Non-small cell lung cancer
Conditions
Interventions
Experimental group:GM-CSF+Tislelizumab Injection
Sponsors
Taizhou Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years; 2. ECOG functional status score of 0-1; 3. Pathological histologically confirmed stage IV primary non-small cell lung cancer; 4. Genetic testing suggestive of driver genes including EGFR, ALK, and ROS-1 are negative; 5. Patients progressing after first-line antitumor therapy, which must include a platinum-containing combination regimen of chemotherapy, but not anti-PD-1/L1, in first-line therapy; 6. Patients with brain metastases may be included, provided they are neurologically symptom-free and have stable lesions without the need for systemic glucocorticoid therapy; 7. Have at least 1 lesion with a diameter of 1 cm-5 cm feasible for SBRT up to a dose of 24 Gy/3Fx and at least 1 evaluable lesion other than those prepared for SBRT (refer to RECIST 1.1); lymph nodes may be included as separate measurable lesions and as receiving SBRT lesions; brain lesions may not be included as separate SBRT lesions or as evaluable evaluable lesions; 8. The patient has not previously undergone radiotherapy; 9. The patient is not currently required to receive palliative decompensated radiotherapy at any site, as determined by the investigator; 10. If the subject has undergone surgery, he or she must have recovered sufficiently from the toxicity and complications of the surgical intervention prior to initiation of treatment; 11. Subjects are required to agree to provide appropriate biopsy tissue specimens prior to and during treatment as required by the clinical trial protocol; 12. Men/women of childbearing potential agree to use contraception (surgical ligation or oral contraceptive pills/intrauterine device + condom contraception) for the duration of the trial; 13. Life expectancy >= 3 months; 14. 1 week prior to enrollment, organ function levels meeting the following criteria; 1) Bone marrow function: hemoglobin >= 80 g/L, white blood cell count >= 4.0x10^9/L or neutrophil count >= 1.5x10^9/L, platelet count >=100x10^9/L; 2) Liver: serum total bilirubin level 1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 50 ml/min, urea nitrogen = 30 g/L. 15. Patients must have the ability to understand and voluntarily sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Prior treatment with an anti-PD-1/L1 immune drug or other immune experimental drugs; 2. The patient has received prior radiation therapy; 3. The patient has a severe autoimmune disease: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (e.g., Wegener's granulomatosis), etc; 4. Symptomatic interstitial lung disease or active infectious/non-infectious pneumonia; 5. Patient with risk factors for bowel perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer or other known risk factors for bowel perforation; 6. History of other malignancies; 7. Patient with active infection, heart failure, previous heart attack within 6 months, unstable angina or unstable arrhythmia; 8. Physical examination or clinical trial findings that, in the opinion of the investigator, may interfere with the results or place the patient at increased risk of treatment complications, or other uncontrollable disease; 9. Patients who, in the opinion of the investigator, have a current lesion requiring palliative decompensated radiotherapy; 10. First-line therapy that does not include a platinum-containing combination chemotherapy regimen; 11. With a mixed small cell lung cancer component; 12. Nursing or pregnant females; 13. Congenital or acquired immunodeficiency disorders including human immunodeficiency virus (HIV), or history of organ transplantation, allogeneic stem cell transplantatioN; 14. Known infection with hepatitis B virus (HBV), hepatitis C virus (HCV), active tuberculosis; 15. Patient has had oncology vaccination or other vaccination within 4 weeks prior to starting treatment (Note: since injectable seasonal influenza vaccines are mostly inactivated vaccines and therefore allowed, intranasal preparations are usually live attenuated vaccines and therefore not allowed); 16. Patients on other immune agents, chemotherapeutic agents, other drugs in clinical studies, and cortisol therapy requiring long-term use were excluded from enrollment; 17. Patients with psychiatric disorders, substance abuse, or social problems that affect compliance will not be enrolled upon physician review; 18. Patients who are allergic to or contraindicated to Tislelizumab Injection or GM-CSF.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Countries
China
Contacts
Public ContactYou Guangxian
Taizhou Cancer Hospital
Outcome results
None listed