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Trial Title:
A Study of Tucidinostat Combined With Tislelizumab as First-line Treatment in Advanced NSCLC
NCT ID:
NCT05519865
Condition:
Non Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Tislelizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Tucidinostat
Description:
30mg orally BIW
Arm group label:
Tucidinostat Combined with Tislelizumab
Other name:
Chidamide
Other name:
CS055
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
200 mg intravenously (IV) Q3W
Arm group label:
Tislelizumab
Arm group label:
Tucidinostat Combined with Tislelizumab
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥ 18 years, Male or female.
2. Histologically or cytologically confirmed diagnosis of unresectable locally advanced
or metastatic (stage IIIB-IV) NSCLC.
3. Must have no prior systemic anti-tumor therapy for locally advanced or metastatic
NSCLC.
4. Must have positive PD-L1 expression in tumor tissue.
5. ECOG performance status of 0 or 1.
6. Must Have ≥1 measurable target lesion as defined by RECIST v.1.1.
7. Must have adequate organ function.
8. Life expectancy ≥ 12 weeks.
9. Signed informed consent form (ICF).
Exclusion Criteria:
1. With EGFR or ALK gene mutation.
2. Received prior targeted therapy.
3. Prior use of HDAC inhibitor.
4. Received prior therapies targeting PD-1, PD-L1, CTLA4, or any other immune
checkpoint pathway.
5. Received any anti-tumor therapy or investigational agent and device within 28 days
before the first dose of study treatment.
6. Received radiotherapy within 2 weeks or thoracic radiation >30Gy within 6 months
before the first dose of study treatment.
7. 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.
8. Received systemic immunostimulatory drugs within 28 days before the first dose of
study treatment.
9. 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.
10. Received major surgery within 28 days before the first dose of study treatment.
11. Has not recovered ( ≤ Grade 1 defined by CTCAE V5.0) from AEs due to prior
anti-cancer therapy.
12. Has symptomatic and untreated central nervous system (CNS) metastases.
13. Has hydrothorax and ascites with obvious symptoms or requiring repeated drainage
within 1 month before the first dose of study treatment.
14. Uncontrollable or major cardiovascular and cerebrovascular disease.
15. 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.
16. History of serious thromboembolism within 6 months before the first dose of study
treatment.
17. 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.
18. Obvious gastrointestinal abnormalities during the screening period, which may affect
the intake, transport or absorption of drugs.
19. Urinary protein ≥ 2+ and quantitative urinary protein ≥ 1g/24 h during the screening
period.
20. Active infection requiring intravenous therapy; or severe infection within 28 days
before the first dose of study treatment.
21. 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.
22. Active hepatitis B or hepatitis C.
23. HIV positive or history of AIDS or other serious infectious diseases.
24. History of malignant tumor.
25. Active autoimmune diseases during the screening period, and have received systemic
treatment within 2 years before the first dose of study treatment.
26. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell
transplantation.
27. Contraindications to any of the study drug ingredients.
28. History of hypersensitivity to monoclonal antibody, Chidamide, study drugs, or any
of its excipients.
29. History of alcohol or drug abuse.
30. Unwilling or unable to comply with procedures required in this protocol.
31. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Pulmonary Hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Start date:
October 26, 2022
Completion date:
October 2024
Lead sponsor:
Agency:
Chipscreen Biosciences, Ltd.
Agency class:
Industry
Source:
Chipscreen Biosciences, Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05519865