Non-Small Cell Lung Cancer
Conditions
Interventions
experimental group:oral Anlitinib and intravenous inject sintilimab according to the study protocol
control group:First line standard chemotherapy
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. According to the international association for the study of lung cancer and the American joint committee on cancer classification version 8 lung cancer TNM staging, histological or cytology confirmed not surgery and cannot accept radical chemoradiation locally advanced (III B/ C III period), metastatic or recurrent NSCLC patients, (IV) according to RECIST 1.1 standard confirmed with at least one measurable lesions. 2. Enough specimens are available for molecular typing. Molecular typing refers to EGFR gene mutation, which was clearly detected by ARMS method. ALK fusion mutation was confirmed by Ventana immunohistochemistry (D5F3 antibody).ROS1 fusion gene mutation was identified by RT-PCR. 3. Aged >= 18 years old and = 1.5 x 10^9 /L, platelet count >= 100 x 10^9 /L, and hemoglobin >= 90g/L [no transfusion or EPO dependence within 7 days] HB >= 90g/L (no blood transfusion within 14 days); ANC >= 1.5 x 10^9/L PLT >= 100 x 10^9/L (2) biochemical examination shall meet the following standards: BIL = 60ml/min Coagulation function was good, INR and PT <= 1.5 ULN.If subjects are receiving anticoagulant therapy, as long as PT is within the range of anticoagulant drug use; 7. Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the study;Negative serum or urine pregnancy test within 7 days before study enrollment, and must be a non-lactating patient;Men should agree to patients who must use contraception during the study period and within 6 months after the end of the study period. 8. Patients volunteered to participate in this study and signed informed consent, with good compliance.
Exclusion criteria
Exclusion criteria: Exclusion criteria: patients with any of the following items will not be enrolled in this study: 1. small cell lung cancer (including small cell cancer and non-small cell cancer mixed lung cancer); 2. have received any systemic anti-tumor therapy, including radiotherapy, chemotherapy, immunotherapy and traditional Chinese medicine therapy (except the previous radical cure for malignant tumors with no recurrence or metastasis >= 5 years); 3. patients with multiple factors affecting oral drugs (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 4. patients with known symptomatic brain metastasis, spinal cord compression, cancerous meningitis, or diseases of the brain or pia mater detected by CT or MRI during screening; 5. central type of cavernous squamous cell carcinoma or a patient with hemorrhagic symptoms or bleeding tendency assessed by the investigator. 6. there are no severe and/failed to control the disease, such as: (1) Unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months before randomization, and severe uncontrolled arrhythmias. Patients with poor blood pressure control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); (2) An active or uncontrolled serious infection; (3) Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; (4) Poor control of diabetes (fasting blood glucose (FBG) > 10mmol/L); (5) Urine routine indicated that urine protein >= ++, and confirmed 24-hour urine protein quantitative > 1.0g; (6) Active pulmonary tuberculosis; (7) Uncontrolled hypercalcemia (greater than 1.5 mmol/L of calcium or calcium greater than 12 mg/dL or adjusted serum calcium greater than ULN), or symptomatic hypercalcemia requiring continued bisphosphate treatment; (8) A wound or fracture that has not healed for a long time; 7. patients with bleeding tendencies (such as active gastrointestinal ulcers) or treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues;Small doses of warfarin (= grade 3) known to the active ingredients and/or any excipients of other experimental drugs such as cindizumab, pemetrix, carboplatin, etc; 13. immunosuppressive drugs were used within the first 4 weeks of enrollment, excluding local glucocorticoids by nasal spray, inhalation or other means or systemic glucocorticoids at physiological doses (i.e., no more than 10 mg/ d prednisone or equivalent doses of oth
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;DCR; | — |
Countries
china
Contacts
Public ContactYu Li
Qilu Hospital of Shandong University
Outcome results
None listed