Status and phase
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About
The goal of this clinical trial is to investigate the efficacy, safety and tolerability of Ivonescimab combined with Cadonilimab and chemotherapy in extensive-stage small cell lung cancer patients. And also explore the potential biomarkers for predicting the efficacy of Ivonescimab combined with Cadonilimab for extensive-stage small cell lung cancer.
Enrollment
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Volunteers
Inclusion criteria
Exclusion criteria
Currently participating in interventional clinical research treatment;
For Arm 1: a) Prior immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1 /L1 antibody, anti-CTLA-4 antibody, anti-TIGIT antibody, anti-LAG-3 antibody, etc.), immune checkpoint agonists (e.g. ICOS, CD40, CD137, GITR, OX40 antibody, etc.), immune cell therapy, and any treatment targeting the tumor immune mechanism; b) previous systemic anti-angiogenic therapy, including but not limited to bevacizumab small molecule TKI, etc. For Arm 2:
a) PD-1/L1 inhibitor crossover therapy: after the failure of PD-1/L1 inhibitor combined with chemotherapy, the chemotherapy regimen was changed and the original PD-1/L1 inhibitor was given again. b) Prior immunotherapy other than PD-1/L1 inhibitors, including immune checkpoint inhibitors (e.g., anti-TIGIT antibody, anti-LAG-3 antibody, etc., anti-CTLA-4 monoclonal antibody), immune checkpoint agonists (e.g. ICOS, CD40, CD137, GITR, OX40 antibody, etc.), immune cell therapy, and any treatment targeting the mechanism of tumor immune action. c) previous treatment with a taxol chemotherapeutic agent. d) previous systemic anti-angiogenic therapy, including but not limited to bevacizumab, small molecule TKI, etc.
Imaging during the screening period showed that the tumor was surrounded by important blood vessels or had obvious necrosis or cavities, and the investigator judged that the entry of the study would cause bleeding risk.
active autoimmune disease requiring systemic treatment within the past 2 years (e.g., with disease-modifying medications, corticosteroids, immunosuppressants). Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) is not considered a systemic treatment.
history of noninfectious pneumonia/interstitial lung disease requiring systemic glucocorticoid treatment or current noninfectious pneumonia.
History of brain stem, meningeal metastasis, spinal cord metastasis or compression.presence of active central nervous system (CNS) metastases; Participants who had previously been treated for brain metastases (e.g., surgery, radiotherapy) were allowed if they were clinically stable for at least two weeks after treatment (calculated from the time of the first administration of the study drug) and if corticosteroids were discontinued 7 days before the administration of the study drug. Participants with untreated, asymptomatic brain metastases (i.e., no neurologic symptoms, no need for corticosteroids, no brain metastases measuring >1.5 cm in the greatest dimension, and no substantial premetastatic edema) were eligible for enrollment
presence of current uncontrolled coexisting medical conditions, including but not limited to decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorder, severe active peptic ulcer disease, or gastritis, or mental illness/social condition that would limit compliance with study requirements or affect the participant's ability to provide written informed consent;
previous history of myocarditis, cardiomyopathy, and malignant arrhythmia. The presence of unstable angina, myocardial infarction, congestive heart failure (New York Heart Association functional class 2 or higher), or vascular disease (e.g., aortic aneurysm at risk for rupture) that required hospitalization within 12 months before the first dose of the study drug or other cardiac impairment (e.g., uncontrolled arrhythmias, myocardial ischemia) that could affect the safety evaluation of the study drug; The patient had a history of esophagogastric varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months before the first dose of medication. Any arterial thromboembolic event, venous thromboembolic event of NCI CTCAE version 5.0 or higher, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy occurred 6 months before the first dose. An acute exacerbation of chronic obstructive pulmonary disease occurred within 1 month before the first dose, except for infusion-related thrombosis that had occurred for more than 4 weeks.
history of severe bleeding tendency or coagulopathy; Clinically significant bleeding symptoms within 1 month before the first dose of medication, including but not limited to gastrointestinal bleeding, hemoptysis (defined as coughing up or coughing up ≥1 teaspoon of blood or small blood clot or only coughing up blood without sputum, and those with blood in sputum were allowed), nasal bleeding (excluding epistaxis and retraction of nasal bleeding); Continuous antiplatelet or anticoagulant therapy had been administered within 10 days before the first dose.
lack of resolution of toxicity from prior antineoplastic therapy, defined as failure to return to NCI CTCAE version 5.0 grade 0 or 1 or levels specified in the inclusion/exclusion criteria, with the exception of alopecia. Subjects with irreversible toxicity that was not expected to worsen with study drug administration (e.g., hearing loss) may be enrolled after consultation with the medical monitor. Subjects with long-term radiation-induced toxicity that, in the judgment of the investigator, did not recover from, may be included in the study.
serious infection within 4 weeks before the first dose, including but not limited to coexisting conditions requiring hospitalization, sepsis, or severe pneumonia; Active infection (excluding antiviral therapy for hepatitis B or hepatitis C) that had received systemic anti-infective therapy within 2 weeks before the first dose.
history of immunodeficiency; HIV antibody positive; Long-term use of systemic corticosteroids or other immunosuppressive agents is ongoing.
Subjects with known active pulmonary tuberculosis should be excluded by clinical examination (e.g., sputum test, chest X-ray, etc.); Known active syphilis infection.
history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
presence of pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage.
subjects with active hepatitis B (HBsag-positive and HBV-DNA > 500 copies /ml or higher than the lower limit of detection); Subjects with active hepatitis C (HCV antibody-positive).
had a major surgical procedure or major trauma within 30 days before or within 30 days after the first dose (at the discretion of the investigator); Minor local procedures (excluding peripherally inserted central catheters and intravenous-access ports) had been performed within 3 days before the first dose.
received live attenuated influenza vaccine within 30 days before the first dose or plan to receive live attenuated influenza vaccine during the study and cannot receive live attenuated influenza vaccine within 90 days after treatment after the last dose of the study drug.
known allergy to any component of any study drug; A history of severe hypersensitivity reactions to other monoclonal antibodies was known.
known history of mental illness, substance abuse, alcohol or drug abuse.
pregnant or lactating women.
The presence of any past or current medical conditions, treatments, or laboratory abnormalities that may confound the results of the study, preclude full participation in the study, or participation in the study may not be in the best interest of the subject
Primary purpose
Allocation
Interventional model
Masking
70 participants in 2 patient groups
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Central trial contact
Li Wang, Doctor
Data sourced from clinicaltrials.gov
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