Non-small cell lung cancer, NSCLC
Conditions
Interventions
Experimental group:LDRT+SBRT
Control group:Chemotherapy
Sponsors
Hubei Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily joined and signed the written informed consent; 2. Patients aged 18-80 years; 3. Histologically or cytologically confirmed non-small cell lung cancer according to AJCC 8th edition stage IV; 4. No EGFR/ALK/ROS-1 common driver gene mutations; 5. ECOG score 0-2; 6. The expected survival time is not less than 3 months; 7. Patients with stage IV recurrent or metastatic NSCLC who developed secondary drug resistance after previous first-line PD-1/PD-L1 monoclonal antibody combination therapy; 8. Definition of secondary drug resistance: response evaluation CR/PR, drug exposure time at least 2 cycles, no remission duration requirement; Efficacy evaluation SD, drug exposure time and stable disease duration >=6 months; 9. Oligometastatic progression: progression of =1.5×10^9/L, platelet count >=100×10^9/L, hemoglobin >=90g/L 2) Liver function: total bilirubin =50 mL/min (according to Cockcroft and Gault formula) 4) Coagulation function: international normalized ratio (INR) <=1.5 and activated partial thromboplastin time (APTT) <=1.5×ULN.
Exclusion criteria
Exclusion criteria: 1. ongoing participation in other clinical trials; and 2. mutations in common driver genes (EGFR, ALK or ROS1); 3. presence of active infectious disease requiring systemic anti-infective therapy; history of anti-infective therapy or short-course hormone use within 2 weeks, and history of long-term glucocorticoid (used for more than 2 weeks) use within 4 weeks; 4. Patients with a large amount of plasmapheresis, or with plasmapheresis with symptoms, or with poorly controlled plasmapheresis (poorly controlled is defined as a significant increase in plasmapheresis within 2 weeks after puncture and drainage removal); 5. Patients with meningeal metastases or spinal cord compression; 6. first-line immune combination therapy with immune-related adverse reactions greater than or equal to grade 3; 7. History of interstitial lung disease (ILD) requiring hormonal therapy (including pulmonary fibrosis, etc.), or current ILD; 8. imaging studies suggesting that the tumor has invaded or encircled large blood vessels in the abdomen, chest, neck, or pharynx, except in the opinion of the investigator, which does not affect the patient's enrollment in the treatment; 9. have serious comorbidities, including myocardial infarction, severe cardiac arrhythmia, severe cerebrovascular disease, ulcer disease, psychosis and uncontrollable diabetes mellitus; and 10. Hepatitis B surface antigen (HBsAg) positive and HBV-DNA >1000 copies/ml or 200IU/ml; 11. Human immunodeficiency virus antibody (HIV-Ab) positive; 12. Pregnant or breastfeeding females or females/males planning to have children, or subjects who do not agree to use medically approved contraception for contraception during study treatment and for 6 months after the end of the study; 13. Presence of severe psychological or psychiatric abnormalities that interfere with the subject's compliance to participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);Disease control rate (DCR); | — |
Countries
China
Contacts
Public ContactYi Peng; Pingping Zhang
Hubei Cancer Hospital
Outcome results
None listed