[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643485":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":30,"responsibleParty":48,"collaborators":10,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":10,"enrollmentInfo":62,"targetDuration":65,"studyType":66,"phases":10,"briefSummary":67,"conditions":68,"keywords":10,"overallStatus":71,"whyStopped":10,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Xiangya Hospital of Central South University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Non-small cell lung cancer brain metastases",null,"This cohort comprises adult patients (aged 18 years and older) with histologically or cytologically confirmed (NSCLC who have brain metastases confirmed by contrast-enhanced head MRI. Participants in this cohort are scheduled to receive standard-of-care radiotherapy combined with PD-1\u002FPD-L1 immune checkpoint inhibitors based on real-world clinical treatment plans.\n\nEligible participants must have an ECOG performance status of 0 to 2, an expected survival of at least 3 months, and be either driver-gene negative or have experienced disease progression following prior targeted therapies.\n\nThe cohort strictly excludes patients who have a history of WBRT, SRS for brain metastases, or brain surgery. Additionally, individuals with contraindications to MRI (or intolerance to gadolinium contrast agents), active autoimmune diseases requiring systemic treatment or long-term high-dose immunosuppressants, and pregnant or lactating women are excluded.",[13],"Radiation: Brain radiotherapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"RADIATION","Brain radiotherapy","Participants in this observational study receive standard-of-care radiotherapy for brain metastases combined with PD-1\u002FPD-L1 immune checkpoint inhibitors. The specific radiotherapy parameters (e.g., technique, target volume, and dose) and immunotherapy details (e.g., specific drug type, dosage, and administration schedule) are entirely determined by the treating physicians or multidisciplinary team (MDT) based on current clinical guidelines and real-world practice.\n\nThis study does not assign, alter, or proactively intervene in any treatment plans. What distinguishes the exposure in this study is the specific tracking and categorization of the real-world timing interval and administration sequence between radiotherapy and immunotherapy (e.g., synchronous vs. asynchronous, radiation-first vs. immunotherapy-first), aiming to evaluate how these naturally occurring temporal variations impact clinical outcomes and immune status.",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Rongrong Zhou, MD, PHD","CONTACT","+8613875898127","zhourr@csu.edu.cn",{"name":27,"role":23,"phone":28,"phoneExt":10,"email":29},"Weihua Liao, MD, PHD","+8613973126486","ouwenliao@163.com",[31],{"facility":5,"status":10,"city":32,"state":33,"zip":10,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Changsha","Hunan","China","CN",{"type":37,"coordinates":38},"Point",[39,40],112.97087,28.19874,{"lat":40,"lon":39},[43,44,45],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},{"name":27,"role":23,"phone":28,"phoneExt":10,"email":29},{"name":46,"role":47,"phone":10,"phoneExt":10,"email":10},"Xianjing Chu, MD","SUB_INVESTIGATOR",{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Rongrong Zhou","Department of Oncology","100643485","impact-of-radiotherapy-immunotherapy-timing-in-nsclc-brain-metastases-100643485",false,"NCT07638709","Impact of Radiotherapy-Immunotherapy Timing in NSCLC Brain Metastases","Immune Microenvironment-driven Radiotherapy-immunotherapy Combined With Time-series Strategy for NSCLC Brain Metastases: an Exploratory Study Based on a Clinical Cohort.","(RT-ICI)","Inclusion Criteria:\n\n* Age ≥ 18 years; no gender restriction;\n* Histologically or cytologically confirmed NSCLC, with brain metastases confirmed by contrast-enhanced cranial MRI;\n* Scheduled to receive radiotherapy combined with a PD-1\u002FPD-L1 inhibitor, in accordance with real-world clinical treatment plans;\n* Negative for driver gene mutations, or positive for mutations but with documented failure of prior targeted therapy;\n* ECOG Performance Status score of 0-2, with an estimated life expectancy of ≥ 3 months;\n* Voluntarily signs the informed consent form and agrees to cooperate with blood\u002Fimaging data collection and follow-up procedures.\n\nExclusion Criteria:\n\n* History of whole-brain radiotherapy, stereotactic radiotherapy for brain metastases, or brain surgery;\n* Presence of contraindications to MRI or inability to tolerate gadolinium-based contrast agents (e.g., severe hepatic or renal insufficiency);\n* Presence of active autoimmune disease requiring systemic treatment, or requirement for long-term use of high-dose immunosuppressive agents;\n* Pregnant or lactating women;\n* Other circumstances deemed by the investigator to involve severe complications or render the patient unsuitable for enrollment.","ALL","18 Years",{"count":63,"type":64},150,"ESTIMATED","2 Years","OBSERVATIONAL","The goal of this observational study is to learn about the effects of the timing of radiation therapy and immunotherapy in adults with non-small cell lung cancer (NSCLC) that has spread to the brain. The main questions it aims to answer are:\n\n1. Does the timing of the two treatments change how long the brain tumor stays stable and how long participants live?\n2. What medical problems do participants have when receiving these treatments at different times?\n3. How does the timing of treatments affect the body's immune system?\n\nResearchers will compare participants who receive radiation and immunotherapy 30 days or less apart to those who receive them more than 30 days apart to see if the timing affects the treatment's success and safety.\n\nParticipants already receiving radiation and immunotherapy as part of their regular medical care will:\n\n1. Allow researchers to collect information about their treatment, health, and medical imaging during regular checkups.\n2. Give a small blood sample during their routine blood draws.\n3. Have standard magnetic resonance imaging (MRI) scans of their brain.",[69,70],"Non Small Cell Lung","Brain Metastasases","NOT_YET_RECRUITING","2026-06-09",{"date":74,"type":75},"2026-06-10","ACTUAL",{"date":77,"type":64},"2026-06-05",{"date":79,"type":64},"2030-06-01",{"name":5,"class":6},1]