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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.