Non-small Cell Lung Cancer
Conditions
Interventions
Treatment group:NK cell combined with PD-1 antibody
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Age = 18 years old. (2) Histological examination confirmed that there is currently a locally advanced (IIIB/IIIC phase) or metastatic NSCLC (squamous or non-squamous). (3) Disease progression occurred after platinum-based chemotherapy in the previous line, and measurable lesions existed according to RECIST v1.1. (4) Patients must be able to provide fresh or archived tumor tissue and pathology reports. Non-squamous NSCLC must be able to provide a report that is confirmed to be wild-type EGFR by tissue-based assays. (5) ECOG PS = 1. (6) The vital organs are fully functional, and the following results are obtained for each laboratory indicator (accepting the results of the examinations made within = 28 days before randomization): Cardiac ultrasound indicates a cardiac ejection fraction = 50%; blood oxygen saturation = 90%; Absolute neutral cell count (ANC) = 1.5 x 10^9/L, platelet count = 100 x 10^9/L, hemoglobin = 90g/dL; Creatinine (Cr) = 2.5 times normal range; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 times normal range, total bilirubin (TBIL) = 1.5 times normal range. (7) No contraindications for apheresis and cell separation. (8) Male or female with fertility needs to agree to take effective contraceptive measures during the study period and at least 120 days after the end of medication. (9) A written informed consent can be provided and the research requirements are understood and followed.^
Exclusion criteria
Exclusion criteria: (1) Previously received immunological checkpoint inhibitors targeting PD-1, PD-L1 or CTLA-4 and other immunotherapies (including but not limited to interferon or IL-2, chimeric antigen receptor T Cells, vaccines, etc.). (2) NSCLC with EGFR gene mutation or ALK gene translocation. (3) The toxicity caused by previous anticancer treatment has not recovered to baseline level or returned to stability (except for hair loss, rash, pigmentation or specific laboratory abnormalities). (4) A history of severe allergic reactions to other monoclonal antibodies. (5) History of interstitial pneumonia, non-infectious pneumonia or uncontrolled systemic diseases, including diabetes, hypertension, and pulmonary fibrosis. (6) Clinically severe pericardial effusion. (7) Pleural effusion or ascites that is clinically uncontrolled and requires thoracentesis or abdominal puncture drainage within 2 weeks prior to randomization. (8) Active pia mater disease or unstable brain metastasis. (9) Surgical major surgery, open biopsy or severe traumatic injury was performed = 28 days prior to randomization, or major surgical procedures were expected during the study. (10) Other malignant tumors other than NSCLC (except for surgically resected non-melanoma skin cancer, fully treated cervical carcinoma in situ, cured local prostate cancer, fully treated low-grade bladder cancer, Curatively treated breast ductal carcinoma in situ, or a malignant tumor diagnosed 2 years ago, but there is currently no evidence of disease in the absence of treatment = 2 years prior to randomization). (11) Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral treatment, including HIV, HBV, HCV infection. (12) Active autoimmune disease or a history of autoimmune disease but may recur. (13) Subjects who require systemic treatment with corticosteroids or other immunosuppressive agents within 14 days prior to randomization. (14) Those who have undergone organ transplantation or hematopoietic stem cell transplantation. (15) Any live vaccine against infectious diseases (eg, influenza, chickenpox, etc.) was used within 28 days prior to randomization. (16) Meet any of the following cardiovascular disease criteria: Evidence of acute or positive myocardial ischemia; There are currently symptomatic pulmonary embolisms; Acute myocardial infarction occurred within =6 months before randomization; Has reached the New York Heart Association grading standard (see Appendix 5) 3 or 4 before randomization = 6 months Grade of heart failure; A =2 grade ventricular arrhythmia occurred within =6 months before randomization; A cerebrovascular accident (CVA) or transient ischemic attack (TIA) occurred within =6 months before randomization. (17) Pregnant and lactating women. (18) If the patient is unable to follow the study procedures, limitations, and requirements, the investigator believes that the patient is not allowed to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate;Overall Survival;Duration of Response; | — |
Countries
China
Contacts
Public ContactCui Jiuwei
The First Hospital of Jilin University
Outcome results
None listed