Lung cancer
Conditions
Interventions
Control group:Treatment period (1-6 cycles): 1 ml of copper green pseudomonas injection simulant subcutaneous injection on the 1st 3rd 5th 7th 9th day of each cycle.
Test group 2:Treatment Period (1-6 cycles): 1 mL of Pseudomonas aeruginosa injection is injected subcutaneously on days 1 3 and 5 of each cycle and 1 mL of Pseudomonas aeruginosa injection simulator i
Test group 1:Treatment Period (1-6 cycles): 1 ml of Pseudomonas aeruginosa injection subcutaneous injection on days 1 3 5 7 and 9 of each cycle. Maintenance Phase (7 cycles - 2 years): 1 ml of Pseudom
until disease progression or the appearance of unacceptable AEs.
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18-75 (inclusive); 2. Patients with histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with stage IIIB -IV tumors (as determined by the IASLC Manual on Thoracic Tumor Staging 8th Edition); 3. ECOG score is 0-2 points; 4. The expected survival period is greater than 3 months; 5. According to the solid tumor efficacy evaluation criteria (RECIST v1.1 edition) the patient had at least one evaluable target lesion; 6. Hematological indicators and organ function are sufficient to tolerate chemotherapy (excluding the use of any blood components and cell growth factors within 14 days) : White blood cell count =3.0×109/L neutrophil count =1.5×109/L platelet count =80×109/L hemoglobin =8g/dL (80 g/L) total bilirubin = 1.5 times the upper limit of normal ALT AST= 3 times the upper limit of normal (if liver metastasis is present = 5 times the upper limit of normal value) creatinine clearance =45 mL/min (calculated according to the standard Cockcroft-Gault formula); 7. Women of reproductive age or sexually active men should take effective contraceptive measures before enrollment (after signing the ICF and within 3 months after the treatment period and the end of treatment); 8. Able to understand and voluntarily sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed with other histopathological types including NSCLC with small cell lung cancer components; 2. Patients with known EGFR mutation or ALK positive; 3. Previously received immunotherapy including immune checkpoint inhibitors (such as anti-PD-1 /L1 antibody anti-CTLA-4 antibody anti-Tigit antibody anti-LAG-3 antibody etc.) immune checkpoint agonists (such as: Subjects of ICOS CD40 CD137 GITR OX40 antibody etc.) immune cell therapy etc. any treatment targeting the immune mechanism of tumor action; 4. Patients with active central nervous system (CNS) metastasis active autoimmune diseases etc.; 5. Patients with immunodeficiency such as human immunodeficiency virus (HIV) infection poorly controlled infectious diseases such as active hepatitis B or active tuberculosis interstitial pneumonia severe heart liver and kidney diseases coagulopathy mental disorders or concomitant tumours (other than carcinoma in situ or cured thyroid cancer); 6. Serious infections (CTCAE > Grade 2) occurred within 4 weeks prior to enrollment such as infection complications bacteremia severe pneumonia etc. requiring treatment; 7. Major surgery (excluding diagnostic surgery) was performed within 4 weeks prior to enrollment or planned during the study period. 8. People who are alcohol dependent or have a history of drug use or drug abuse within the last 1 year; 9. Pregnant or lactating women; 10. Known allergy to therapeutic drugs or excipients; 11. Received any other investigational drug treatment or participated in another interventional clinical study in the 3 months prior to signing the ICF.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of remission (DOR); Disease control rate (DCR).;Disease control rate (DCR);Proportion of patients with progression-free survival (PFS) and ORR whose tumor volume reduction reached the pre-specified value and maintained the minimum time-frame requirements.;Improvement of immune indexes; | — |
Secondary
| Measure | Time frame |
|---|---|
| Piper fatigue survey scale evaluated the fatigue symptoms of the subjects;;Appetite symptom questionnaire of tumor patients;;OS is defined as the time from randomization to death due to any factor; QLQ-LC4 scale: The Chinese version of the European Organization for Research and Treatment (EORTC) QOL for lung cancer patients QLQ-LC43 was used;; | — |
Countries
China
Contacts
Public Contactzhang yi
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed