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MD",{"facility":709,"status":54,"city":710,"state":40,"zip":711,"country":698,"countryCode":699,"cosmosGeoPoint":712,"geoPoint":716,"contacts":717},"UOMI Cancer Center - Clinica Tres Torres","Barcelona","08017",{"type":61,"coordinates":713},[714,715],2.15899,41.38879,{"lat":715,"lon":714},[718],{"name":719,"role":69,"phone":40,"phoneExt":40,"email":40},"Santiago Viteri, MD",{"facility":721,"status":54,"city":710,"state":40,"zip":722,"country":698,"countryCode":699,"cosmosGeoPoint":723,"geoPoint":725,"contacts":726},"Vall d'Hebron University Hospital","08035",{"type":61,"coordinates":724},[714,715],{"lat":715,"lon":714},[727],{"name":728,"role":69,"phone":40,"phoneExt":40,"email":40},"Enriqueta Felip, MD, PhD",{"facility":730,"status":54,"city":731,"state":40,"zip":732,"country":698,"countryCode":699,"cosmosGeoPoint":733,"geoPoint":737,"contacts":738},"Gregorio Marañón Hospital","Madrid","28007",{"type":61,"coordinates":734},[735,736],-3.70256,40.4165,{"lat":736,"lon":735},[739],{"name":740,"role":69,"phone":40,"phoneExt":40,"email":40},"Antonio Calles, MD",{"facility":742,"status":54,"city":731,"state":40,"zip":743,"country":698,"countryCode":699,"cosmosGeoPoint":744,"geoPoint":746,"contacts":747},"Hospital Universitario 12 de Octubre","28041",{"type":61,"coordinates":745},[735,736],{"lat":736,"lon":735},[748],{"name":749,"role":69,"phone":40,"phoneExt":40,"email":40},"Luis Paz-Ares, MD, PhD",{"facility":751,"status":54,"city":731,"state":40,"zip":752,"country":698,"countryCode":699,"cosmosGeoPoint":753,"geoPoint":755,"contacts":756},"Hospital Universitario HM Sanchinarro","28050",{"type":61,"coordinates":754},[735,736],{"lat":736,"lon":735},[757],{"name":758,"role":69,"phone":40,"phoneExt":40,"email":40},"Ramon Yarza, MD, MBI, MSc",{"facility":760,"status":54,"city":761,"state":40,"zip":762,"country":763,"countryCode":764,"cosmosGeoPoint":765,"geoPoint":769,"contacts":770},"Chung Shan Medical University Hospital","Taichung","40201","Taiwan","TW",{"type":61,"coordinates":766},[767,768],120.6839,24.1469,{"lat":768,"lon":767},[771],{"name":772,"role":69,"phone":40,"phoneExt":40,"email":40},"Gee Chen Chang, MD, PhD",{"facility":774,"status":54,"city":775,"state":40,"zip":776,"country":763,"countryCode":764,"cosmosGeoPoint":777,"geoPoint":781,"contacts":782},"National Cheng Kung University Hospital","Tainan","70403",{"type":61,"coordinates":778},[779,780],120.21333,22.99083,{"lat":780,"lon":779},[783],{"name":784,"role":69,"phone":40,"phoneExt":40,"email":40},"Chien-Chung Lin, MD, PhD",{"facility":786,"status":54,"city":787,"state":40,"zip":788,"country":763,"countryCode":764,"cosmosGeoPoint":789,"geoPoint":793,"contacts":794},"National Taiwan University Hospital","Taipei","10002",{"type":61,"coordinates":790},[791,792],121.52639,25.05306,{"lat":792,"lon":791},[795],{"name":796,"role":69,"phone":40,"phoneExt":40,"email":40},"Chia-Chi Lin, MD, PhD",{"facility":798,"status":54,"city":799,"state":40,"zip":800,"country":801,"countryCode":802,"cosmosGeoPoint":803,"geoPoint":807,"contacts":808},"Royal Marsden Hospital","London","SW3 6JJ","United Kingdom","UK",{"type":61,"coordinates":804},[805,806],-0.12574,51.50853,{"lat":806,"lon":805},[809],{"name":810,"role":69,"phone":40,"phoneExt":40,"email":40},"Sanjay Popat, MBBS, PhD",{"facility":812,"status":54,"city":813,"state":40,"zip":814,"country":801,"countryCode":802,"cosmosGeoPoint":815,"geoPoint":819,"contacts":820},"Christie NHS Foundation Trust","Manchester","M20 4BX",{"type":61,"coordinates":816},[817,818],-2.23743,53.48095,{"lat":818,"lon":817},[821],{"name":822,"role":69,"phone":40,"phoneExt":40,"email":40},"Yvonne Summers, MD",{"type":824,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100448387","phase-1-a-study-of-zidesamtinib-nvl-520-in-patients-with-advanced-nsclc-and-other-solid-tumors-harboring-ros1-rearrangement-arros-1-100448387",false,"NCT05118789","A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)","A Phase 1\u002F2 Study of the Highly Selective ROS1 Inhibitor Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors (ARROS-1)","Inclusion Criteria:\n\n1. Age ≥18 years (Cohort 2e only: Age ≥12 years).\n2. Disease Criteria:\n\n   1. Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with documented ROS1 rearrangement.\n   2. Phase 2: Cohorts 2a, 2b, 2c and 2d: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with ROS1 rearrangement.\n   3. Phase 2: Cohort 2e: Histologically or cytologically confirmed locally advanced or metastatic solid tumor (other than NSCLC) with ROS1 rearrangement.\n3. Prior anticancer treatment (except cohort 2a).\n4. Phase 1: Must have evaluable disease (target or nontarget) according to RECIST 1.1. Phase 2: Must have measurable disease according to RECIST 1.1.\n5. Adequate baseline organ function and bone marrow reserve.\n\nExclusion Criteria:\n\n1. Patient's cancer has a known oncogenic driver alteration other than ROS1.\n2. Known allergy\u002Fhypersensitivity to excipients of NVL-520.\n3. Major surgery within 4 weeks of first dose of study drug.\n4. Ongoing anticancer therapy.\n5. Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.","ALL","12 Years",{"count":835,"type":836},359,"ESTIMATED","INTERVENTIONAL",[839,840],"PHASE1","PHASE2","Phase 1\u002F2, dose escalation and expansion study designed to evaluate the safety and tolerability of zidesamtinib (NVL-520), determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ROS1-positive (ROS1+) NSCLC and other advanced ROS1-positive solid tumors.\n\nPhase 1 will determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of zidesamtinib in patients with advanced ROS1-positive solid tumors.\n\nPhase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of zidesamtinib at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of zidesamtinib in patients with advanced ROS1-positive NSCLC and other solid tumors.",[843,844],"Locally Advanced Solid Tumor","Metastatic Solid Tumor","2025-10-22",{"date":847,"type":848},"2025-10-24","ACTUAL",{"date":850,"type":848},"2022-01-04",{"date":852,"type":836},"2028-12-31",{"name":5,"class":6},63]