advanced Non-small cell lung cancer after first-line/second-line immunotherapy failure
Conditions
Interventions
Test group:SBRT + PD-1/PD-L1 Immune checkpoint therapy + GM-CSF
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Ability to sign informed consent, including compliance with the informed Consent (ICF) and the requirements and restrictions outlined in this protocol; 2.Age ranges from 18 to 85 years old, weight more than 30kg; 3.The scores of physical status (PS) in the Eastern Tumor Cooperative Group (ECOG) were 0, 1 and 2 points; Life expectancy >=3 months; 4.Histopathologically or cytologically confirmed stage IV primary non-small cell lung cancer; 5.Gene detection indicated that the driver genes including EGFR, ALK and ROS1 were negative; 6.Patients progressed after first - or second-line antitumor therapy with no more than 3 lesions progressing. First - or second-line therapy must include Pabolizumab or suglizumab for 6 cycles or more. First - or second-line therapy can include chemotherapy and antiangiogenic therapy; 7.Previously received radiation therapy; 8.The investigators determined that the patient did not need palliative radiotherapy at any site at this time; 9.Patients with brain metastases may be enrolled, but only if they do not require systemic glucocorticoid therapy (more than 10mg of methylprednisolone or equivalent of other hormones) without neurological symptoms and stable lesions; 10.According to RECIST version 1.1, there was at least 1 measurable lesion, and at least 1 chest lesion could receive 10-15Gy/1F dose of SBRT. Lymph nodes can be used as independent measurable lesions and SBRT-receiving lesions. Brain lesions cannot be used as separate SRT lesions, but can be used as evaluable lesions; 11.Patients had adequate hematology and end-organ function at least 1 week prior to enrollment; 12.Men and women of childbearing age agree to use contraception during the trial; 13.Patients receiving anticoagulant therapy: a stable anticoagulant regimen; 14.The human immunodeficiency virus (HIV) test was negative at the time of screening; 15.The hepatitis B surface antigen (HBsAg) test was negative during screening; 16.Hepatitis B surface antibody (HBsAb) test positive at screening, or HBsAb negative at screening, accompanied by either: the hepatitis b virus core antibody (HBcAb) were negative; HBcAb test result is positive, then the hepatitis b virus (HBV) DNA test results were negative (as defined by local laboratory); 17.Hepatitis C virus (HCV) antibody test results are negative at screening, or HCV antibody test results are positive at screening and subsequent HCV RNA test results are negative
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria should be excluded from the study: 1.Mixed with small cell lung cancer 2.More than 3 progressive lesions 3.Combined with other diseases such as cardiovascular, urinary, digestive, hematopoietic, endocrine and metabolic system and other serious complications, liver, kidney insufficiency, psychiatric patients 4.Pregnant or lactating women 5.Patients who do not follow the doctor's advice, cannot judge the efficacy or have insufficient clinical data to judge the efficacy 6.Poor compliance or inability to cooperate by doctor's judgment 7.History of other primary malignancies except for the following: to heal for the purpose of treatment of malignant tumor, and 5 years with no known active disease or higher before treatment, and the potential risk of recurrence is low; proper treatment of non melanoma skin cancer or without evidence of malignant freckles blue ubber-bleb nevus disease; disease free evidence for appropriate treatment of carcinoma in situ 8.Previous treatment with other immunoexperimental drugs 9.Patients who have previously received radiation therapy and/or have lesions that the investigator believes currently require palliative radiation therapy 10.Have serious autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granuloma), etc 11.A history of idiopathic pulmonary fibrosis, systemic pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonia, or idiopathic pneumonia, or evidence of active pneumonia on a chest computed tomography (CT) scan at screening 12.First/second-line therapy with non-pabolizumab or suglizumab immunotherapy, or receiving Pabolizumab or suglizumab for less than 6 cycles 13.Congenital or acquired immunodeficiency diseases include human immunodeficiency virus (HIV), or a history of organ transplantation or allogeneic stem cell transplantation 14.Known hepatitis B virus (HBV), hepatitis C virus (HCV), active tuberculosis infection 15.People who are allergic to or contraindicated against PD-1/PD-L1 drugs and GM-CSF 16.At the same time, other immune agents, chemotherapy drugs, other drugs under clinical study, and long-term cortisoltherapy were used 17.Had received tumor vaccine, or received other vaccines within 4 weeks prior to starting treatment (Note: seasonal influenza vaccines for injection are permitted because they are mostly inactivated, while intranasal preparations are usually live attenuated vaccines.) 18.Researchers believe that infection may result or put patients at increased risk for treatment complications as a result of good physical examination, European clinical trial findings, or other uncontrollable diseases 19.Other conditions in which the investigator considers the subject inappropriate 20.Patients who refuse to sign informed consent after specific explanation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression free survival;Duration of response;Incidence of treatment-related adverse effects; | — |
Countries
China
Contacts
Public ContactXu Yaping
Shanghai Pulmonary Hospital
Outcome results
None listed