Advanced non-small cell lung cancer
Conditions
Interventions
experimental group:Subcutaneous injection of enverylumab combined with oral administration of vinorelbine
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily participated in this study, were able to sign the informed consent form, and had good compliance; 2. Locally advanced (stage IIIB or IIIC, inoperable or unresectable, or intractable with no radiotherapy options) or metastatic (stage IV) NSCLC confirmed by histological or cytological examination; 3. Negative for EGFR/ALK gene mutations; 4. At least one measurable lesion; 5. No previous systemic treatment; 6. Age = 70 years and ECOG PS >= 1, or 65 years = 2; 7. Expected survival period >= 3 months; 8. Major organ functions are satisfactory and meet the following criteria: 1) Complete blood count (without blood transfusion or the use of hematopoietic growth factor drugs in the last 14 days): Hemoglobin (Hb) >= 90 g/L; Absolute Neutrophil Count (ANC) >= 1.5 × 10^9/L; Platelet (PLT) >= 100 × 10^9/L; 2) Biochemical tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) = 60 mL/min; 3) Urinalysis: Urinary protein = 2, then the 24-hour urinary protein quantification must show protein <= 1 g; 4) Coagulation function: Activated Partial Thromboplastin Time (APTT), International Normalized Ratio (INR), Prothrombin Time (PT) <= 1.5 × ULN; 5) Thyroid function is normal, defined as Thyroid-Stimulating Hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, participants with total T3 (or FT3) and FT4 within the normal range may also be included; 9. Participants of childbearing potential must use appropriate contraceptive methods during the study and for 120 days after its completion, with a negative serum pregnancy test within 7 days prior to enrollment, and must not be lactating.
Exclusion criteria
Exclusion criteria: 1. Participants who have had other malignant tumors within 5 years before the start of this study or currently have other malignant tumors simultaneously; 2. Participants with any severe and/or uncontrolled diseases; 3. Participants with uncontrolled blood pressure (systolic blood pressure = 140 mmHg or diastolic blood pressure >= 90 mmHg); 4. Participants with uncontrolled cardiac clinical symptoms or diseases, such as: (1) NYHA class 2 or above heart failure; (2) unstable angina pectoris; (3) myocardial infarction within 1 year; (4) patients with clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 5. Participants with active infections or unexplained fever > 38.5°C during the screening period or before the first dose (fever caused by the tumor as judged by the investigator is acceptable for inclusion); 6. Participants with objective evidence of a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or severely impaired lung function; 7. Participants with acute or chronic active hepatitis B (HBsAg or HBcAb positive patients need to undergo HBV DNA testing. If the HBV DNA copy number is 10 mmol/L); 10. Participants with clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction; 11. Participants who have undergone major surgery, incisional biopsy, or significant traumatic injury within 28 days before the start of the study treatment, or have long-term non-healing wounds or fractures; 12. Participants who have experienced severe arterial or venous thrombotic events within 6 months before the start of the study treatment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, etc.; 13. Participants with a history of drug abuse of psychotropic substances and inability to quit or have mental disorders; 14. Participants who have received previous tumor treatment; 15. Participants with uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage (judged by the investigator); 16. Participants with known central nervous system metastases and/or carcinomatous meningitis; 17. Participants with a history of live attenuated vaccine administration within 14 days before the start of the study treatment or plan to receive live attenuated vaccines during the study; 18. Participants with active autoimmune diseases requiring systemic treatment (such as disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years before the start of the study treatment, except for replacement therapy (such as thyroid hormone, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, etc.); 19. Participan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival,pfs; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate,ORR;Duration of relief,DOR;Overall survival,OS; | — |
Countries
China
Contacts
Public ContactZhou Chengzhi
Guangzhou Medical University Respiratory Health Research Institute
Outcome results
None listed