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Non-Small Cell Lung CancerPhase 2NSCLC， YAPNCT07412262

A Study of Chidamide Combined With Ivonescimab in the Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) With Acquired Resistance to Immunotherapy and High Yes-associated Protein (YAP) Expression

A Phase 2 study testing Chidamide in combination with Ivonescimab in people with Non-Small Cell Lung Cancer, run by Guangdong Association of Clinical Trials at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a prospective, single-arm, multi-center, phase II clinical trial to evaluate the efficacy and safety of Chidamide in combination with Ivonescimab in the treatment of advanced non-small cell lung cancer with secondary immune resistance and high YAP protein expression. 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?
Chidamide in combination with Ivonescimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
2 sitesChina
Study dates
28 Aug 2026to 31 Mar 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Written informed consent must be signed before implementing any trial-related procedures;
  • Age ≥18 years old;
  • Have histologically or cytologically confirmed locally advanced (IIIB/IIIC stage), metastatic or recurrent (IV stage) non-small cell lung cancer (NSCLC) that is not operable and not suitable for radical concurrent chemoradiotherapy, as classified by the 9th edition of the TNM staging system of the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer;
  • Previously received first-line PD-1/PD-L1 inhibitor monotherapy or combination therapy, with a progression-free survival (PFS) of ≥ 6 months under the initial PD-1/PD-L1-containing treatment regimen;
  • Previously received only first-line systemic treatment;
  • Able to provide 15 pieces of biopsied tumor tissue or tumor tissue sections after PD-1/PD-L1 treatment resistance, pathologically confirmed as non-small cell lung cancer, and centrally laboratory-confirmed high YAP protein expression. Eligible subjects voluntarily provide 5-15 sections of tumor tissue samples from initial diagnosis. (YAP immunohistochemical staining intensity is graded as 0 (negative), 1+ (weak), 2+ (moderate), and 3+ (strong); the proportion of positive tumor cells is graded as 0 (0-5%), 1+ (6-25%), 2+ (26-50%), 3+ (51-75%), and 4+ (>75%). The YAP IHC score is calculated by multiplying the staining intensity by the proportion of positive tumor cells: YAP IRS = Staining Intensity (A) × Proportion of Positive Tumor Cells (B). A YAP IHC score < 6 indicates low YAP expression, and ≥ 6 indicates high YAP expression);
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  • Asymptomatic brain metastasis patients are eligible for enrollment;
  • Palliative radiotherapy completed within 2 weeks before study enrollment is allowed, and radiotherapy-related toxicity has recovered to ≤ Grade 1 (CTCAE 5.0). Radiated lesions are not considered evaluable lesions unless there is evidence of progression after radiotherapy;
  • No prior use of any traditional Chinese medicine (TCM) with anti-tumor effects, or prior use of TCM with anti-tumor effects no more than 3 times (one dose counts as one time), and discontinuation of such TCM for ≥ 2 weeks before the start of study drug treatment.
  • Patients must meet the following laboratory test requirements at screening:
  • Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L without the use of growth factors in the past 14 days;
  • Platelet count ≥ 80 × 10⁹/L and hemoglobin ≥ 80 g/L without blood transfusion in the past 14 days;
  • Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × Upper Limit of Normal (ULN) (patients with liver metastasis are allowed to have ALT or AST ≤ 5 × ULN);
  • Total bilirubin ≤ 1.5 × ULN (patients with liver metastasis or biliary obstructive tumors are allowed to have ≤ 2.5 × ULN);
  • Serum creatinine ≤ 1.5 × ULN and creatinine clearance rate (calculated by the Cockcroft-Gault formula) ≥ 45 ml/min;
  • ECOG performance status score of 0-1;
  • Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN;
  • Expected survival time > 12 weeks;
  • Negative pregnancy test (applicable only to women of childbearing potential).

Who cannot join

  • Have a history of severe bleeding tendency or coagulation disorders; have significant clinical bleeding symptoms within 4 weeks before enrollment, including but not limited to gastrointestinal bleeding, hemoptysis (defined as coughing or expectorating ≥ 1 teaspoon of fresh blood or small blood clots or only coughing blood without sputum, subjects with blood in sputum are allowed to enroll), nasal bleeding (excluding epistaxis and retracted nasal blood); continuous antiplatelet or anticoagulant therapy within 14 days before the first dose;
  • History of gastrointestinal perforation and/or fistula, gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), esophagogastric varices, severe ulcers, unhealed wounds, abdominal fistulas, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months before the first dose; extensive intestinal resection (partial colectomy or extensive small bowel resection complicated by chronic diarrhea);
  • Hypersensitivity to any study drug or its components;
  • Exclusion of central squamous cell lung cancer invading large blood vessels;
  • Patients who experienced Grade 3 or above immune-related adverse reactions with prior immunotherapy drugs, and investigators assess that immunotherapy has safety concerns with risks outweighing benefits;
  • Any arterial thromboembolic event, Grade 3 or above venous thromboembolic event as specified by NCI CTCAE 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months before the first dose;
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  • Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before the first dose;
  • Complicated with severe uncontrolled concurrent infections or other severe uncontrolled comorbidities, moderate or severe renal impairment (e.g., progressive infection, uncontrolled hypertension, diabetes mellitus, etc.);
  • Active hepatitis B or C infection (hepatitis B surface antigen positive and hepatitis B virus DNA > 1 × 10³ copies/mL; hepatitis C virus RNA > 1 × 10³ copies/mL);
  • Human Immunodeficiency Virus (HIV) infection (HIV antibody positive);
  • Clinically significant active infection, active pulmonary tuberculosis;
  • Past or current clinically active interstitial lung disease; current active pneumonia; current radiation pneumonitis requiring hormone therapy;
  • Evidence of severe or uncontrolled systemic diseases (e.g., severe mental or neurological diseases, epilepsy, or dementia not stably controlled by drugs; unstable or decompensated respiratory, cardiovascular, hepatic, or renal diseases; uncontrolled hypertension [i.e., hypertension ≥ CTCAE Grade 3 despite drug treatment]; hyperglycemia [fasting blood glucose > 10 mmol/L]);
  • Clinically significant ventricular arrhythmia within 12 months before the first dose, atrial fibrillation not stably controlled by drugs, unstable angina pectoris, congestive heart failure, chronic heart failure with New York Heart Association (NYHA) classification ≥ Grade 2, or vascular diseases (e.g., aortic aneurysm at risk of rupture), or other cardiac impairments that may affect the safety evaluation of study drugs (e.g., uncontrolled arrhythmia, myocardial ischemia, etc.);
  • Past or current concurrent other malignant tumors (except for well-controlled non-melanoma cutaneous basal cell carcinoma, in situ breast/cervical cancer, and other malignant tumors that have been well-controlled without treatment for the past five years);
  • Tumor invasion of large vascular structures (e.g., pulmonary artery, superior vena cava, or inferior vena cava) detected at screening, or obvious necrosis/cavitation, which is judged by investigators to have a high risk of bleeding;
  • Active bleeding or taking therapeutic doses of anticoagulant drugs with a tendency to major bleeding;
  • Clinically uncontrolled pleural effusion/ascites/pericardial effusion;
  • Currently participating in interventional clinical study treatment, or receiving other study drugs or study devices within 2 weeks before the first dose;
  • Systemic treatment with Chinese patent medicines indicated for lung cancer or immunomodulatory drugs (including thymopeptides, interferons, interleukins, excluding local use for controlling pleural effusion) within 2 weeks before the first dose;
  • History of solid organ or hematopoietic stem cell transplantation;
  • Diagnosis of autoimmune disease and receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of the study. Note: Physiological doses of glucocorticoids (≤ 20 mg/day prednisone or equivalent) are allowed;
  • Failure to fully recover from toxicity and/or complications caused by any intervention before the start of treatment (i.e., ≤ Grade 1 or return to baseline, excluding fatigue or alopecia);
  • Vaccination with live vaccines within 30 days before the first dose (Cycle 1, Day 1). Note: Inactivated viral vaccines for seasonal influenza administered by injection are allowed within 30 days before the first dose; however, intranasal attenuated live influenza vaccines are not allowed;
  • Pregnant or lactating women, and fertile patients unwilling to use contraceptive measures;
  • Concurrent other malignant tumors requiring treatment;
  • Patients judged by investigators to be unsuitable for participating in the study.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Qing Zhou, MD contact

+86 02083827812

gzzhouqing@126.com

Yi-chen Zhang, MD contact

86 19128287863

China2 sites, 2 recruiting

  • Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China

    Guangzhou, Guangdong, 510080

    Qing Zhou, +86 02083827812, gzzhouqing@126.com

    Yi-Chen Zhang, +8619128287863

    Recruiting

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

    Wuhan, Hubei, 430030

    Liu Huang, +86 1520710850, huangliu017@163.com

    Not yet recruiting

Other trials in China

About this study

Official title: A Prospective, Single-Arm, Multicenter, Phase II Clinical Study of Chidamide Combined With Ivonescimab in the Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) With Acquired Resistance to Immunotherapy and High Yes-associated Protein (YAP) Expression

This is a prospective, single-arm, multi-center, phase II clinical trial to evaluate the efficacy and safety of Chidamide in combination with Ivonescimab in the treatment of advanced non-small cell lung cancer with secondary immune resistance and high YAP protein expression.

Read the detailed description

Not provided

Being tested
Chidamide in combination with Ivonescimab
Keywords
YAP protein, Acquired immune resistance
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.

  • Chidamide in combination with IvonescimabDrug

    Also called Tucidinostat, CS055, AK112

    Chidamide 20mg/dose orally BIW; Ivonescimab 20mg/kg intravenously (IV) Q3W

Study groups in NCT07412262
Study groupRoleWhat they receive
The combination of Chidamide plus Ivonescimab(AK112)ExperimentalParticipants will take 20 mg of Chidamide by month every 3-4 days on a twice weekly (BIW) schedule and Ivonescimab (AK112) 20 mg/kg intravenously (IV) Q3W.
Receives: Drug: Chidamide in combination with Ivonescimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival(PFS) per Response Evaluation Criteria in Solid tumors (RECIST) v1.1

    PFS is measured from the start of treatment until progression or death, whichever is first met

    Measured: From the start of treatment until disease progression or death (assessed up to 24 months)

Secondary outcomes (5)

  1. Object Response Rate (ORR)

    ORR is defined as percentage of participants with Complete Response(CR) and Partial Response(PR), assessed by the investigators according to the RECIST 1.1.

    Measured: Every 6 weeks (RECIST 1.1) until progression(up to 24 months)

  2. Disease Control Rate(DCR)

    DCR based on RECIST 1.1 assessed by the investigators, the proportion(%) of patients with at least one visit response of CR or PR, or SD.

    Measured: From the first dose of study drug to the first date of documentation of disease progression or death whichever occurred first, up to approximately 2 years

  3. Duration of Response(DOR)

    DOR is defined as the time from the first documentation of CR or PR to the date of first documentation of PD or death (whichever occurred first) in participants with confirmed CR or PR based on RECIST 1.1 assessed by investigators.

    Measured: From date of first documented confirmed CR or PR until date of first documentation of PD or death whichever occurred first, up to approximately 2 years

  4. Overall Survival

    Overall Survival(OS) was measured from the date of first dose of study drug until date of death from any cause. Participants who were lost to follow-up and the participants who alive at the date of data cutoff was censored at the date the participant was last known alive, whichever came earlier.

    Measured: From the date of first dose of study drug until date of death from any cause (up to approximately 5 years).

  5. Adverse Events

    The incidence of hematological and non-hematological adverse events, events will be classified according to CTCAE v5.0

    Measured: From first dose until 30 days after the last dose, up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2026
  2. Study start28 Aug 2026 (estimated)
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Mar 2029 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07412262
Sponsor's protocol ID
CTONG 2505
Acronym
NSCLC， YAP
Status last verified
Jan 2026
First submitted
9 Feb 2026
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chidamide in combination with Ivonescimab in people with Non-Small Cell Lung Cancer, run by Guangdong Association of Clinical Trials at 2 sites 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 19 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Qing Zhou, MD (+86 02083827812, gzzhouqing@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival(PFS) per Response Evaluation Criteria in Solid tumors (RECIST) v1.1 (time frame: From the start of treatment until disease progression or death (assessed up to 24 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07412262.

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 25 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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