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

NCT05519865 | Completed Phase 2

• 1 other identifier: CDM206
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) per RECIST v1.1

  PFS assessed by investigator per RECIST v1.1, measured from the date of randomization until progression or death, whichever is first met.

  Up to 2 years

Secondary Outcomes (9)

• Overall response rate (ORR)

  Up to 2 years

• Progression Free Survival (PFS) per iRECIST

  Up to 2 years

• Overall Survival (OS)

  Up to 2 years

• Disease control rate (DCR)

  Up to 2 years

• Duration of response (DOR)

  Up to 2 years

Study Arms (2)

Tucidinostat Combined with Tislelizumab

EXPERIMENTAL

Subjects receive Tucidinostat 30mg orally biw and Tislelizumab 200 mg intravenously (IV) Q3W.

Drug: Tucidinostat; Drug: Tislelizumab

Tislelizumab

ACTIVE COMPARATOR

Subjects receive Tislelizumab 200 mg intravenously (IV) Q3W.

Drug: Tislelizumab

Interventions

Tucidinostat DRUG

30mg orally BIW

Also known as: Chidamide, CS055

Tucidinostat Combined with Tislelizumab

Tislelizumab DRUG

200 mg intravenously (IV) Q3W

Tislelizumab; Tucidinostat Combined with Tislelizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• Has not recovered ( ≤ Grade 1 defined by CTCAE V5.0) from AEs due to prior anti-cancer therapy.
• Has symptomatic and untreated central nervous system (CNS) metastases.
• Has hydrothorax and ascites with obvious symptoms or requiring repeated drainage within 1 month before the first dose of study treatment.
• Uncontrollable or major cardiovascular and cerebrovascular disease.
• 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.

Sponsors & Collaborators

• Chipscreen Biosciences, Ltd.: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; tislelizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Caicun Zhou

  caicunzhoudr@163.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 29, 2022
• Study Start: October 26, 2022
• Primary Completion: November 18, 2024
• Study Completion: November 18, 2024
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)