NSCLC
Conditions
Interventions
Combination Therapy Group:Evo xidan resistance: intravenous drip, every three weeks for a drug delivery cycles, each cycle day 1 give 20 mg/kg
Vinorelbine: oral 40mg/ time, 3 times a week (Monday/Marc
Tumor assessment was performed every 8 weeks (7 days) after 48 weeks. Then survival and safety follow-up were conducted.
Sponsors
Shandong First Medical University Affiliated Tumor Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily provide written informed consent (ICF); 1. Voluntary signing of the written informed consent form (ICF); 2. Age >= 18 years at the time of enrollment, both genders are acceptable; 3. Patients with locally advanced (IIIB/IIIC stage) or metastatic (IV stage) squamous non-small cell lung cancer (NSCLC) that is not curable and cannot undergo radical concurrent/sequential radiotherapy and chemotherapy as diagnosed by histological or cytological examination (according to the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer 8th edition lung cancer TNM staging); 4. Have failed 1-line or more systemic treatment previously; 5. Have not received any cisplatin or tegafur-uracil; 6. Have at least one measurable lesion that is suitable for repeated accurate measurement; 7. Eastern Cooperative Oncology Group (ECOG) performance status score is 0-2; 8. Expected survival >= 3 months; 9. Toxicity from previous anti-tumor treatment has recovered to = 1.5 × 10^9/L (1,500/mm3) 2) Platelet count >= 100 × 10^9/L (100,000/mm3) 3) Hemoglobin >= 90 g/L (2) Kidney: 1) Calculated value of creatinine clearance rate (CrCl, Cockcroft-Gault formula) >= 50 mL/min Male CrCl (mL/min) = (140 - Age) × Weight (kg) / (Serum creatinine SCr (mg/dL) × 72) Female CrCl (mL/min) = (140 - Age) × Weight (kg) × 0.85 / (Serum creatinine SCr (mg/dL) × 72) 2) Urine protein = 28 g/L (4) Pancreas: 1) Serum amylase = 50% 11. For premenopausal women with reproductive potential, a pregnancy test must be done 7 days before starting treatment, and the serum pregnancy must be negative and non-lactating. All enrolled patients (regardless of gender) must use adequate and effective contraceptive methods throughout the treatment cycle and for 6 months after the end of treatment 12. The subjects are willing and able to comply with the scheduled visits, treatment plans, laboratory tests, and other requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Histological or cytological pathology confirms the presence of small cell carcinoma components, or the main component is adenocarcinoma; 2. Patients who are allergic to any excipient components of evosizumab and the chemotherapy drugs selected in this trial; 3. Within 4 weeks before the first administration or within 5 half-lives (whichever is shorter), patients have received systemic anti-tumor treatment (chemotherapy, immunotherapy, small molecule TKI drugs), have received palliative radiotherapy within 2 weeks, or have received non-specific immunomodulatory treatment (such as interleukins, interferons, thymosin, tumor necrosis factor, etc., excluding those used to treat thrombocytopenia, IL-11) within 1 week, or have received modern Chinese patent medicines or Chinese herbal medicines approved by NMPA with anti-tumor indications within 1 week; 4. Within 3 years before the first administration, diagnosed with other malignant tumors other than squamous NSCLC, and excluding patients with other malignant tumors that have been cured by local treatment, such as basal or skin squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ, etc.; 5. Symptomatic CNS metastasis patients with unstable nervous system or requiring an increase in steroid dosage to control CNS symptoms within 2 weeks before the first administration. If the patient is receiving corticosteroids for non-CNS-related reasons due to endocrine deficiency or tumor-related symptoms, the drug dosage must be stable or reduced by at least 5 days before the first administration; 6. Present or previously suffered from cancerous meningitis; 7. Imaging during the screening period shows that the tumor surrounds important blood vessels or has obvious necrosis and cavities, and the investigator determines that entering the study will cause bleeding risk; 8. Those who received >30 Gy of chest radiotherapy within 6 months before the first administration, those who received >30 Gy of non-chest radiotherapy within 4 weeks before the first administration, and those who received =3); 10. Have a history of non-infectious pneumonia/interstitial lung disease requiring systemic glucocorticoid treatment or have current non-infectious pneumonia; 11. Have clinically significant, uncontrolled heart disease, such as: (1) Poorly controlled hypertension with systolic blood pressure >=160 mmHg or diastolic blood pressure >=100 mmHg) (2) Ventricular arrhythmia or other arrhythmias that cannot be controlled by other drugs (3) QT interval (QTcF) >=470ms 12. Subjects who plan to receive or have received live vaccines within 30 days before the first administration; 13. Active infections, including positive human immunodeficiency virus antibody, active hepatitis B virus infection or hepatitis C virus infection; 14. History of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis related to antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis or glomerulonep
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Duration of Response (DoR);Time to Progression (TTP);Disease Control Rate (DCR);12-month PFS Rate;Overall Survival (OS);Safety; | — |
Countries
China
Contacts
Public ContactZhehai Wang; Xiao Han
Shandong First Medical University Affiliated Tumor Hospital
Outcome results
None listed