non-smallcelllungcancer
Conditions
Interventions
single-arm:Zimberelimab combined with Anlotnib
Sponsors
Fuzhou First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects were = 18 years old when they signed the informed consent form, both male and female. 2. Histologically or cytologically confirmed as stage IV non-small cell lung cancer (NSCLC). 3. Subjects must also progress after receiving any PD-1 or PD-L1 inhibitor (including cyparizumab) as one of their latest treatment regimen combinations, and must have at least 3 months of PFS in this treatment. Subjects must participate in the trial within 6 weeks after the last infusion of PD-1 or PD-L1 inhibitor. 4. EGFR, ROS1, RET, MET genes are negative; 5. According to the judgment of the attending doctor, it is suitable to receive arotinib treatment. 6. According to RECIST 1.1 standard, subjects must have measurable target lesions examined by CT or MRI. 7. ECOG PS score: 0-1. 8. Expected survival time = 3 months. 9. All screening laboratory tests shall be carried out according to the requirements of the protocol and within 14 days before the first administration. The values of laboratory tests conducted by screening must meet the following standards: 1) blood routine test: (no blood transfusion, G-CSF use, and drug correction within 14 days before screening) a) hemoglobin (HB) = 90g/L; b) Absolute neutrophil count (ANC) = 1.5 × 109/L c) Platelet count (PLT) = 100 × 109/L d) White blood cell count (WBC) = 4.0 × 109/L and = 15 × 109/L 2) Biochemical examination: (no blood transfusion or albumin within 14 days before screening) e) AST and ALT = 1.5 × ULN (= 5 if tumor liver metastasis exists × ULN) f)ALP=2.5 × ULN g)TBiL=1.5 × ULN h)ALB=30g/L i)Cr=1.5 × ULN, and creatinine clearance rate (CrCL) = 60mL/min (Cockcroft Gault formula); j)APTT=1.5 × ULN, while INR or PT = 1.5 × ULN (no anticoagulation treatment). 10. Women of childbearing age must carry out serum pregnancy test within 3 days before the first medication, and the result is negative. Women of childbearing age and male subjects whose partners are women of childbearing age must agree to use efficient contraception during the study period and within 180 days after the last administration of the study drug. 11. Volunteer to participate in clinical research and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. The subject has any active autoimmune disease or has a history of autoimmune disease (For example, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma in childhood has completely alleviated, without any intervention after adulthood can be included; subjects with asthma requiring medical intervention of bronchodilators cannot be included); 2. Subjects are using immunosuppressive agents, or systemic or absorbable local hormones to achieve the purpose of immunosuppression (dose>10mg/day prednisone or other therapeutic hormones), and continue to use them within 2 weeks before enrollment; 3. Severe allergic reaction to other monoclonal antibodies; 4. The subject had untreated central nervous system metastasis. Patients who have received brain or meningeal metastasis treatment in the past, if the clinical stability (MRI) has been maintained for at least 1 month, and have stopped systemic hormone treatment (dose>10mg/day prednisone or other effective hormones) for more than 2 weeks can be included 5. Imaging (CT or MRI) shows that the tumor invades large vessels or has unclear boundary with vessels; 6. Imaging (CT or MRI) shows that there is obvious pulmonary cavitary or necrotic tumor; Marginal adenocarcinoma with cavity can be considered as a group after discussion with the main investigator. 7. Patients with hypertension who cannot be well controlled after antihypertensive drug treatment (systolic blood pressure = 140mmHg or diastolic blood pressure = 90mmHg); 8. There are clinical cardiac symptoms or diseases that are not well controlled, such as: (1) heart failure above NYHA level 2 (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 9. Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg<2g/L), with bleeding tendency or receiving thrombolytic or anticoagulant treatment; 10. Routine urine test indicates that the urine protein is =++, or the 24-hour urine protein volume is verified to be = 1.0g; 11. Those who have previously received radiotherapy, chemotherapy and surgery, but after the completion of treatment (the last medication), less than 4 weeks before the study medication, and less than 5 half lives of oral targeted drugs; Patients whose adverse events (except hair loss) caused by previous treatment have not recovered to = CTCAE1 degree; 12. The ascites or pleural effusion with clinical symptoms need therapeutic puncture or drainage; 13. There was obvious cough blood or daily hemoptysis volume of half a teaspoon (2.5ml) or more within 2 months before randomization; 14. In the first 3 months of randomization, there were bleeding symptoms with significant clinical significance or a clear bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, fecal occult blood++or above at baseline, or vasculitis; 15. Arterial/venous thrombosis events occurred in the first 6 months of randomization, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, pulmonary embolism, etc; 16. Known heritability or Acquired bleeding and thrombotic tendency (such as hemophilic patients, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.); 17. The subject ha
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DOR;PFS;OS; | — |
Countries
CHINA
Contacts
Public ContactXiaoBing Huang
Fuzhou First Hospital
Outcome results
None listed