[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612199":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":57,"collaborators":59,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":11,"eligibilityCriteria":68,"healthyVolunteers":65,"sex":69,"minAge":70,"maxAge":11,"enrollmentInfo":71,"targetDuration":11,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":11,"overallStatus":41,"whyStopped":11,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"University of California, Davis","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Systemic immune checkpoint inhibitor (ICI)-based therapy informed by PROphet CB and CARG-TT","EXPERIMENTAL",null,[13],"Drug: Systemic (ICI)-based therapy informed by the PROphet CB assay and the CARG-TT assessment.",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care","ACTIVE_COMPARATOR","Standard of care (SOC) biomarker assessment and subsequent selection of SOC systemic therapy.",[19],"Drug: Standard of Care",[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":11},"DRUG","Systemic (ICI)-based therapy informed by the PROphet CB assay and the CARG-TT assessment.","Pretreatment assessment with PROphet CB and CARG-TT, which will be used to determine which first-line systemic treatment participants in the intervention arm receive. Systemic treatment will be pre-determined by the trial, according to the results from PROphet CB and CARG-TT.",[9],{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":11},"Standard of care (SOC) biomarker testing followed by first-line treatment with either anti-PD(L)1 Immune checkpoint inhibitor (ICI) monotherapy or anti-PD(L)1 ICI + chemotherapy.",[15],[30],{"name":31,"affiliation":5,"role":32},"Surbhi Singhal, MD","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":11,"email":37},"CONTACT","(916) 734-3772","susinghal@health.ucdavis.edu",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"University of California Davis Comprehensive Cancer Center","RECRUITING","Sacramento","California","95817","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-121.4944,38.58157,{"lat":51,"lon":50},[54,56],{"name":31,"role":35,"phone":55,"phoneExt":11,"email":37},"916-734-3772",{"name":31,"role":32,"phone":11,"phoneExt":11,"email":11},{"type":58,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[60],{"name":61,"class":62},"National Cancer Institute (NCI)","NIH","100612199","phase-2-risk-adapted-proteomic-guided-systemic-therapy-for-previously-untreated-advanced-non-small-cell-lung-cancer-100612199",false,"NCT07250477","Risk-adapted, Proteomic-guided Systemic Therapy for Previously Untreated Advanced Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Participants must have histologically confirmed non-small cell lung cancer that is metastatic or unresectable (stage IIIC or IV), deemed appropriate to receive standard of care immune checkpoint inhibitor-based therapy given with palliative intent.\n* Age ≥18 years at the time of consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥50%).\n* Ability to understand and willingness to sign the informed consent form (ICF).\n* Stated ability and willingness to adhere to all protocol requirements while on study\n\nExclusion Criteria:\n\n* Tumor with known sensitizing alteration in ALK, EGFR, HER2, MET exon 14, NTRK, RET, or ROS1.\n* Medical comorbidities precluding immune checkpoint inhibitor-based therapy per treating investgator's discretion.\n* Previous systemic therapy for metastatic Stage IIIC or IV NSCLC. Patients who previously completed systemic therapy for early stage or locally advanced NSCLC ≥ 80 days prior to trial registration are eligible for inclusion.\n* Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on study","ALL","18 Years",{"count":72,"type":73},56,"ESTIMATED","INTERVENTIONAL",[76],"PHASE2","This is a phase 2, pragmatic, 1:1 randomized, open-label study that evaluates risk-adapted, proteomic-guided systemic therapy to improve 12-month progression free survival (PFS) among patients with previously untreated advanced non-small cell lung cancer.",[79,80,81,82,83],"Non-small Cell Lung Cancer Stage IIIC","Non-small Cell Lung Cancer Stage IV","Non Small Cell Lung Cancer","Non-small Cell Lung Cancer Metastatic","Non-small Cell Lung Cancer Unresectable","2026-02-04",{"date":86,"type":87},"2026-02-09","ACTUAL",{"date":89,"type":87},"2026-01-30",{"date":91,"type":73},"2036-12",{"name":5,"class":6},1]