Non-small cell lung cancer
Conditions
Interventions
Experimental group:Camrelizumab + chemotherapy +SBRT+LDRT
Sponsors
Shandong Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age =18 years old, male or female; 2. The Eastern Cancer Collaboration Group (ECOG) had a physical status score of 0 or 1; 3. Life expectancy of more than 3 months; 4. Histological or cytological diagnosis of inoperable stage IV non-small cell lung cancer (as determined by the International Association for the Study of Lung Cancer Manual on Thoracic Tumor Staging, 9th Edition); 5. There is at least one measurable lesion (according to the RECIST 1.1 standard, the CT scan diameter of tumor lesion is =10mm, and the CT scan diameter of lymph node lesion is =15mm), and the lesion that has received radiotherapy before cannot be considered as the target lesion unless there is definite progression after radiotherapy. 6. Had not received systemic anti-tumor therapy before enrollment; Chemotherapy and/or radiotherapy are permitted as part of neoadjuvant/adjuvant therapy, as long as treatment has ended at least 6 months before the diagnosis of advanced or metastatic disease. Palliative radiotherapy (including craniobrain radiotherapy for symptomatic BMS and bone metastases) was permitted, provided that radiotherapy was completed at least 1 week prior to admission and that radiation-related toxicity returned to grade 1 or less (CTCAE 5.0, except for alopecia); 7. Have at least 2 lesions suitable for SBRT and LDRT; 8. PD-L1 expression was negative (TPS<1%); 9. Good function of major organs: 1) Good hematopoietic function, defined as absolute neutrophil count =1.5×109/L, platelet count =100×109/L, hemoglobin =90g/L[no blood transfusion or no erythropoietin (EPO) dependence within 7 days]; 2) Patients with good liver function and no liver metastasis, defined as total bilirubin level =1.5 times the upper limit of normal (ULN); Glutamic oxalic aminotransferase (AST) and glutamic pyruvic aminotransferase (ALT) levels =2.5 times ULN, alkaline phosphatase =2.5 times ULN, and AST and ALT levels =5 times ULN for patients with recorded liver metastasis; 3) Good renal function, defined as serum creatinine =1.5 times ULN or calculated creatinine clearance = 60ml/min (Cockcroft-Gault formula); Urine protein is less than 2+ for routine urine examination. If the patient has urine protein =2+ at baseline level, 24-hour urine should be collected and 24-hour urine protein quantitative detection =1g should be demonstrated. 4) Good coagulation function, defined as International standardized ratio (INR) or prothrombin time (PT) =1.5 times ULN; 10. Willing and able to comply with study plan visits, treatment plans, laboratory tests and other study procedures; 11. For fertile female subjects, a serum pregnancy test should be performed within 7 days prior to the first study intervention (study drug, radiation therapy) and the result should be negative. Participants must agree to use highly effective contraception (i.e., a method with a failure rate of less than 1% per year) for at least 180 days after stopping the trial treatment.
Exclusion criteria
Exclusion criteria: 1. Histologically confirmed small cell lung cancer components; 2. There is sensitive EGFR mutation or ALK rearrangement /ROS1 fusion; 3. Subjects who are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose, or who have received or plan to receive live vaccine within =4 weeks prior to the first dose; 4. Confirm symptomatic, untreated, or positively progressive central nervous system (CNS) metastases by CT or MRI evaluation during screening and prior to radiographic evaluation. However, asymptomatic patients with stable CNS lesions who have been treated can also be enrolled if all of the following conditions are met: 1) Less than 5 brain metastases; 2) Measurable lesions as determined by RECIST v1.1 must be present outside the CNS; 3) The patient had no history of intracranial or spinal hemorrhage; 4) No neurosurgical resection was performed within 28 days prior to initiation of study therapy; 5) Imaging before enrollment confirmed that it had been stable for at least 4 weeks, and systemic sex hormone therapy (dose =10mg/ day prednisone or other equivalent hormone) had been stopped for more than 2 weeks; 6) No metastasis to the midbrain, pons, medulla, or spinal cord; 5. Have an active, known, or suspected autoimmune disease, or a history of autoimmune disease, except for vitiligo, alopecia, Grave's disease, psoriasis, or eczema that has not required systemic treatment within the last 2 years, Hypothyroidism (caused by autoimmune thyroiditis) that is asymptomatic or requires only a steady dose of hormone replacement therapy, and type 1 diabetes that requires only a steady dose of insulin replacement therapy, or childhood asthma that has been in complete remission without any intervention as an adult, or the disease does not recur in the absence of external triggers; 6. Subjects with interstitial pneumonia, drug-induced pneumonia, radiation pneumonia requiring steroid treatment or active pneumonia with clinical symptoms or a history of active pulmonary tuberculosis infection; 7. Known allergy to drugs or excipients, known severe allergic reaction to any monoclonal antibody; 8. Other malignant tumors developed within 5 years or less before the first administration, except adequately treatable cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery; 9. Subjects with known mental illness, alcoholism, inability to quit smoking, drug abuse or drug abuse, suffering from grade II or above myocardial ischemia or myocardial infarction, and poorly controlled arrhythmias (including QTc interval =450 ms for men and =470 ms for women); 10. According to NYHA standard ? ~ ? cardiac insufficiency or heart color ultrasonography: LVEF (left ventricular ejection fraction) < 50% subjects; 11. HBsAg positive and HBV DNA test value exceeding the upper limit of normal (1000 copy number /mL or 500 IU/mL), or HCV positive (HCV RNA or HCV Ab test indicates acute or chronic infection), or a known history of HIV positive or known AIDS; 12. In the investigator's judgment, the subjects have other factors that may lead to the forced termination of the study, such as non-adherence to the protocol, other serious illnesses (including mental illness) requiring combined treatment, serious laboratory abnormalities, family or social factors that may affect the safety of the subjects, or the collection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactZhe Yang
Shandong Provincial Hospital
Outcome results
None listed