non-small cell lung cancer
Conditions
Interventions
Experimental Group:Envolizumab first-line treatment
Sponsors
The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily join the study and sign an informed consent form, have good compliance and cooperate with follow-up; 2. Aged >= 70 years; 3. According to the 8th edition of the TNM staging classification of lung cancer by the International Association for the Study of Lung Cancer and the United States Joint Committee on Cancer Classification, locally advanced stage (IIIB/IIIC) with inoperable treatment confirmed by histology or cytology and unable to receive radical concurrent radiotherapy and chemotherapy, Patients with metastatic or recurrent (stage IV) NSCLC; 4. According to the evaluation criteria for the efficacy of solid tumors (RECIST version 1.1), there is at least one imaging measurable lesion; 5. Have not received any systemic anti-tumor therapy for advanced/metastatic diseases in the past. For patients who have previously received platinum-containing adjuvant/neoadjuvant chemotherapy, or who have received radical radiotherapy and chemotherapy for advanced disease, if the disease progresses or relapses and the interval between the end of the last chemotherapy drug treatment is at least 6 months, they are allowed to be included in this study 6. Archived tumor tissue samples or newly obtained (without anti-tumor treatment since the biopsy) core or tumor lesions (not receiving radiotherapy) excised biopsy tissue have been provided. Formalin-fixed and paraffin-embedded (FFPE) tissue blocks are better than slices. The newly obtained biopsy tissue is better than the archived tissue, and the tissue samples are tested by immunohistochemistry for PD-L1>=50%; 7. ECOG PS 0-1 points; 8. Expected survival time >= 3 months; 9. Sufficient organ function, subjects need to meet the following laboratory indicators before enrollment: (1) Routine blood examination: 1) The absolute value of neutrophils (ANC) >= 1.5 x 10^9/L when no granulocyte colony stimulating factor is used in the past 14 days; 2) In the case of no blood transfusion in the past 14 days, platelets >= 100 x 10^9/L; 3) In the past 14 days without blood transfusion or using erythropoietin, hemoglobin >= 90g/dL; (2) Liver and kidney function: 1) Total bilirubin = 45 ml/min, urine routine test results show urine protein =2+, 24-hour urine collection and 24-hour urine protein quantitative < 1g should be performed; (3) Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) <= 1.5 times ULN; (4) Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH is out of the normal range, subjects whose total T3 (or FT3) and FT4 are within the normal range can also be included in the group; (5) The myocardial enzyme spectrum is within the normal range (if the investigator comprehensively judges that the simple laboratory abnormality is not clinically significant, it is also allowed to be included in the group); 10. If there is a risk of conception, all subjects (whether male or female) need to adopt a low annual failure rate during the entire treatment period until 120 days after the last study drug administ
Exclusion criteria
Exclusion criteria: 1. Patients with known EGFR sensitive mutations or ALK rearrangements; 2. Subjects with active central nervous system (CNS) metastasis, if the subjects CNS metastasis can be adequately treated, and the subjects neurological symptoms can be restored to baseline levels at least 2 weeks before enrollment (with CNS Except for treatment-related residual signs or symptoms), you can participate in the study. In addition, the subject must also be a subject who does not use corticosteroids, or receives a steady or gradually decreasing dose of prednisone (or equivalent) <= 10 mg/day; 3. Have received systemic systemic treatment with anti-lung cancer indications Chinese patent medicines or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural fluid) within 2 weeks before the first administration; 4. The subject has previously or simultaneously suffered from other malignant tumors (except for cured skin basal cell carcinoma and cervical carcinoma in situ); 5. Suffer from a known mental illness or substance abuse disease, which will interfere with the cooperation with research requirements. 6. Are currently participating in interventional clinical research treatment, or have received other research drugs or used research devices within 4 weeks before the first administration; 7. Active autoimmune diseases that require systemic treatment (such as the use of disease-relieving drugs, glucocorticoids or immunosuppressive agents) occurred within 2 years before the first administration. Alternative therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments; 8. Are receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first administration of the study; Note: The use of physiological doses of glucocorticoids (<=10 mg/day prednisone or equivalent drugs) is allowed; 9. Those who are known to be allergic to the active ingredients or excipients of the drug envolimab in this study; 10. Before starting treatment, have not fully recovered from toxicity and/or complications caused by any intervention (ie, <= Grade 1 or reach baseline, excluding fatigue or hair loss); 11. Known human immunodeficiency virus (HIV) infection history (ie HIV 1/2 antibody positive); 12. Untreated active hepatitis B (defined as HBsAg positive and the number of copies of HBV-DNA detected at the same time is greater than the upper limit of the normal value of the laboratory department of the research center); Note: Hepatitis B subjects who meet the following criteria can also be included in the group: (1) The HBV viral load before the first administration is less than 1000 copies/ml (200 IU/ml), and the subject should receive anti-HBV treatment during the entire study treatment period to avoid viral reactivation; (2) Subjects with anti-HBc(+), HBsAg(-), anti-HBs(-) and HBV viral load(-) do not need to receive preventive anti-HBV treatment, but need to closely monitor virus reactivation; 13. Active HCV infected subjects (HCV antibody positive and HCV-RNA level is higher than the lower limit of detection); 14. Live vaccine has been vaccinated within 30 days before the first administration (cycle 1, day 1); Note: It is allowed to receive inactivated virus vaccine for seasonal influenza within 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Countries
China
Contacts
Public ContactYe Feng
The First Affiliated Hospital of Xiamen University
Outcome results
None listed