptomatic and untreated central nervous system (CNS) metastases.
• Urinary protein ≥ 2+ and quantitative urinary protein ≥ 1g/24 h during the screening period.
• Unwilling or unable to comply with procedures required in this protocol.

• 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.
• Signed informed consent form (ICF).