non-small cell lung cancer
Conditions
Interventions
A:Triprilimab combined with CIK
B:Triprilimab combined with CIK combined with chemotherapy
C:Chemotherapy combined with CIK
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Only those who meet all the following criteria can be enrolled in this study: 1. Patients with locally advanced (stage IIb / IIC), metastatic or recurrent (stage IV) NSCLC confirmed histologically or cytologically as inoperable and unable to receive radical concurrent chemoradiotherapy were confirmed to have at least one measurable lesion according to RECIST 1.1; 2. There were enough samples for genotyping and no sensitive gene mutation. Molecular typing: EGFR gene was negative by arms method; ALK fusion mutation was negative by Ventana immunohistochemistry (d5f3 antibody) or fish. The results of the second generation sequencing were also accepted; 3. Aged 18 to 75 years old; 4. Before randomization, patients must have PD-L1 positive tumor cells (defined as PD-L1 expression in >=1% of tumor tissues by the reference laboratory using Ventana sp263 PD-L1 IHC test results). Similarly, all patients must be able to receive fresh tumor biopsies during the screening process or to provide archived tumor samples obtained within 3 months prior to screening; 5. ECoG PS score: 0 ~ 1; the expected survival time is more than 3 months; 6. No systematic anti-tumor treatment for advanced diseases has been received in the past. Patients are allowed to receive adjuvant radiotherapy and chemotherapy in the past, but the interval between the recurrence of the disease and the last administration of chemotherapy must be at least 6 months; 7. The function of the main organs is normal, that is to say, it meets the following standards: (1) Hematopoiesis was defined as neutrophil count >=1.5x10^9/L, platelet count >=100x10^9/L, hemoglobin >=90 g/L [no blood transfusion or erythropoietin (EPO) dependence] within 7 days; Hb >=90g/L (no blood transfusion within 14 days); ANC >=1.5x10^9/L; PLT >=100x10^9/L; (2) Biochemical examination should meet the following standards: Bil =60ml/min; 4. Good coagulation function, INR and Pt <=1.5 ULN; if the subject was receiving anticoagulant therapy, Pt was within the scope of anticoagulant drugs; 5. women of childbearing age should be those who agree to use contraception (e.g. intrauterine device, contraceptive or condom) during the study period and within 6 months after the end of the study; if the serum or urine pregnancy test is negative within 7 days before the study enrollment, and they must be non lactating patients; and the male should agree to use contraception during the study period and within 6 months after the end of the study period; 6. patients volunteered to join the study, signed informed consent, and had good compliance.
Exclusion criteria
Exclusion criteria: 1. It was diagnosed as non-small cell lung cancer with EGFR sensitive mutation and ALK gene translocation. 2. Small cell lung cancer (including small cell carcinoma and non-small cell cancer mixed lung cancer); 3. Within 6 months, he has received any systematic anti-tumor treatment, including radiotherapy, chemotherapy, immunotherapy and traditional Chinese medicine treatment (excluding the treatment of malignant tumors with a previous radical cure and no recurrence and metastasis time >=5 years); 4. Patients with known symptomatic brain metastases, spinal cord compression, cancerous meningitis, or diseases of brain or pia mater found by CT or MRI examination at screening; 5. Patients with any severe and / or uncontrolled disease, such as: (1) unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months before randomization, serious uncontrollable arrhythmia; patients with unsatisfactory blood pressure control (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg); (2) active or uncontrolled severe infection; (3) liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; (4) poor control of diabetes mellitus (FBG > 10mmol/L); (5) urine routine examination indicated that urine protein >=+ +, and 24-hour urine protein quantity was more than 1.0 G; (6) active pulmonary tuberculosis, etc; (7) uncontrolled hypercalcemia (more than 1.5 mmol/L calcium ion or calcium greater than 12 mg/dL or corrected serum calcium greater than ULN), or symptomatic hypercalcemia requiring continued bisphosphonate therapy; (8) wounds or fractures that have not been cured for a long time; 6. Before the first medication, patients had arteriovenous thrombosis, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism; 7. Those who have a history of abuse of psychotropic drugs and can not quit or have mental disorders; 8. Have participated in clinical trials of other anti-tumor drugs within four weeks; have received immunotherapy, such as anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs, or another drug that stimulates or synergistically inhibits T-cell receptors (e.g., CTLA-4, OX-40, CD137); 9. Patients with a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 10. It is known that there are severe allergic reactions (>=grade 3) to active ingredients of PD1 / PDL1 mAb, pemetrexed, carboplatin and other test drugs; 11. Immunosuppressive drugs were used within 4 weeks before enrollment, excluding nasal, inhalation or other local glucocorticoids or physiological doses of systemic glucocorticoids (i.e. prednisone no more than 10 mg / day or other equivalent doses of other glucocorticoids); 12. Patients with known or suspected active autoimmune diseases (congenital or acquired), such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, thyroiditis, etc. (patients with vitiligo or asthma in childhood have been completely relieved, and patients with type I diabetes mellitus with good insulin control can also be included in the group); 13. Allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation is known; 14. There was a history of non infectious pneumonia requiring glucocorticoid treatment or current interst
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| physical examination;routine hematological examination;chest enhanced CT;transabdominal ultrasound;Brain enhanced magnetic resonance imaging;Bone scan;safety;ORR;PFS;DCR;OS; | — |
Countries
China
Contacts
Public ContactRunbo Zhong
Shanghai Chest Hospital
Outcome results
None listed