A Randomized, Double-blind, Controlled, Multi-center Phase II Clinical Trial of Tucidinostat Combined With Tislelizumab as First-line Treatment for PD-L1 Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Chipscreen Biosciences, Ltd.1 site in 1 country118 target enrollmentOctober 26, 2022

ConditionsNon Small Cell Lung Cancer

InterventionsTucidinostat Tislelizumab

DrugsTucidinostat Tislelizumab

Overview

Phase: Phase 2
Intervention: Tucidinostat
Conditions: Non Small Cell Lung Cancer
Sponsor: Chipscreen Biosciences, Ltd.
Enrollment: 118
Locations: 1
Primary Endpoint: Progression Free Survival (PFS) per RECIST v1.1
Status: Completed
Last Updated: 12 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 26, 2022

End Date

November 18, 2024

Last Updated

12 days ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chipscreen Biosciences, Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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
•Must Have ≥1 measurable target lesion as defined by RECIST v.1.
•Must have adequate organ function.
•Life expectancy ≥ 12 weeks.
•Signed informed consent form (ICF).

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.
•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.