Trial Title:
Cadonilimab (AK104) With or Without CT as 2rd Line Treatment for ES-SCLC
NCT ID:
NCT05901584
Condition:
Immunotherapy
Second-line Treatment
Conditions: Keywords:
Cardunilizumab
Small cell lung cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cadonilimab
Description:
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.
Arm group label:
Cadonilimab (AK104) combined with chemotherapy
Other name:
AK104
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
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.
Criteria for eligibility:
Criteria:
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 imaging
confirmation of extensive stage with measurable lesions.
3. 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):
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:
1. total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN).
2. alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5 × ULN,
if accompanied by liver metastases, then ALT and AST ≤ 5 × ULN
3. 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.
Exclusion Criteria:
1. Patients with previous use of cardunilizumab.
2. non-small cell lung cancer (including lung cancer with a mixture of small
cell and non-small cell carcinoma).
3. 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).
4. 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.
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, chronic
diarrhea, and intestinal obstruction may experience challenges with oral
drug 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
less than 2 months.
9. Patients with any severe and/or uncontrolled disease, including:
1. Patients with poorly controlled blood pressure (systolic blood pressure ≥ 150
mmHg and diastolic blood pressure ≥ 100 mmHg).
2. 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.
3. Active or uncontrolled serious infection (≥ CTC AE grade 2 infection).
4. Cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis
requiring antiviral therapy.
5. Renal failure requiring hemodialysis or peritoneal dialysis.
6. 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.
7. poorly controlled diabetes (fasting blood glucose (FBG) >10 mmol/L).
8. urine routine suggesting urine protein ≥++ and confirmed 24-hour urine protein
quantification >1.0 g.
9. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Second Affiliated Hospital of Zunyi Medical University
Address:
City:
Guizhou
Zip:
563000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianguo Zhou, doctor
Phone:
18311543939
Phone ext:
18311543939
Email:
jianguo.zhou@zmu.edu.cn
Start date:
January 1, 2023
Completion date:
December 2024
Lead sponsor:
Agency:
Second Affiliated Hospital of Zunyi Medical University
Agency class:
Other
Collaborator:
Agency:
Guizhou Provincial People's Hospital
Agency class:
Other
Collaborator:
Agency:
The First People's Hospital of Zunyi
Agency class:
Other
Collaborator:
Agency:
Guizhou Tongren People's Hospital
Agency class:
Other
Collaborator:
Agency:
The People"s Hospital of Xingyi
Agency class:
Other
Collaborator:
Agency:
The Second Affiliated Hospital of Guizhou Medical University
Agency class:
Other
Source:
Second Affiliated Hospital of Zunyi Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05901584
