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A Study of Tucidinostat Combined With Tislelizumab as First-line Treatment in Advanced NSCLC | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

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

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

NCT05519865•Chipscreen Biosciences, Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+22 more criteria

Locations (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

October 26, 2022

Primary Completion Date

October 1, 2024

Completion Date

October 1, 2024

Last Updated

August 7, 2024

Enrollment

118

ACTUAL participants

Conditions

Non Small Cell Lung Cancer

Interventions

Tucidinostat

DRUG

Tislelizumab

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 7, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers

A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer.

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)

A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study)