Non Small Cell Lung CancerPhase 2NCT05519865
A Study of Tucidinostat Combined With Tislelizumab as First-line Treatment in Advanced NSCLC
A Phase 2 study testing Tucidinostat and Tislelizumab in people with Non Small Cell Lung Cancer, run by Chipscreen Biosciences, Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Tucidinostat and Tislelizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteChina
- Study dates
- 26 Oct 2022to 18 Nov 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Must have adequate organ function.
- Life expectancy ≥ 12 weeks.
- Signed informed consent form (ICF).
Who cannot join
- 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.
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- 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.
- History of serious thromboembolism within 6 months before the first dose of study treatment.
- 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.
- Obvious gastrointestinal abnormalities during the screening period, which may affect the intake, transport or absorption of drugs.
- Urinary protein ≥ 2+ and quantitative urinary protein ≥ 1g/24 h during the screening period.
- Active infection requiring intravenous therapy; or severe infection within 28 days before the first dose of study treatment.
- 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.
- Active hepatitis B or hepatitis C.
- HIV positive or history of AIDS or other serious infectious diseases.
- History of malignant tumor.
- Active autoimmune diseases during the screening period, and have received systemic treatment within 2 years before the first dose of study treatment.
- History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- Contraindications to any of the study drug ingredients.
- History of hypersensitivity to monoclonal antibody, Chidamide, study drugs, or any of its excipients.
- History of alcohol or drug abuse.
- Unwilling or unable to comply with procedures required in this protocol.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Being tested
- Tucidinostat, Tislelizumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TucidinostatDrug
Also called Chidamide, CS055
30mg orally BIW
TislelizumabDrug
200 mg intravenously (IV) Q3W
| Study group | Role | What they receive |
|---|---|---|
| Tucidinostat Combined with Tislelizumab | Experimental | Subjects receive Tucidinostat 30mg orally biw and Tislelizumab 200 mg intravenously (IV) Q3W. Receives: Drug: Tucidinostat; Drug: Tislelizumab |
| Tislelizumab | Active comparator | Subjects receive Tislelizumab 200 mg intravenously (IV) Q3W. Receives: Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years
Secondary outcomes (9)
Overall response rate (ORR)
Proportion of participants who have a partial response (PR) or complete response (CR) to therapy according to RECIST 1.1 or iRECIST.
Measured: Up to 2 years
Progression Free Survival (PFS) per iRECIST
PFS assessed by investigator per iRECIST, measured from the date of randomization until progression or death, whichever is first met.
Measured: Up to 2 years
Overall Survival (OS)
From the first dose of treatment until the date of death from any cause.
Measured: Up to 2 years
Disease control rate (DCR)
Proportion of participants in partial, complete or stable disease according to RECIST 1.1 or iRECIST.
Measured: Up to 2 years
Duration of response (DOR)
From the first date of response until the date of first documented progression according to RECIST 1.1 or iRECIST.
Measured: Up to 2 years
Progression-free survival of 6 months
Proportion of subjects who did not have disease progression(according to RECIST1.1 or iRECIST) or death at 6 months after randomization.
Measured: 6 months after randomization
time to progression (TTP)
TTP is measured from date of randomization until progression(according to RECIST1.1 or iRECIST) not including death.
Measured: Up to 2 years
time to response (TTR)
TTR is measured from date of randomization until response
Measured: Up to 2 years
Safety and Tolerability
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start26 Oct 2022
- Primary completion18 Nov 2024
- Study completion18 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Chipscreen Biosciences, Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chipscreen Biosciences, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Caicun Zhou, Principal investigator, caicunzhoudr@163.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519865
- Sponsor's protocol ID
- CDM206
- Status last verified
- Apr 2026
- First submitted
- 23 Aug 2022
- Last updated
- 20 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05519865
- Acronym / sponsor ID
- CDM206
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Chipscreen Biosciences, Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 18 Nov 2024 (actual)
- Study completion
- 18 Nov 2024 (actual)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tucidinostat Combined with Tislelizumab | Experimental | Drug: Tucidinostat, Drug: TislelizumabSubjects receive Tucidinostat 30mg orally biw and Tislelizumab 200 mg intravenously (IV) Q3W. |
| Tislelizumab | Active comparator | Drug: TislelizumabSubjects receive Tislelizumab 200 mg intravenously (IV) Q3W. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (32 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TucidinostatAlso: Chidamide, CS05530mg orally BIW | Drug | Tucidinostat Combined with Tislelizumab |
| Tislelizumab200 mg intravenously (IV) Q3W | Drug | Tislelizumab, Tucidinostat Combined with Tislelizumab |
Primary outcome
Progression Free Survival (PFS) per RECIST v1.1
Time frame: Up to 2 years
PFS assessed by investigator per RECIST v1.1, measured from the date of randomization until progression or death, whichever is first met.
9 secondary outcomes
Overall response rate (ORR)
Time frame: Up to 2 years
Progression Free Survival (PFS) per iRECIST
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 2 years
Disease control rate (DCR)
Time frame: Up to 2 years
Duration of response (DOR)
Time frame: Up to 2 years
Progression-free survival of 6 months
Time frame: 6 months after randomization
time to progression (TTP)
Time frame: Up to 2 years
time to response (TTR)
Time frame: Up to 2 years
Safety and Tolerability
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caicun Zhou principal investigator
caicunzhoudr@163.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tucidinostat and Tislelizumab in people with Non Small Cell Lung Cancer, run by Chipscreen Biosciences, Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) per RECIST v1.1 (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.