[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06943755":3,"trial-entities:NCT06943755":973,"trial-summary:NCT06943755":979},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":30,"interventions":33,"primary_outcomes":46,"secondary_outcomes":50,"sex":68,"minimum_age":69,"maximum_age":17,"healthy_volunteers":70,"eligibility_criteria":71,"std_ages":85,"locations":88,"central_contacts":958,"overall_officials":967,"references":971,"see_also_links":972},"NCT06943755","XL092-311","Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors","A Phase 2\u002F3, Multicenter, Randomized Open-Label Study of Zanzalintinib vs Everolimus in Participants With Previously Treated, Unresectable, Locally Advanced or Metastatic Neuroendocrine Tumors","RECRUITING","2029-06-30","2026-09","2026-09-10","2025-07-21","Exelixis","INDUSTRY",true,"The primary purpose of this study is to assess the effectiveness of zanzalintinib compared to everolimus in participants with previously treated, unresectable, locally advanced or metastatic neuroendocrine tumors.",null,[19,20],"Pancreatic Neuroendocrine Tumor (pNET)","Extra-Pancreatic Neuroendocrine Tumor (epNET)",[22,23,24],"Metastatic Cancer","Locally Advanced Cancer","Neuroendocrine Tumor (NET)","INTERVENTIONAL","TREATMENT",[28,29],"PHASE2","PHASE3",{"count":31,"type":32},440,"ESTIMATED",[34,41],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"DRUG","Zanzalintinib","Administered as specified in the treatment arm.",[36],[40],"XL092",{"type":35,"name":42,"description":37,"armGroupLabels":43,"otherNames":44},"Everolimus",[42],[45],"Afinitor",[47],{"measure":48,"timeFrame":49},"Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)","Up to 48 months",[51,53,55,58,60,62,64,66],{"measure":52,"timeFrame":49},"PFS Per RECIST 1.1 as Assessed by Investigator",{"measure":54,"timeFrame":49},"Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR and Investigator",{"measure":56,"timeFrame":57},"Overall Survival (OS)","Up to 60 months",{"measure":59,"timeFrame":49},"Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR and Investigator",{"measure":61,"timeFrame":49},"Disease Control Rate (DCR) Per RECIST 1.1 as Assessed by BICR and Investigator",{"measure":63,"timeFrame":49},"Change From Baseline in Participant-Reported Global Health Status (GHS) and Disease-Related Symptoms as Assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) Score",{"measure":65,"timeFrame":49},"Change From Baseline in Participant-Reported GHS and Disease-Related Symptoms as Assessed by EORTC Gastrointestinal Neuroendocrine Tumor module (QLQ-GI.NET21) Score",{"measure":67,"timeFrame":49},"Number of Participants With Adverse Events","ALL","18 Years",false,{"inclusion":72,"exclusion":78,"raw_text":84},[73,74,75,76,77],"Histologically confirmed, locally advanced\u002Funresectable or metastatic, well-differentiated Grade 1, 2, or 3 NETs of pancreatic origin or extra-pancreatic origin.","Allowed prior lines of therapy, based on the site of NET and functional status.","Documented radiographic disease progression per RECIST 1.1, as assessed by the Investigator based on imaging assessments (computed tomography \\[CT\\] or magnetic resonance imaging \\[MRI\\]) within 12 months before randomization.","Measurable disease according to RECIST 1.1 as determined by the Investigator.","Archival tumor tissue is required, if available. If archival tumor tissue is not available, a fresh biopsy may be submitted if it can be safely and feasibly obtained. Every attempt should be made to provide tumor tissue.",[79,80,81,82,83],"Histologically confirmed neuroendocrine carcinomas (including small cell lung cancer), medullary thyroid cancer, pheochromocytoma, paraganglioma, Merkel cell carcinoma, and mixed neuroendocrine non-neuroendocrine neoplasm (MiNEN).","Prior treatment with a vascular endothelial growth factor receptor (VEGFR) -targeting tyrosine kinase inhibitor or a mammalian target of rapamycin (mTOR) inhibitor.","Systemic chemotherapy and any liver-directed or other ablative therapy within 4 weeks before randomization.","Systemic radionuclide therapy within 6 weeks before randomization.","Radiation therapy for bone metastases within 2 weeks, any other radiation therapy, except as indicated above, within 4 weeks before randomization.","Key Inclusion Criteria:\n\n* Histologically confirmed, locally advanced\u002Funresectable or metastatic, well-differentiated Grade 1, 2, or 3 NETs of pancreatic origin or extra-pancreatic origin.\n* Allowed prior lines of therapy, based on the site of NET and functional status.\n* Documented radiographic disease progression per RECIST 1.1, as assessed by the Investigator based on imaging assessments (computed tomography \\[CT\\] or magnetic resonance imaging \\[MRI\\]) within 12 months before randomization.\n* Measurable disease according to RECIST 1.1 as determined by the Investigator.\n* Archival tumor tissue is required, if available. If archival tumor tissue is not available, a fresh biopsy may be submitted if it can be safely and feasibly obtained. Every attempt should be made to provide tumor tissue.\n\nKey Exclusion Criteria:\n\n* Histologically confirmed neuroendocrine carcinomas (including small cell lung cancer), medullary thyroid cancer, pheochromocytoma, paraganglioma, Merkel cell carcinoma, and mixed neuroendocrine non-neuroendocrine neoplasm (MiNEN).\n* Prior treatment with a vascular endothelial growth factor receptor (VEGFR) -targeting tyrosine kinase inhibitor or a mammalian target of rapamycin (mTOR) inhibitor.\n* Systemic chemotherapy and any liver-directed or other ablative therapy within 4 weeks before randomization.\n* Systemic radionuclide therapy within 6 weeks before randomization.\n* Radiation therapy for bone metastases within 2 weeks, any other radiation therapy, except as indicated above, within 4 weeks before randomization.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may 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Hillman Cancer Center","Pittsburgh","15232",{"lat":329,"lon":330},40.44062,-79.99589,{"facility":332,"status":8,"city":333,"state":334,"zip":335,"country":94,"geoPoint":336},"University of Tennessee Medical Center","Knoxville","Tennessee","37920",{"lat":337,"lon":338},35.96064,-83.92074,{"facility":340,"status":8,"city":341,"state":334,"zip":342,"country":94,"geoPoint":343},"Henry-Joyce Cancer Clinic","Nashville","37232",{"lat":344,"lon":345},36.16589,-86.78444,{"facility":347,"status":8,"city":348,"state":349,"zip":350,"country":94,"geoPoint":351},"Texas Oncology- Baylor Charles A. Sammons Cancer Center","Dallas","Texas","75264",{"lat":352,"lon":353},32.78306,-96.80667,{"facility":355,"status":8,"city":356,"state":357,"zip":358,"country":94,"geoPoint":359},"Huntsman Cancer Institute, University of Utah","Salt Lake City","Utah","84112",{"lat":360,"lon":361},40.76078,-111.89105,{"facility":363,"status":8,"city":364,"state":365,"zip":366,"country":94,"geoPoint":367},"University of Virginia","Charlottesville","Virginia","22903",{"lat":368,"lon":369},38.02931,-78.47668,{"facility":371,"status":8,"city":372,"state":365,"zip":373,"country":94,"geoPoint":374},"Virginia Cancer Specialists - Fairfax Office","Fairfax","22031",{"lat":375,"lon":376},38.84622,-77.30637,{"facility":378,"status":8,"city":379,"state":380,"zip":381,"country":94,"geoPoint":382},"Fred Hutchinson Cancer Center","Seattle","Washington","98109",{"lat":383,"lon":384},47.60621,-122.33207,{"facility":386,"status":8,"city":387,"state":388,"zip":389,"country":94,"geoPoint":390},"Froedtert Hospital and the Medical College of Wisconsin","Milwaukee","Wisconsin","53226",{"lat":391,"lon":392},43.0389,-87.90647,{"facility":394,"status":8,"city":395,"zip":396,"country":397,"geoPoint":398},"Monash Health","Clayton","3168","Australia",{"lat":399,"lon":400},-37.91667,145.11667,{"facility":402,"status":8,"city":403,"zip":404,"country":397,"geoPoint":405},"Royal Brisbane and Women's Hospital","Herston","4029",{"lat":406,"lon":407},-27.44453,153.01852,{"facility":409,"status":8,"city":410,"zip":411,"country":397,"geoPoint":412},"Peter MacCallum Cancer Centre","Melbourne","3000",{"lat":413,"lon":414},-37.814,144.96332,{"facility":416,"status":8,"city":417,"zip":418,"country":397,"geoPoint":419},"Fiona Stanley Hospital","Murdoch","6150",{"lat":420,"lon":421},-32.06987,115.83757,{"facility":423,"status":8,"city":424,"zip":425,"country":397,"geoPoint":426},"GenesisCare North Shore","St Leonards","2065",{"lat":427,"lon":428},-33.82344,151.19836,{"facility":430,"status":8,"city":431,"zip":432,"country":397,"geoPoint":433},"The Queen Elizabeth Hospital","Woodville South","5011",{"lat":434,"lon":435},-34.88186,138.53477,{"facility":437,"status":8,"city":438,"zip":439,"country":440,"geoPoint":441},"Medical University of Graz","Graz","8036","Austria",{"lat":442,"lon":443},47.06733,15.44197,{"facility":445,"status":8,"city":446,"zip":447,"country":440,"geoPoint":448},"Paracelsus Medical University Hospital Salzburg","Salzburg","5020",{"lat":449,"lon":450},47.79941,13.04399,{"facility":452,"status":8,"city":453,"zip":454,"country":440,"geoPoint":455},"Medical University of Vienna","Vienna","1090",{"lat":456,"lon":457},48.20849,16.37208,{"facility":459,"status":8,"city":460,"zip":461,"country":462,"geoPoint":463},"Institut Jules Bordet","Brussels","1070","Belgium",{"lat":464,"lon":465},50.85045,4.34878,{"facility":467,"status":8,"city":468,"zip":411,"country":462,"geoPoint":469},"UZ Leuven","Leuven",{"lat":470,"lon":471},50.87959,4.70093,{"facility":473,"status":8,"city":474,"zip":475,"country":462,"geoPoint":476},"Cliniques Universitaires Saint-Luc (UCLouvain)","Woluwe-Saint-Lambert","1200",{"lat":477,"lon":478},50.84389,4.42912,{"facility":480,"status":8,"city":481,"zip":482,"country":483,"geoPoint":484},"Associação Hospitalar Moinhos de Vento","Porto Alegre","90560-032","Brazil",{"lat":485,"lon":486},-30.03283,-51.23019,{"facility":488,"status":8,"city":489,"zip":490,"country":491,"geoPoint":492},"Verspeeten Family Cancer Center - 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It plans to enroll 440 participants.","completed","Zanzalintinib Versus Everolimus for Neuroendocrine Tumors","This study is comparing two medicines, zanzalintinib and everolimus, to see which is more effective for people with advanced neuroendocrine tumors that started in the pancreas (pNET) or elsewhere (epNET). These tumors are well-differentiated and have progressed after previous treatments. Zanzalintinib works by blocking certain signals in cancer cells (ERK, KINASE INHIBITOR, MTOR, TYROSINE KINASE, VEGF, VEGFR). You may be able to join if you are 18 or older, have a confirmed diagnosis of these types of neuroendocrine tumors, and your disease has worsened. The main goal is to see how long people live without their cancer growing (Progression-Free Survival) for up to 48 months. The current status of this study is unclear.","The main outcome will be measured for up to 48 months.",113,"Not specified in the trial record.","Not stated in the trial record.",[36,42]]