Lung cancer
Conditions
Interventions
Experimental group:Ivonescimab in combination with chemotherapy.
Sponsors
North China University of Science and Technology Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The participant has been thoroughly informed about the study and has voluntarily signed the informed consent form (ICF). 2. Age >= 18 years, with no restriction on gender. 3. An expected survival of more than 3 months. 4. Presence of at least one measurable lesion as defined by RECIST v1.1. 5. Histologically or cytologically confirmed Stage IV metastatic or recurrent NSCLC with liver metastases, according to the 8th edition of the TNM classification by the International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC). 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0–1. 7. Patients who have previously received platinum-based adjuvant or neoadjuvant chemoradiotherapy, or radical chemoradiotherapy for advanced disease, and whose disease progression occurred more than 6 months after their most recent treatment, are eligible to participate in this study. 8. Adequate hematologic function, defined as: absolute neutrophil count (ANC) >= 1.5 × 10^9/L, platelet count >= 100 × 10^9/L, and hemoglobin >= 90 g/L (with no blood transfusions in the preceding 7 days). 9. Adequate liver function, defined as: total bilirubin = 50 mL/min, and urine protein < 2+ or 24-hour urine protein < 1.0 g. 11. Adequate coagulation function, defined as: international normalized ratio (INR) or prothrombin time (PT) <= 1.5 × ULN. If the participant is receiving anticoagulant therapy, the INR/PT should remain within the intended therapeutic range of the anticoagulant. 12. Women of childbearing potential must test negative for pregnancy within 7 days prior to initiating treatment. Both female and male participants of childbearing potential must use reliable contraceptive methods (e.g., intrauterine device, oral contraceptives, or condoms) from the start of the study until 30 days after study completion. Male participants are required to use condoms during the same period. 13. Able to comply with scheduled follow-up visits and adhere to the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Currently participating in another interventional clinical study. 2. Diagnosis of large cell carcinoma or mixed-type lung cancer that includes a small cell lung cancer component. 3. Prior exposure to any immunotherapy targeting tumor immune mechanisms (e.g., immune checkpoint inhibitors such as anti-PD-1/L1 or anti-CTLA-4 antibodies, immune checkpoint agonists such as ICOS, CD40, CD137, GITR, or OX40 antibodies, or any form of immune cell therapy). 4. Known allergy or hypersensitivity to any study drug or its excipients. 5. A history of severe bleeding tendency or coagulopathy; or clinically significant bleeding within 1 month before the first dose, including but not limited to gastrointestinal bleeding or hemoptysis (defined as coughing up >=1 teaspoon of fresh blood or blood clots, or hemoptysis without sputum—note that blood-tinged sputum is allowed), or significant epistaxis (excluding minor nosebleeds or retracted nasal bleeding). Patients whose screening imaging shows tumor encasement of major blood vessels or obvious necrosis/cavitation deemed to carry a high risk of hemorrhage (according to the investigator’s judgment) are also excluded. Likewise, patients with centrally located, cavitary squamous NSCLC at high risk of bleeding are excluded. Continuous use of antiplatelet or anticoagulant therapy within 10 days before the first dose is not permitted. 6. Tumor invasion of critical adjacent organs or vessels (such as the aorta, heart/pericardium, superior vena cava, trachea, or esophagus), presenting a risk of esophagotracheal or esophagopleural fistula as judged by the investigator. 7. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage. (Patients who do not require drainage or whose drainage frequency is less than once per month may be enrolled.) 8. Symptomatic brain metastases, leptomeningeal metastases, or spinal cord compression. 9. A history of non-infectious pneumonitis/interstitial lung disease requiring systemic corticosteroids, or current non-infectious pneumonitis. 10. Severe comorbidities (e.g., severe pulmonary or cardiac diseases). Any history of arterial thrombosis, embolism, or ischemia (including myocardial infarction, unstable angina, stroke, or transient ischemic attack) within 6 months before the start of study treatment. Any history of deep vein thrombosis, pulmonary embolism, or other severe thromboembolic events within 3 months before the start of study treatment. (Thrombosis associated with an implanted intravenous access port or catheter, or superficial venous thrombosis, is not considered a "severe" thromboembolic event.) 11. A history of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome-related vascular thrombosis, Wegener’s granulomatosis, Sjögren’s syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Subjects with autoimmune-related hypothyroidism who are on a stable dose of thyroid hormone replacement are eligible. Subjects with type 1 diabetes controlled by a stable insulin regimen are also eligible. 12. Active systemic infection, including tuberculosis (diagnosed according to local clinical practice, e.g., history, physical examination, imaging, and TB testing), hepatitis B (HBsAg positive with HBV DNA >= 1000 cps/mL or per local reference values), hepatitis C, or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Disease Control Rate;Duration of Response;Progression-Free-Survival Time; | — |
Countries
China
Contacts
Public ContactJia Jinghao
North China University of Science and Technology Affiliated Hospital
Outcome results
None listed