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

NCT05901584 | Unknown Phase 2 DMC

• 1 other identifier: SAHZunyiMU
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Immunotherapy; Second-line Treatment

Keywords

Cardunilizumab; Small cell lung cancer

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (3)

• Overall Survival,OS

  3 years

• Objective Response Rate，ORR

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

• Disease control rate,DCR

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

Study Arms (1)

Cadonilimab (AK104) combined with chemotherapy

EXPERIMENTAL

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

Drug: Cadonilimab

Interventions

Cadonilimab DRUG

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.

Also known as: AK104

Cadonilimab (AK104) combined with chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• years of age; ECOG PS score: 0 to 1; expected survival greater than 3 months.
• Major organ function within 7 days prior to treatment, meeting the following criteria:
• Blood test criteria (in 14-day untransfused state):
• 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:
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• 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%).
• 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.

You may not qualify if:

• 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.
• 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:
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• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Zunyi Medical University: lead
• Guizhou Provincial People's Hospital: collaborator
• The First People's Hospital of Zunyi: collaborator
• Guizhou Tongren People's Hospital: collaborator
• The People"s Hospital of Xingyi: collaborator
• The Second Affiliated Hospital of Guizhou Medical University: collaborator

Study Sites (1)

The Second Affiliated Hospital of Zunyi Medical University

Guizhou, ZunYi, 563000, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 36872527 BACKGROUND

• 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.

  PMID: 38706247 DERIVED

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hu Ma, Ph.D

  The Second Affiliated Hospital of Zunyi Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hu Ma, Ph.D

CONTACT

18115068816; mahuab@163.com

Jianguo Zhou, Ph.D

CONTACT

18311543939; jianguo.zhou@zmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2023
• First Posted: June 13, 2023
• Study Start: January 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)