Non-Small Cell Lung Cancer
Conditions
Interventions
Immunotherapy effective group vs immunotherapy ineffective group:Nil
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with aged >= 18 years; 2. Patients with definite diagnosis of NSCLC by histology / cytology; 3. Patients with imaging measurable focus and at least one focus for immunotherapy efficacy evaluation; 4. Patients who sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with previous acute cardiogenic disease or chronic basic disease may interfere with the treatment after assessment, such as uncontrolled hypertension, unstable angina or myocardial infarction within 6 months before the trial group, or poorly controlled arrhythmia (including QTc interval >= 450 ms for men, 470 MS for women, and calculated by friderica formula), etc; 2. Patients with serious liver and kidney function damage in the past; 3. Patients who can't tolerate PD-1 treatment in the end stage; Four Patients with autoimmune diseases: Patients with symptomatic autoimmune diseases (such as the following, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [hypothyroidism caused by radiotherapy can be included]; patients with vitiligo or asthma in childhood have been completely relieved In adults, asthma can be included without any intervention, while asthma in subjects requiring medical intervention with bronchodilator can not be included; 5. Subjects who need to receive systemic corticosteroids (doses equivalent to or higher than 10 mg / day prednisone) or other immunosuppressive drugs within 14 days before enrollment or during the study period; 6. Patients who have previously been exposed to any anti-PD-1 monoclonal antibody or anti-PD-L1 monoclonal antibody: patients who have ever been treated with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody or anti lymphocyte antigen 4 (CTLA-4) antibody (including apilimumab or any other antibody or drug specifically acting on T-cell co stimulation or checkpoint pathway); 7. Patients with previous history of other tumors, except for cervical cancer in situ, treated squamous cell carcinoma or bladder epithelial tumor (TA and TIS) or other malignant tumors that have received radical treatment (at least 5 years before enrollment); 8. Patients with active tuberculosis infection found by history or CT examination, or patients with active tuberculosis infection history within one year before enrollment, or patients with active tuberculosis infection history more than one year ago but without regular treatment; 9. Patients who have been known to be allergic to macromolecular protein preparations / monoclonal antibodies, or to any test drug components; 10. Patients with HBsAg positive and HBV DNA > 10^3copies/ mL, or hepatitis C virus antibody positive, syphilis positive; 11. Patients with a history of human immunodeficiency virus infection, or other acquired or congenital immunodeficiency diseases, or organ transplantation; 12. The subjects had active infection or had fever of unknown cause during the screening period and before the first administration > 38.5 degrees C (according to the judgment of the researchers, the fever of the subjects due to tumor can be included in the group); 13. Patients with a history of alcohol, drug or drug abuse in the past year; 14. Patients with a clear history of neurological or mental disorders, such as epilepsy, dementia, and poor compliance; 15. Subjects who, in the opinion of the researchers, were not suitable for the trial for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival, PFS; | — |
Countries
China
Contacts
Public ContactBai Chong
Shanghai Changhai Hospital
Outcome results
None listed