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ImmunotherapyPhase 2NCT05901584

Cadonilimab (AK104) With or Without CT as 2rd Line Treatment for ES-SCLC

A Phase 2 study testing Cadonilimab in people with Immunotherapy and Second-line Treatment, run by Second Affiliated Hospital of Zunyi Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is a phase II clinical study of Cadonilimab (AK104) combined with or without chemotherapy in the treatment of PD-1 inhibitor-resistant extensive stage small cell lung cancer Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Immunotherapy, Second-line Treatment
What is being tested?
Cadonilimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 Jan 2023to Dec 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients voluntarily participate in this study by signing an informed consent form.
  • Pathologically confirmed diagnosis of small cell lung cancer, with imaging confirmation of extensive stage with measurable lesions.
  • Patients who have been treated with at least one line of systemic platinum-containing chemotherapy regimen (with or without immunotherapy).
  • 4.18 - 75 years of age; ECOG PS score: 0 to 1; expected survival greater than 3 months.
  • 5.Major organ function within 7 days prior to treatment, meeting the following criteria:
  • Blood test criteria (in 14-day untransfused state):
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  • Hemoglobin (HB) ≥ 90g/L.
  • Absolute central granulocyte value (ANC) ≥ 1.5×109/L.
  • Platelets (PLT) ≥75×109/L.
  • ②Biochemistry needs to meet the following criteria:
  • <!-- -->
  • total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN).
  • alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5 × ULN, if accompanied by liver metastases, then ALT and AST ≤ 5 × ULN
  • serum creatinine (Cr) ≤ 1.5×ULN or creatinine clearance ≥ (CCr) 60 ml/min. ③Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ low limit of normal (50%).
  • 6.Female participants of reproductive age must use contraception methods such as IUD, pill, or condom during the study period and for 6 months after. Male participants must also agree to use contraception during the study period and for 6 months after. Additionally, female participants must have a negative serum or urine pregnancy test within 7 days prior to study entry and should not be breastfeeding.

Who cannot join

  • Patients with previous use of cardunilizumab.
  • non-small cell lung cancer (including lung cancer with a mixture of small cell and non-small cell carcinoma).
  • Patients with other types of cancer that occurred within the past 5 years or are currently present, with the exception of treated cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors that have not invaded the basement membrane (Ta, Tis, and T1).
  • Systemic antitumor therapy, including cytotoxic therapy, signal transduction inhibitors, immunotherapy, within 4 weeks prior to enrollment or planned during the current study dosing period (or have used mitomycin C within 6 weeks prior to treatment with the trial drug). Have had extended field radiotherapy (EF-RT) within 4 weeks prior to subgroup or have had field-limited radiotherapy to the tumor lesion to be evaluated within 2 weeks prior to subgroup.
  • Unremitted toxic reactions due to any prior treatment above CTCAE grade 1, excluding alopecia and neurotoxicity ≤ grade 2 due to oxaliplatin.
  • Individuals with various factors such as difficulty swallowing, chronic diarrhea, and intestinal obstruction may experience challenges with oral drug administration.
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  • with pleural effusion or ascites causing respiratory syndrome (≥ CTCAE grade 2 dyspnea).
  • Patients with brain metastases with symptoms or symptoms controlled for less than 2 months.
  • Patients with any severe and/or uncontrolled disease, including:
  • <!-- -->
  • Patients with poorly controlled blood pressure (systolic blood pressure ≥ 150 mmHg and diastolic blood pressure ≥ 100 mmHg).
  • Patients with myocardial ischemia of grade I or higher, myocardial infarction, arrhythmias (including QTc ≥ 480 ms), and congestive heart failure of grade 2 or higher (categorized according to the New York Heart Association (NYHA) classification) are included.
  • Active or uncontrolled serious infection (≥ CTC AE grade 2 infection).
  • Cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis requiring antiviral therapy.
  • Renal failure requiring hemodialysis or peritoneal dialysis.
  • This refers to a medical history of immunodeficiency, which can be acquired through HIV or other diseases, or congenital in nature. It also includes a history of organ transplantation.
  • poorly controlled diabetes (fasting blood glucose (FBG) >10 mmol/L).
  • urine routine suggesting urine protein ≥++ and confirmed 24-hour urine protein quantification >1.0 g.
  • Patients with seizures and requiring treatment. 10. Participants who have undergone major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to the start of the study will be excluded.
  • 11.Patients whose imaging shows that the tumor has invaded the critical vascular perimeter or who, in the judgment of the investigator, are at high risk of fatal hemorrhage due to tumor invasion of a critical vessel during the follow-up study.
  • 12.Patients with any physical signs or history of bleeding, regardless of severity; patients with any bleeding or hemorrhagic event ≥ CTCAE grade 3, unhealed wounds, ulcers or fractures within 4 weeks prior to subgroup.
  • 13.Individuals who have experienced an arterial or venous thrombotic event within the past 6 months, including cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis, and pulmonary embolisms, should take caution.
  • 14.Individuals with a history of psychotropic substance abuse or psychiatric disorders who are unable to abstain.
  • 15.having participated in clinical trials of other antineoplastic drugs within four weeks.
  • 16.Patients with concomitant diseases that are deemed to pose a significant risk to their safety or may hinder their ability to complete the study, as determined by the investigator, will be excluded.

Trial locations and contacts

1 site in 1 country.

Hu Ma, Ph.D contact

18115068816 ext. 085127596113

mahuab@163.com

Jianguo Zhou, Ph.D contact

18311543939 ext. 085127596113

jianguo.zhou@zmu.edu.cn

China1 site, 1 recruiting

  • The Second Affiliated Hospital of Zunyi Medical University

    Guizhou, ZunYi, 563000

    Jianguo Zhou, doctor, 18311543939 ext. 18311543939, jianguo.zhou@zmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: A Single-arm Multicenter Phase II Clinical Trial of Cadunilumab (Anti-PD-1/CTLA-4) in Combination With or Without Chemotherapy in Second-line Treatment for Patients With Extensive Stage Small Cell Lung Cancer

This study is a phase II clinical study of Cadonilimab (AK104) combined with or without chemotherapy in the treatment of PD-1 inhibitor-resistant extensive stage small cell lung cancer

Read the detailed description

This study is conducted by enrolling subjects with ES-SCLC who have previously failed first-line systemic therapy (platinum-containing chemotherapy in combination with or without atezolizumab and dulvalizumab), and all enrolled subjects will receive cadunilumab alone or in combination with chemotherapy and continue treatment in 3-week dosing cycles until toxicity is intolerable, there is no longer clinical benefit in the judgment of the investigator (in the investigator's judgment based on RECISTv1.1 imaging assessment and clinical status, etc.), completion of 24 months of treatment, or other criteria for termination of treatment in the protocol are met, whichever occurs first. Patients were observed for efficacy and side effects. Primary outcome: progression-free survival (PFS) based on RECIST v1.1 assessment. Secondary outcomes included: incidence and severity of adverse events; objective remission rate (ORR), disease control rate (DCR), duration of remission (DoR), time to remission (TTR), and overall survival (OS). Finally, mRNA expression profiles in tumor tissue samples were determined by gene sequencing to analyze the correlation between molecular subtypes of small cell lung cancer, immune-related gene characteristics and efficacy.

Being tested
Cadonilimab
Keywords
Cardunilizumab, Small cell lung cancer
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CadonilimabDrug

    Also called AK104

    Cadonilimab (10mg/kg, administered on the first day of each cycle, Q3W, until there is no clinical benefit)+platinum-based chemotherapy or Cadonilimab (10mg/kg, administered on the first day of each cycle, Q3W, until there is no clinical benefit), Q3W, 4cycles), every 3 weeks (21 days) is a treatment cycle.

Study groups in NCT05901584
Study groupRoleWhat they receive
Cadonilimab (AK104) combined with chemotherapyExperimentalCadonilimab(10mg/kg, administered on the first day of each cycle, Q3W, until there is no clinical benefit)+platinum-based chemotherapy or Cadonilimab(10mg/kg, administered on the first day of each cycle, Q3W, until there is no clinical benefit), Q3W, 4cycles), every 3 weeks (21 days) is a treatment cycle
Receives: Drug: Cadonilimab

What is being measured

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

  1. Progression-free survival，PFS

    The time from the beginning of the patient's treatment to the disease progression or death for any reason.Based on RECIST v i I Assessed PFS

    Measured: Time Frame: The last subject completes at least 24 weeks of follow-up (or disease progression)

Secondary outcomes (3)

  1. Overall Survival,OS

    The time from the patient receiving treatment to the death of the patient for any reason,OS evaluated according to RECIST vi. I

    Measured: 3 years

  2. Objective Response Rate，ORR

    The proportion of patients whose tumor volume is reduced to 30% and can be maintained for more than 4 weeks,Based on RECIST v i I Assessed ORR

    Measured: The last subject completes at least 24 weeks of follow-up (or disease progression)

  3. Disease control rate,DCR

    Includes complete remission, partial remission, and stable disease maintained for more than 4 weeks as a percentage of patients with evaluable outcomes

    Measured: The last subject completes at least 24 weeks of follow-up (or disease progression

Timeline

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

  1. First posted13 Jun 2023
  2. Study start1 Jan 2023
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (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
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05901584
Sponsor's protocol ID
SAHZunyiMU
Status last verified
Jun 2023
First submitted
4 Jun 2023
Last updated
18 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pang X, Huang Z, Zhong T, Zhang P, Wang ZM, Xia M, Li B. Cadonilimab, a tetravalent PD-1/CTLA-4 bispecific antibody with trans-binding and enhanced target binding avidity. MAbs. 2023 Jan-Dec;15(1):2180794. doi: 10.1080/19420862.2023.2180794.

    PubMed 36872527

  • Chen C, Chen M, Bai Y, Li Y, Peng J, Yao B, Feng J, Zhou JG, Ma H. A Single-Arm Multi-Center Phase II Clinical Trial of Cadonilimab (anti-PD-1/CTLA-4) in Combination with or without Conventional Second-Line Treatment for Patients with Extensive Stage Small Cell Lung Cancer. Technol Cancer Res Treat. 2024 Jan-Dec;23:15330338241249690. doi: 10.1177/15330338241249690.

    PubMed 38706247

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cadonilimab in people with Immunotherapy and Second-line Treatment, run by Second Affiliated Hospital of Zunyi Medical University 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 15 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 18 Jun 2023. 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?

Results are not available in the source record.

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

Contact Hu Ma, Ph.D (18115068816 ext. 085127596113, mahuab@163.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 (time frame: Time Frame: The last subject completes at least 24 weeks of follow-up (or disease progression)). 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 NCT05901584, which also lists 2 linked publications.

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 18 Jun 2023.

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