Initially unresectable stage III EGFR-positive non-small cell lung cancer
Conditions
Interventions
Intervention group:The dosage of saltuzumab lukang is 4mg/kg, administered intravenously, once every two weeks.
The dosage of osimertinib is 80 mg orally. Each cycle lasts for 4 weeks, once a day, and
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years and =1.5×10^9/L; platelet count (PLT) >=100×10^9/L; hemoglobin >=90 g/L. (2) Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =30 g/L; total bilirubin (TBIL) =50 mL/min (calculated using the standard Cockcroft-Gault formula). (4) Coagulation function: international normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) <=1.5×ULN. 9. For female subjects of childbearing potential and male subjects with partners of childbearing potential, they must agree to use effective medical contraception from the signing of the informed consent until 6 months after the last dose. 10. Subjects voluntarily participate in this study, sign the informed consent form, and are able to comply with the scheduled visits and related procedures as required by the protocol.
Exclusion criteria
Exclusion criteria: 1. Patients who have received any prior systemic antitumor therapy for NSCLC, including surgery, local radiotherapy, cytotoxic drugs, targeted therapy, immunotherapy, or traditional Chinese medicine therapy, etc. 2. Patients who require the use of strong CYP3A4 inhibitors or inducers within 2 weeks before the first dose and during the study period; all subjects must avoid concomitant use of any drugs, herbal supplements, and/or intake of foods known to induce CYP3A4. 3. History of other malignancies within 3 years before dosing (excluding tumors cured by local therapy, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical carcinoma in situ, etc.). 4. Presence of any of the following cardiovascular or cerebrovascular diseases or risk factors: (1) Myocardial infarction, unstable angina, acute or persistent myocardial ischemia, class 3 or 4 heart failure (according to the New York Heart Association [NYHA] classification), symptomatic or poorly controlled severe arrhythmias, cerebrovascular accident, transient ischemic attack, or other serious cardiovascular or cerebrovascular diseases within 6 months before dosing; (2) History of myocardial diseases such as myocarditis, primary cardiomyopathy, or specific cardiomyopathy; (3) Any deep vein thrombosis (if stabilized for >=2 weeks with low-molecular-weight heparin or equivalent therapy, enrollment may be allowed), peripheral arterial thromboembolic events, pulmonary embolism, or other serious thromboembolic events within 3 months before dosing; (4) Major vascular diseases that may be life-threatening, such as aortic aneurysm or aortic dissecting aneurysm, or requiring surgery within 6 months before dosing. 5. Uncontrolled systemic diseases as judged by the investigator: (1) Poorly controlled diabetes (fasting blood glucose >=10 mmol/L on two consecutive measurements); (2) Poorly controlled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg); (3) Clinically significant pleural effusion, pericardial effusion, or ascites requiring repeated drainage (>1 time/week). 6. Clinically severe pulmonary impairment due to concurrent pulmonary diseases, including but not limited to any underlying pulmonary condition (e.g., pulmonary embolism within 3 months before dosing, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory disease that may affect the lungs (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.). 7. Subjects with active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulceration, gastrointestinal perforation, intra-abdominal abscess, or acute gastrointestinal bleeding. 8. Active autoimmune disease requiring systemic treatment within the past 2 years, including disease-modifying agents, immunosuppressants, or systemic corticosteroids (>10 mg/day prednisone or equivalent). Hormone replacement therapy, such as thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency, is not considered systemic therapy; subjects receiving systemic corticosteroids >10 mg/day prednisone or other immunosuppressive drugs within 2 weeks before dosing. 9. Known active pulmonary tuberculosis. Subjects with suspected active pulmonary tuberculosis must be clinically evaluated to rule it out. 10. History o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The dosage of saltuzumab lukang is 4mg/kg, administered intravenously, once every two weeks. The dosage of osimertinib is 80 mg orally. Each cycle lasts for 4 weeks, once a day, and it is advisable to administer it at the same time every day as much as possible.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate event-free survival (EFS) ;R0 resection rate;Security;Overall survival (OS);The rate of major pathological response (MPR);Pathological complete response (pCR) rate; | — |
Countries
China
Contacts
Public ContactYang Fan
Peking University People's Hospital
Outcome results
None listed