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

Last updated: June 14, 2023
Sponsor: Second Affiliated Hospital of Zunyi Medical University
Overall Status: Active - Recruiting

Phase

2

Condition

Chemotherapy

Cancer

Vaccines

Treatment

Cadonilimab

Clinical Study ID

NCT05901584
SAHZunyiMU
  • Ages 18-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients voluntarily participate in this study by signing an informed consent form.
  2. Pathologically confirmed diagnosis of small cell lung cancer, with imagingconfirmation of extensive stage with measurable lesions.
  3. Patients who have been treated with at least one line of systemic platinum-containingchemotherapy 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):
  1. Hemoglobin (HB) ≥ 90g/L.
  2. Absolute central granulocyte value (ANC) ≥ 1.5×109/L.
  3. Platelets (PLT) ≥75×109/L. ②Biochemistry needs to meet the following criteria:
  4. total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN).
  5. alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5 × ULN, ifaccompanied by liver metastases, then ALT and AST ≤ 5 × ULN
  6. serum creatinine (Cr) ≤ 1.5×ULN or creatinine clearance ≥ (CCr) 60 ml/min. ③Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ lowlimit of normal (50%). 6.Female participants of reproductive age must use contraception methods such asIUD, pill, or condom during the study period and for 6 months after. Maleparticipants must also agree to use contraception during the study period and for 6 months after. Additionally, female participants must have a negative serum orurine pregnancy test within 7 days prior to study entry and should not bebreastfeeding.

Exclusion

Exclusion Criteria:

  1. Patients with previous use of cardunilizumab.
  2. non-small cell lung cancer (including lung cancer with a mixture of smallcell and non-small cell carcinoma).
  3. Patients with other types of cancer that occurred within the past 5 years orare currently present, with the exception of treated cervical carcinoma insitu, non-melanoma skin cancer, and superficial bladder tumors that have notinvaded the basement membrane (Ta, Tis, and T1).
  4. Systemic antitumor therapy, including cytotoxic therapy, signal transductioninhibitors, immunotherapy, within 4 weeks prior to enrollment or plannedduring the current study dosing period (or have used mitomycin C within 6weeks prior to treatment with the trial drug). Have had extended fieldradiotherapy (EF-RT) within 4 weeks prior to subgroup or have hadfield-limited radiotherapy to the tumor lesion to be evaluated within 2weeks prior to subgroup.
  5. Unremitted toxic reactions due to any prior treatment above CTCAE grade 1,excluding alopecia and neurotoxicity ≤ grade 2 due to oxaliplatin.
  6. Individuals with various factors such as difficulty swallowing, chronicdiarrhea, and intestinal obstruction may experience challenges with oraldrug administration.
  7. with pleural effusion or ascites causing respiratory syndrome (≥ CTCAE grade 2 dyspnea).
  8. Patients with brain metastases with symptoms or symptoms controlled for lessthan 2 months.
  9. Patients with any severe and/or uncontrolled disease, including:
  10. Patients with poorly controlled blood pressure (systolic blood pressure ≥ 150mmHg and diastolic blood pressure ≥ 100 mmHg).
  11. Patients with myocardial ischemia of grade I or higher, myocardial infarction,arrhythmias (including QTc ≥ 480 ms), and congestive heart failure of grade 2 orhigher (categorized according to the New York Heart Association (NYHA)classification) are included.
  12. Active or uncontrolled serious infection (≥ CTC AE grade 2 infection).
  13. Cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitisrequiring antiviral therapy.
  14. Renal failure requiring hemodialysis or peritoneal dialysis.
  15. This refers to a medical history of immunodeficiency, which can be acquiredthrough HIV or other diseases, or congenital in nature. It also includes ahistory of organ transplantation.
  16. poorly controlled diabetes (fasting blood glucose (FBG) >10 mmol/L).
  17. urine routine suggesting urine protein ≥++ and confirmed 24-hour urine proteinquantification >1.0 g.
  18. Patients with seizures and requiring treatment. 10. Participants who haveundergone major surgical treatment, incisional biopsy, or significant traumaticinjury 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 vascularperimeter or who, in the judgment of the investigator, are at high risk of fatalhemorrhage due to tumor invasion of a critical vessel during the follow-up study. 12.Patients with any physical signs or history of bleeding, regardless ofseverity; 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 withinthe past 6 months, including cerebrovascular accidents (including temporaryischemic attacks), deep vein thrombosis, and pulmonary embolisms, should takecaution. 14.Individuals with a history of psychotropic substance abuse or psychiatricdisorders who are unable to abstain. 15.having participated in clinical trials of other antineoplastic drugs withinfour weeks. 16.Patients with concomitant diseases that are deemed to pose a significant riskto their safety or may hinder their ability to complete the study, as determinedby the investigator, will be excluded.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Cadonilimab
Phase: 2
Study Start date:
January 01, 2023
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • The Second Affiliated Hospital of Zunyi Medical University

    Guizhou, ZunYi 563000
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.