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Non Small Cell Lung CancerPhase 2NCT05068427

Trial of Chidamide in Combination With Envafolimab in Patients With PD-1 Inhibitor Resistant Advanced NSCLC.

A Phase 2 study testing Chidamide and Envafolimab in people with Non Small Cell Lung Cancer, run by Chipscreen Biosciences, Ltd. at 12 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is to evaluate the preliminary efficacy and safety of Chidamide combined with Envafolimab in patients with PD-1 inhibitor resistant advanced NSCLC. 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 and Envafolimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
12 sitesChina
Study dates
23 Nov 2021to 16 May 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

  • Male or female, age ≥ 18 years.
  • Histologically or cytologically confirmed diagnosis of unresectable locally advanced or metastatic (stage IIIB-IV) NSCLC.
  • Previously treated with a PD-1 inhibitor, alone or in combination with another systemic therapy, and have unequivocal progressive disease confirmed by imaging or pathology. The PD-1 inhibitor must be the products already in the market.
  • Previously received at least 2 systemic chemotherapy regimens (containing platinum is required).
  • Tumor tissue can be provided for research.
  • ECOG performance status of 0 or 1.
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  • Have at least one measurable target lesion as defined by RECIST v.1.1.
  • The following laboratory results within 7 days prior to study drug administration: Hemoglobin ≥90g/L independent of transfusion, Neutrophils ≥1.5×109/L, Platelets ≥90×109/L, Creatinine ≤1.5×ULN, Bilirubin ≤1.5×ULN (unless known Gilbert's disease where it must be ≤3×ULN), AST and ALT ≤2.5×ULN (unless known hepatic metastasis where it must be ≤5×ULN); INR≤1.5×ULN, PT and aPTT ≤1.5×ULN.
  • Life expectancy ≥12 weeks.
  • Have the ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Prior use of a PDL1 or PDL2, anti-CTLA4 antibody or any other antibody or drug that specifically targets immune checkpoint pathway.
  • Prior use of HDAC inhibitor.
  • Known history of intolerance to PD-1 inhibitor treatment.
  • Known driver genes mutation (EGFR, ALK, ROS1 or RET).
  • Use of any anti-tumor therapy or investigational agent and device within 28 days before the first dose of study drug; or received thoracic radiation >30Gy within 6 months before the first dose.
  • Use of systemic immunosuppressive therapy within 28 days before the first dose of study drug. Inhaled or topical steroids and physiological dose of systemic glucocorticoid (≤10 mg daily prednisone equivalents) are permitted.
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  • Received a live vaccine within 28 days before the first dose of study drug 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 (craniotomy, thoracotomy or laparotomy) within 28 days before the first dose of study drug, or there are still serious and unhealed wounds, ulcers or fractures judged by the investigator during the screening period.
  • Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
  • Before the first dose of study drug, subjects who has not recovered ( ≤ Grade 1 defined by CTCAE V5.0) from AEs due to prior anti-cancer therapy. Except for hair loss, or laboratory test abnormalities assessed by the investigator as clinically insignificant.
  • Subjects with obvious clinical symptoms or need drainage of pleural effusion, ascites and pericardial effusion, or who received drainage for the purpose of treatment within 1 month before the first dose of study drug.
  • Active autoimmune disease that has required systemic treatment in past 2 years (i.e., corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and are allowed.
  • Known central nervous system (CNS) metastases and/or carcinomatous meningitis. Previously treated brain metastases may be an exception if stable and specific other criteria are met.
  • Uncontrollable or major cardiovascular and cerebrovascular diseases, including, but not limited to:
  • 1)Congestive heart failure (New York Heart Association Grade II or above); unstable angina or myocardial infarction within the previous 6 months; or cardiac arrhythmia requiring treatment; or left ventricular ejection fraction (LVEF)<50%; 2)Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, amorphous cardiomyopathy); 3)History of clinically significant QTcF interval prolongation, or a QTcF interval > 470 msec(female) or > 470 msec(male) during the screening period.
  • 4)Symptomatic coronary heart disease requiring medical management during the screening period.
  • 5)Cerebrovascular accidents (i.e., cerebral hemorrhage, cerebral infarction, transient ischemic attack) within the previous 6 months; 15.Active bleeding with significant clinical significance within the previous 2 months; or subject who is taking anticoagulants, or subject with clear high-risk bleeding tendency during the screening period.
  • 16.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 the previous 6 months; or immune-related pneumonia after previous treatment with PD-1 inhibitors.
  • 17.Obvious gastrointestinal abnormalities during the screening period, which may affect the intake, transport or absorption of drugs; or history of gastrointestinal perforation and / or fistula; or history of peptic ulcer within the previous 6 months or intestinal obstruction within the previous 3 months.
  • 18.Urinary protein ≥ 2+ and quantitative urinary protein ≥ 1g/24 h during the screening period; 19.Known active pulmonary tuberculosis, or subject who is receiving antituberculous treatment or having received antituberculous treatment within the previous 1 years.
  • 20.Active infection requiring intravenous therapy; or severe infection within 28 days before the first dose of study drug.
  • 21.Active hepatitis B (HBsAg and HBV DNA positive), or hepatitis C (HCV antibody test and HCV RNA positive); known HIV positive or history of AIDS or other serious infectious diseases.
  • 22.History of pulmonary embolism within the previous 6 months or deep venous thrombosis or any other serious venous thromboembolic event within the previous 3 months.
  • 23.History of second malignancy, except for carcinoma in situ with adequate treatment and no evidence of disease recurrence, non-melanomatous skin cancer or lentiginous melanoma, completely relieved for at least 2 years before the first dose of study drug and estimated that no other treatment is required during the study period.
  • 24.Contraindications to any of the study drug ingredients. 25.History of hypersensitivity to monoclonal antibody, Chidamide, study drug, or any of its excipients.
  • 26.History of alcohol or drug abuse. 27.Unwilling or unable to comply with procedures required in this protocol. 28.Pregnant or breast-feeding women. 29.Women of childbearing age or spouses of male patients who are unwilling or unable to use effective methods for contraception during the whole treatment period of this trial and within 12 weeks after the last use of Chidamide or within 150 days after the last use of Envafolimab (whichever is the latest).

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

China12 sites

  • Baoding No.2 Central Hospital

    Baoding, Hebei, 072750

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Southern Medical University Affiliated Nanfang Hospital

    Guangzhou, Guangdong, 510515

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310014

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, 230601

  • Linyi Cancer Hospital

    Linyi, Shandong, 276002

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning, Guangxi, 530021

  • Nantong Tumor Hospital

    Nantong, Jiangsu, 226361

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200030

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200120

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221009

  • Henan Cancer Center

    Zhengzhou, Henan, 450008

Other trials in China

About this study

Official title: A Phase II Trial of Chidamide in Combination With Envafolimab in Patients With PD-1 Inhibitor Resistant Advanced Non-Small Cell Lung Cancer(NSCLC).

This study is to evaluate the preliminary efficacy and safety of Chidamide combined with Envafolimab in patients with PD-1 inhibitor resistant advanced NSCLC.

Read the detailed description

This study including two phases: (1) Pre-test Phase, 3~6 patients will be enrolled and receive 20 mg Chidamide BIW and 400 mg Envafolimab Q4W. The main object of pre-test phase is to evaluate the preliminary safety and tolerability of Chidamide when in combination with Envafolimab. (2) Formal experiment Phase, 63 patients will be enrolled and receive 30 mg Chidamide BIW and 400 mg Envafolimab Q4W, to evaluate the efficacy and safety of Chidamide when in combination with Envafolimab in patients with PD-1 inhibitor resistant advanced NSCLC.

This study is also to explore the gene expression and variation, PD-L1 and HDAC2 proteins expression levels in tumor tissue samples, the circulating tumor DNA (ctDNA) in plasma, and the potential correlation between peripheral blood cytokines and clinical preliminary efficacy and safety.

Being tested
Chidamide, Envafolimab
Keywords
Chidamide, Envafolimab, Non Small Cell Lung Cancer, Immunotherapy 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.

  • ChidamideDrug

    Also called CS055

    20mg or 30mg orally twice per week(BIW)

  • EnvafolimabDrug

    Also called KN035

    400mg subcutaneous infusions every 4 weeks

Study groups in NCT05068427
Study groupRoleWhat they receive
Chidamide + EnvafolimabExperimentalPatients receive Chidamide 20mg or 30mg orally twice per week and Envafolimab 400mg subcutaneous infusions every 4 weeks untile disease progression or unacceptable toxicity.
Receives: Drug: Chidamide; Drug: Envafolimab

What is being measured

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

  1. objective response rate (ORR)

    ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.

    Measured: Response is assessed once every 8 weeks, assessed up to 24 weeks.

Secondary outcomes (7)

  1. disease control rate (DCR)

    Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.

    Measured: From the first date of response until the date of first documented progression, assessed up to 24 weeks

  2. duration of response (DOR)

    DOR is measured from the first date when criteria for response is met until the first date when the criteria for progression is met

    Measured: From the first date of response until the date of first documented progression, assessed up to 24 months

  3. time to progression (TTP)

    TTP is measured from date of randomization until progression not including death

    Measured: From date of randomization until the date of first documented progression, assessed up to 24 months

  4. time to response (TTR)

    TTR is measured from date of randomization until response

    Measured: From date of randomization until the date of first documented response, assessed up to 24 months

  5. progression-free survival (PFS)

    PFS is measured from the date of randomization until progression or death, whichever is first met

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

  6. overall survival (OS)

    OS is measured from the date of randomization until death

    Measured: From date of randomization until the date of death from any cause, assessed up to 24 months

  7. Toxicity according to NCI CTCAE v5.0 criteria

    Safety evaluation as measured by adverse events (AE), vital signs and abnormal laboratory results according to CTCAE V5.0.

    Measured: From date of randomization until the end of study, assessed up to 24 months

Timeline

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

  1. First posted5 Oct 2021
  2. Study start23 Nov 2021
  3. Primary completion23 Feb 2023
  4. Study completion16 May 2024

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
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05068427
Sponsor's protocol ID
CDM205
Status last verified
Aug 2024
First submitted
27 Sep 2021
Last updated
7 Aug 2024
Results posted
No
Data monitoring committee
Yes
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 and Envafolimab in people with Non Small Cell Lung Cancer, run by Chipscreen Biosciences, Ltd. at 12 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 10 inclusion and 26 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 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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?

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?

objective response rate (ORR) (time frame: Response is assessed once every 8 weeks, assessed up to 24 weeks.). 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 NCT05068427.

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 7 Aug 2024.

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