[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540184":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":30,"locations":36,"responsibleParty":56,"collaborators":11,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":11,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":11,"enrollmentInfo":68,"targetDuration":11,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":11,"overallStatus":39,"whyStopped":11,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Fudan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PD-1\u002FPD-L1 inhibitor combined with chemotherapy","ACTIVE_COMPARATOR",null,[13],"Drug: PD-1\u002FPD-L1 inhibitor combined with platinum-based chemotherapy",{"label":15,"type":16,"description":11,"interventionNames":17},"Treatment response adapted hybrid radiotherapy plus PD-1\u002FPD-L1 inhibitor and chemotherapy","EXPERIMENTAL",[18,13],"Radiation: SBRT or LDRT",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"RADIATION","SBRT or LDRT","Radiotherapy: (1) Low dose radiotherapy (LDRT) : a dose of 2 Gy\u002F1 Fx was given to all visible lesions in the whole body within 1 week before the first course of PD-1\u002FPD-L1 inhibitor combined with chemotherapy (different parts of the lesion could be irradiated separately, but it was required to be completed within 1 week); (2) SBRT: patients received first-line immunotherapy combined with chemotherapy, and their response was evaluated every 6 weeks. Individualized SBRT was planned based on the treatment responses.",[15],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":11},"DRUG","PD-1\u002FPD-L1 inhibitor combined with platinum-based chemotherapy","The control group received standard PD-1\u002FPD-L1 inhibitor combined with platinum-based chemotherapy as first-line treatment, and the experimental group received extra treatment response adapted hybrid radiotherapy.",[9,15],[31],{"name":32,"role":33,"phone":34,"phoneExt":11,"email":35},"Zhengfei Zhu","CONTACT","+86-18017312901","fuscczzf@163.com",[37],{"facility":38,"status":39,"city":40,"state":11,"zip":11,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Fudan University Shanghai Cancer Center","RECRUITING","Shanghai","China","CN",{"type":44,"coordinates":45},"Point",[46,47],121.45806,31.22222,{"lat":47,"lon":46},[50,52],{"name":51,"role":33,"phone":34,"phoneExt":11,"email":35},"Zhengfei Zhu, MD",{"name":53,"role":33,"phone":54,"phoneExt":11,"email":55},"Jianjiao Ni, MD","13761974092","nijianjiao8@sina.com",{"type":57,"investigatorFullName":32,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Professor","100540184","phase-2-treatment-response-adapted-hybrid-radiotherapy-in-metastatic-non-small-cell-lung-cancer-receiving-first-line-immunotherapy-100540184",false,"NCT06313541","Treatment Response Adapted Hybrid Radiotherapy in Metastatic Non-small Cell Lung Cancer Receiving First-line Immunotherapy","A Multicenter, Randomized Controlled Clinical Trial of Treatment Response Adapted Hybrid Radiotherapy in Metastatic Non-small Cell Lung Cancer Receiving First-line Immunotherapy","Inclusion Criteria:\n\n* ECOG functional status score was 0-1.\n* Histologically confirmed stage IV primary NSCLC;\n* Genetic testing showed that the common driver genes including EGFR, ALK and ROS-1 were negative;\n* Patients with brain metastases were eligible if they were neurologically asymptomatic and had stable disease without receiving systemic glucocorticoids;\n* According to the investigator's judgment, the patient does not need to receive palliative radiotherapy for any site at present;\n* Male\u002Ffemale of childbearing age agreed to use contraception (surgical ligation or oral contraceptive\u002Fintrauterine device plus condom) during the trial;\n* Life expectancy ≥3 months;\n* One week before enrollment, the organ function level met the following criteria:\n\n  ① Bone marrow function: hemoglobin ≥80g\u002FL, white blood cell count ≥4.0\\*10\\^9\u002FL or neutrophil count ≥1.5\\*10\\^9\u002FL, platelet count ≥100\\*10\\^9\u002FL;\n\n  ② Liver: serum total bilirubin level ≤1.5 times upper limit of normal, direct bilirubin level must be ≤1.5 times upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times upper limit of normal;\n\n  ③ Kidney: serum creatinine \\\u003C 1.5 times upper limit of normal or creatinine clearance ≥50ml\u002Fmin, urea nitrogen ≤200mg\u002FL; Serum albumin ≥30g\u002FL;\n* Patients must be able to understand and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* The patient had severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granulomatosis), etc.\n* Symptomatic interstitial lung disease or active infectious\u002Fnon-infectious pneumonia;\n* Patients with risk factors for intestinal perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer, or other known risk factors for intestinal perforation;\n* History of other malignant tumors;\n* Patients with active infection, heart failure, myocardial infarction, unstable angina or unstable arrhythmia within the past 6 months;\n* Medical examination or clinical findings, or other uncontrollable conditions that the investigator considers may interfere with the results or increase the patient's risk of treatment complications;\n* Patients who were considered by the investigator to have lesions requiring palliative and subtractive radiotherapy;\n* Mixed with small cell lung cancer components;\n* Lactating or pregnant women;\n* Congenital or acquired immunodeficiency diseases including human immunodeficiency virus (HIV), organ transplantation or allogeneic stem cell transplantation;\n* Known HBV, HCV, active pulmonary tuberculosis infection;\n* Patients had received a cancer vaccine or received another vaccine within 4 weeks before starting treatment (note: injectable seasonal influenza vaccine is usually inactivated, so vaccination is allowed, while intranasal vaccine is usually live attenuated, so it is not allowed);\n* Patients with concurrent use of other immune agents, chemotherapy drugs, drugs in other clinical studies, and long-term use of cortisol were excluded.\n* Patients with mental disorders, substance abuse, or social problems that affect adherence were excluded from the study after physician review;\n* Patients who are allergic to or contraindicated to PD-1 monoclonal antibody or chemotherapy drugs.","ALL","18 Years",{"count":69,"type":70},146,"ESTIMATED","INTERVENTIONAL",[73],"PHASE2","This study is a multicenter, randomized controlled clinical trial to explore the preliminary efficacy and safety of treatment response adapted hybrid radiotherapy (LDRT and SBRT) in the first-line treatment of immunotherapy combined with chemotherapy for advanced driver-gene negative NSCLC, and to provide new ideas for the comprehensive treatment of advanced NSCLC",[76],"NSCLC Stage IV","2024-06-04",{"date":79,"type":80},"2024-06-05","ACTUAL",{"date":82,"type":80},"2024-04-10",{"date":84,"type":70},"2025-12-31",{"name":5,"class":6},1]