[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05118789":3,"trial-entities:NCT05118789":778,"trial-summary:NCT05118789":784},{"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":22,"primary_purpose":23,"phases":24,"enrollment_info":27,"interventions":30,"primary_outcomes":42,"secondary_outcomes":55,"sex":123,"minimum_age":124,"maximum_age":125,"healthy_volunteers":126,"eligibility_criteria":127,"std_ages":131,"locations":135,"central_contacts":766,"overall_officials":772,"references":776,"see_also_links":777},"NCT05118789","NVL-520-01","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)","RECRUITING","2028-12-31","2025-07","2025-10-24","2022-01-04","Nuvalent Inc.","INDUSTRY",true,"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.","In Phase 2, study patients will be enrolled into 5 distinct expansion cohorts:\n\n* Cohort 2a: ROS1-positive NSCLC naïve to Tyrosine Kinase Inhibitor (TKI) therapy and up to 1 prior chemotherapy and\u002For immunotherapy.\n* Cohort 2b: ROS1-positive NSCLC treated with 1 prior ROS1 TKI and no prior chemotherapy or immunotherapy.\n* Cohort 2c: ROS1-positive NSCLC treated with 1 prior ROS1 TKI and 1 prior platinum-based chemotherapy with or without immunotherapy.\n* Cohort 2d: ROS1-positive NSCLC treated with ≥2 prior ROS1 TKIs and up to 1 prior chemotherapy and\u002For immunotherapy.\n* Cohort 2e: ROS1-positive solid tumor and progressed on any prior therapy.",[19,20],"Locally Advanced Solid Tumor","Metastatic Solid Tumor",[],"INTERVENTIONAL","TREATMENT",[25,26],"PHASE1","PHASE2",{"count":28,"type":29},359,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","Zidesamtinib (NVL-520)","Oral tablet of zidesamtinib (NVL-520)",[36,37,38,39,40,41],"Cohort 2a","Cohort 2b","Cohort 2c","Cohort 2d","Cohort 2e","Phase 1 dose escalation",[43,47,51],{"measure":44,"description":45,"timeFrame":46},"Maximum Tolerated Dose (MTD) (Phase 1)","Highest dose with dose-limiting toxicity (DLT) rate ≤ 25%","Within 28 days of last patient dosed during dose escalation",{"measure":48,"description":49,"timeFrame":50},"Recommended Phase 2 Dose (RP2D)","To determine the RP2D","Within 28 days of last patient dosed during dose escalation.",{"measure":52,"description":53,"timeFrame":54},"Objective Response Rate (ORR) (Phase 2)","To determine ORR as assessed by BICR","2-3 years after first patient dosed.",[56,60,64,67,70,73,76,79,82,85,88,91,95,98,101,104,108,111,114,117,120],{"measure":57,"description":58,"timeFrame":59},"Number of participants with treatment-emergent adverse events, as assessed by CTCAE, v5.0","Incidence and severity of treatment-emergent adverse events (TEAEs)","Approximately 3 years.",{"measure":61,"description":62,"timeFrame":63},"Maximum plasma concentration (Cmax) of NVL-520","To determine the maximum plasma concentration (Cmax) of NVL-520","Pre-dose and up to 24 hours post-dose",{"measure":65,"description":66,"timeFrame":63},"Plasma concentration at the end of the dosing interval (Ctau) of NVL-520","To determine the plasma concentration at the end of the dosing interval (Ctau) of NVL-520",{"measure":68,"description":69,"timeFrame":63},"Average plasma concentration (Cavg) of NVL-520","To determine the average plasma concentration (Cavg) of NVL-520",{"measure":71,"description":72,"timeFrame":63},"Time of maximum concentration (Tmax) of NVL-520","To determine the time of maximum concentration (Tmax) of NVL-520",{"measure":74,"description":75,"timeFrame":63},"Area under the curve at the end of the dosing interval (AUCtau) of NVL-520","To determine the area under the curve at the end of the dosing interval (AUCtau) of NVL-520",{"measure":77,"description":78,"timeFrame":63},"Area under the curve from time 0 to 24 (AUC0-24) of NVL-520","To determine the area under the curve from time 0 to 24 (AUC0-24) of NVL-520",{"measure":80,"description":81,"timeFrame":63},"Area under the curve from time 0 to infinity (AUCinf) of NVL-520","To determine the area under the curve from time 0 to infinity (AUCinf) of NVL-520",{"measure":83,"description":84,"timeFrame":63},"Oral clearance (CL\u002FF) of NVL-520","To determine the oral clearance (CL\u002FF) of NVL-520",{"measure":86,"description":87,"timeFrame":63},"Volume of distribution (Vz\u002FF) of NVL-520","To determine the volume of distribution (Vz\u002FF) of NVL-520",{"measure":89,"description":90,"timeFrame":63},"Half-life (t1\u002F2) of NVL-520","To determine the half-life (t1\u002F2) of NVL-520",{"measure":92,"description":93,"timeFrame":94},"Objective response rate (ORR)","Determine ORR as assessed by BICR","2-3 years after first patient dosed",{"measure":96,"description":97,"timeFrame":94},"Duration of response (DOR)","Determine DOR of NVL-520 until radiographic disease progression or death",{"measure":99,"description":100,"timeFrame":94},"Clinical benefit rate (CBR)","Determine CBR of NVL-520",{"measure":102,"description":103,"timeFrame":94},"Time to response","Determine time to response of NVL-520",{"measure":105,"description":106,"timeFrame":107},"Progression-free survival (PFS)","Determine PFS of NVL-520 until radiographic disease progression or death","Approximately 3 years",{"measure":109,"description":110,"timeFrame":107},"Overall survival (OS)","Determine OS",{"measure":112,"description":113,"timeFrame":107},"Rate of CNS progression","The incidence of CNS as first site of progression, alone or with concurrent extra-CNS progression",{"measure":115,"description":116,"timeFrame":107},"Intracranial objective response rate (IC-ORR)","Determine the intracranial objective response rate",{"measure":118,"description":119,"timeFrame":94},"Quality of life assessment using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)","EORTC QLQ-C30 measures cancer patients' physical, psychological, and social functions. Scale ranges from: 1, \"Not at all\"; 2, \"A little\"; 3, \"Quite a bit\"; to 4, \"Very much.\" Higher score for the functioning scales and global health status denotes a better level of functioning, while higher scores on the symptom and single-item scales indicate a higher level of symptoms.",{"measure":121,"description":122,"timeFrame":94},"Quality of life assessment using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 29 module (EORTC QLQ-LC29)","EORTC-QLQ-LC29 measures the quality of life in patients with lung cancer. Symptom scale ranges from: 1, \"Not at all\"; 2, \"A little\"; 3, \"Quite a bit\"; to 4, \"Very much.\" For symptoms scales, higher scores indicated greater symptom burden.","ALL","12 Years",null,false,{"inclusion":128,"exclusion":129,"raw_text":130},[],[],"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.",[132,133,134],"CHILD","ADULT","OLDER_ADULT",[136,149,159,169,180,191,202,213,224,231,242,253,263,270,281,292,303,314,323,334,345,357,368,378,390,401,412,422,432,442,452,463,473,483,492,502,512,522,533,543,553,563,573,580,590,601,610,620,627,638,648,655,662,673,683,690,700,707,714,725,735,745,756],{"facility":137,"status":8,"city":138,"state":139,"zip":140,"country":141,"contacts":142,"geoPoint":146},"UCI Medical Center","Orange","California","92868","United States",[143],{"name":144,"role":145},"Misako Nagasaka, MD, PhD","PRINCIPAL_INVESTIGATOR",{"lat":147,"lon":148},33.78779,-117.85311,{"facility":150,"status":8,"city":151,"state":139,"zip":152,"country":141,"contacts":153,"geoPoint":156},"Stanford Medicine","Palo Alto","94305",[154],{"name":155,"role":145},"Joel Neal, MD, PhD",{"lat":157,"lon":158},37.44188,-122.14302,{"facility":160,"status":8,"city":161,"state":139,"zip":162,"country":141,"contacts":163,"geoPoint":166},"UC Davis Comprehensive Cancer Center","Sacramento","95817",[164],{"name":165,"role":145},"Jonathan Riess, MD",{"lat":167,"lon":168},38.58157,-121.4944,{"facility":170,"status":8,"city":171,"state":172,"zip":173,"country":141,"contacts":174,"geoPoint":177},"University of Colorado Cancer Center","Denver","Colorado","80045",[175],{"name":176,"role":145},"Ross Camidge, MD",{"lat":178,"lon":179},39.73915,-104.9847,{"facility":181,"status":8,"city":182,"state":183,"zip":184,"country":141,"contacts":185,"geoPoint":188},"Georgetown University Medical Center","Washington D.C.","District of Columbia","20007",[186],{"name":187,"role":145},"Stephen Liu, MD",{"lat":189,"lon":190},38.89511,-77.03637,{"facility":192,"status":8,"city":193,"state":194,"zip":195,"country":141,"contacts":196,"geoPoint":199},"University of Miami","Coral Gables","Florida","33146",[197],{"name":198,"role":145},"Gilberto de Lima Lopes, MD",{"lat":200,"lon":201},25.72149,-80.26838,{"facility":203,"status":8,"city":204,"state":205,"zip":206,"country":141,"contacts":207,"geoPoint":210},"University of Chicago","Chicago","Illinois","60637",[208],{"name":209,"role":145},"Marina Garassino, MD",{"lat":211,"lon":212},41.85003,-87.65005,{"facility":214,"status":8,"city":215,"state":216,"zip":217,"country":141,"contacts":218,"geoPoint":221},"Mass General Hospital","Boston","Massachusetts","02114",[219],{"name":220,"role":145},"Jessica Lin, MD",{"lat":222,"lon":223},42.35843,-71.05977,{"facility":225,"status":8,"city":215,"state":216,"zip":226,"country":141,"contacts":227,"geoPoint":230},"Dana-Farber Cancer Institute","02215",[228],{"name":229,"role":145},"Alice Shaw, MD, PhD",{"lat":222,"lon":223},{"facility":232,"status":8,"city":233,"state":234,"zip":235,"country":141,"contacts":236,"geoPoint":239},"Henry Ford Cancer Institute","Detroit","Michigan","48202",[237],{"name":238,"role":145},"Shirish Gadgeel, MD",{"lat":240,"lon":241},42.33143,-83.04575,{"facility":243,"status":8,"city":244,"state":245,"zip":246,"country":141,"contacts":247,"geoPoint":250},"Washington University School of Medicine","St Louis","Missouri","63110",[248],{"name":249,"role":145},"Saiama Waqar, MD",{"lat":251,"lon":252},38.62727,-90.19789,{"facility":254,"status":8,"city":255,"state":255,"zip":256,"country":141,"contacts":257,"geoPoint":260},"NYU Langone Health","New York","10016",[258],{"name":259,"role":145},"Elaine Shum, MD",{"lat":261,"lon":262},40.71427,-74.00597,{"facility":264,"status":8,"city":255,"state":255,"zip":265,"country":141,"contacts":266,"geoPoint":269},"Memorial Sloan Kettering Cancer Center","10065",[267],{"name":268,"role":145},"Alexander Drilon, MD",{"lat":261,"lon":262},{"facility":271,"status":8,"city":272,"state":273,"zip":274,"country":141,"contacts":275,"geoPoint":278},"Atrium Health Levine Cancer Institute","Charlotte","North Carolina","28204",[276],{"name":277,"role":145},"Daniel Haggstrom, MD",{"lat":279,"lon":280},35.22709,-80.84313,{"facility":282,"status":8,"city":283,"state":284,"zip":285,"country":141,"contacts":286,"geoPoint":289},"Ohio State University","Columbus","Ohio","43210",[287],{"name":288,"role":145},"Dwight Owen, MD, MS",{"lat":290,"lon":291},39.96118,-82.99879,{"facility":293,"status":8,"city":294,"state":295,"zip":296,"country":141,"contacts":297,"geoPoint":300},"Fox Chase Cancer Center","Philadelphia","Pennsylvania","19111",[298],{"name":299,"role":145},"Jessica Bauman, MD",{"lat":301,"lon":302},39.95238,-75.16362,{"facility":304,"status":8,"city":305,"state":306,"zip":307,"country":141,"contacts":308,"geoPoint":311},"Sarah Cannon Research Institute","Nashville","Tennessee","37203",[309],{"name":310,"role":145},"Melissa Johnson, MD",{"lat":312,"lon":313},36.16589,-86.78444,{"facility":315,"status":316,"city":317,"state":318,"zip":319,"country":141,"geoPoint":320},"MD Anderson Cancer Center","ACTIVE_NOT_RECRUITING","Houston","Texas","77030",{"lat":321,"lon":322},29.76328,-95.36327,{"facility":324,"status":8,"city":325,"state":326,"zip":327,"country":141,"contacts":328,"geoPoint":331},"NEXT Oncology - Virginia Cancer Specialists","Fairfax","Virginia","22031",[329],{"name":330,"role":145},"Alexander Spira, MD, PhD",{"lat":332,"lon":333},38.84622,-77.30637,{"facility":335,"status":8,"city":336,"state":337,"zip":338,"country":141,"contacts":339,"geoPoint":342},"University of Washington \u002F Fred Hutchinson Cancer Center","Seattle","Washington","98109",[340],{"name":341,"role":145},"Christina Baik, MD, MPH",{"lat":343,"lon":344},47.60621,-122.33207,{"facility":346,"status":8,"city":347,"state":348,"zip":349,"country":350,"contacts":351,"geoPoint":354},"Chris O'Brien Lifehouse","Camperdown","New South Wales","2050","Australia",[352],{"name":353,"role":145},"Steven Kao, PhD",{"lat":355,"lon":356},-33.88965,151.17642,{"facility":358,"status":8,"city":359,"state":360,"zip":361,"country":350,"contacts":362,"geoPoint":365},"Peter MacCallum Cancer Centre","Melbourne","Victoria","3000",[363],{"name":364,"role":145},"Ben Solomon, MD, PhD",{"lat":366,"lon":367},-37.814,144.96332,{"facility":369,"status":8,"city":370,"zip":361,"country":371,"contacts":372,"geoPoint":375},"University Hospital Leuven","Leuven","Belgium",[373],{"name":374,"role":145},"Christophe Dooms, MD, PhD",{"lat":376,"lon":377},50.87959,4.70093,{"facility":379,"status":8,"city":380,"state":381,"zip":382,"country":383,"contacts":384,"geoPoint":387},"Cross Cancer Institute","Edmonton","Alberta","T6G 1Z2","Canada",[385],{"name":386,"role":145},"Quincy Chu, MD",{"lat":388,"lon":389},53.55014,-113.46871,{"facility":391,"status":8,"city":392,"state":393,"zip":394,"country":383,"contacts":395,"geoPoint":398},"Princess Margaret Cancer Research","Toronto","Ontario","M5GG 1L7",[396],{"name":397,"role":145},"Geoffrey Liu, MD",{"lat":399,"lon":400},43.70643,-79.39864,{"facility":402,"status":8,"city":403,"zip":404,"country":405,"contacts":406,"geoPoint":409},"Centre Legon Berard","Lyon","69008","France",[407],{"name":408,"role":145},"Aurelie Swalduz, MD",{"lat":410,"lon":411},45.74906,4.84789,{"facility":413,"status":8,"city":414,"zip":415,"country":405,"contacts":416,"geoPoint":419},"CHU de Nantes","Nantes","44000",[417],{"name":418,"role":145},"Elvire Pons-Tostivint, MD, PhD",{"lat":420,"lon":421},47.21725,-1.55336,{"facility":423,"status":8,"city":424,"zip":425,"country":405,"contacts":426,"geoPoint":429},"Claudius Regaud Institute","Toulouse","31300",[427],{"name":428,"role":145},"Julien Mazieres, MD, PhD",{"lat":430,"lon":431},43.60426,1.44367,{"facility":433,"status":8,"city":434,"zip":435,"country":405,"contacts":436,"geoPoint":439},"Institute Gustave Roussy","Villejuif","94805",[437],{"name":438,"role":145},"Benjamin Besse, MD, PhD",{"lat":440,"lon":441},48.7939,2.35992,{"facility":443,"status":8,"city":444,"country":445,"contacts":446,"geoPoint":449},"Cologne University Hospital","Cologne","Germany",[447],{"name":448,"role":145},"Juergen Wolf, MD",{"lat":450,"lon":451},50.93333,6.95,{"facility":453,"status":8,"city":454,"zip":455,"country":456,"contacts":457,"geoPoint":460},"Università Politecnica Marche","Ancona","60121","Italy",[458],{"name":459,"role":145},"Rossana Berardi, MD",{"lat":461,"lon":462},43.60717,13.5103,{"facility":464,"status":8,"city":465,"zip":466,"country":456,"contacts":467,"geoPoint":470},"IRCCS Istituto Tumori Giovanni Paolo II","Bari","70124",[468],{"name":469,"role":145},"Domenico Galetta, MD, PhD",{"lat":471,"lon":472},41.12066,16.86982,{"facility":474,"status":8,"city":475,"zip":476,"country":456,"contacts":477,"geoPoint":480},"Istituto Europeo di Oncologia","Milan","20141",[478],{"name":479,"role":145},"Gianluca Spitaleri, MD",{"lat":481,"lon":482},45.46427,9.18951,{"facility":484,"status":8,"city":475,"zip":485,"country":456,"contacts":486,"geoPoint":489},"Fondazione IRCCS Istituto Nazionale dei Tumori","20133",[487],{"name":488,"role":145},"Matteo Duca, MD",{"lat":490,"lon":491},42.78235,12.59836,{"facility":493,"status":8,"city":494,"zip":495,"country":456,"contacts":496,"geoPoint":499},"Istituto Oncologico Veneto","Padova","35128",[497],{"name":498,"role":145},"Giulia Pasello, MD, PhD",{"lat":500,"lon":501},44.38225,11.14261,{"facility":503,"status":8,"city":504,"zip":505,"country":456,"contacts":506,"geoPoint":509},"Ospedale Santa Maria delle Croci","Ravenna","48121",[507],{"name":508,"role":145},"Chiara Bennati, MD",{"lat":510,"lon":511},44.41344,12.20121,{"facility":513,"status":8,"city":514,"zip":515,"country":456,"contacts":516,"geoPoint":519},"Istituto Nazionale Tumori Regina Elena","Rome","00128",[517],{"name":518,"role":145},"Lorenza Landi, MD",{"lat":520,"lon":521},41.89193,12.51133,{"facility":523,"status":8,"city":524,"zip":525,"country":526,"contacts":527,"geoPoint":530},"Kanagawa Cancer Center","Kanagawa","241-8515","Japan",[528],{"name":529,"role":145},"Tetsuro Kondo, MD",{"lat":531,"lon":532},37.58333,139.91667,{"facility":534,"status":8,"city":535,"zip":536,"country":526,"contacts":537,"geoPoint":540},"Okayama University Hospital","Okayama","700-8558",[538],{"name":539,"role":145},"Kiichiro Ninomiya, MD, PhD",{"lat":541,"lon":542},34.65,133.93333,{"facility":544,"status":8,"city":545,"zip":546,"country":526,"contacts":547,"geoPoint":550},"Kindai University Hospital","Osaka","577-8502",[548],{"name":549,"role":145},"Hidetoshi Hayashi, MD, PhD",{"lat":551,"lon":552},34.69379,135.50107,{"facility":554,"status":8,"city":555,"zip":556,"country":526,"contacts":557,"geoPoint":560},"Shizuoka Cancer Center","Shizuoka","411-8777",[558],{"name":559,"role":145},"Ryo Ko, MD, PhD",{"lat":561,"lon":562},34.98333,138.38333,{"facility":564,"status":8,"city":565,"zip":566,"country":526,"contacts":567,"geoPoint":570},"National Cancer Center Hospital","Tokyo","104-0045",[568],{"name":569,"role":145},"Tatsuya Yoshida, MD, PhD",{"lat":571,"lon":572},35.6895,139.69171,{"facility":574,"status":8,"city":565,"zip":575,"country":526,"contacts":576,"geoPoint":579},"The Cancer Institute Hospital Of JFCR","135-8550",[577],{"name":578,"role":145},"Ryo Ariyasu, MD",{"lat":571,"lon":572},{"facility":581,"status":8,"city":582,"zip":583,"country":526,"contacts":584,"geoPoint":587},"Wakayama Medical University Hospital","Wakayama","641-8510",[585],{"name":586,"role":145},"Hiroaki Akamatsu, MD, PhD",{"lat":588,"lon":589},34.23333,135.16667,{"facility":591,"status":8,"city":592,"zip":593,"country":594,"contacts":595,"geoPoint":598},"Netherlands Cancer Institute","Amsterdam","1066","Netherlands",[596],{"name":597,"role":145},"Joop de Langen, MD, PhD",{"lat":599,"lon":600},52.37403,4.88969,{"facility":602,"status":8,"city":603,"country":594,"contacts":604,"geoPoint":607},"University Medical Centre Groningen","Groningen",[605],{"name":606,"role":145},"Anthonie van der Wekken, MD, PhD",{"lat":608,"lon":609},53.21917,6.56667,{"facility":611,"status":8,"city":612,"zip":613,"country":612,"contacts":614,"geoPoint":617},"National University Hospital Singapore","Singapore","119074",[615],{"name":616,"role":145},"Ross A Soo, MD",{"lat":618,"lon":619},1.28967,103.85007,{"facility":621,"status":8,"city":612,"zip":622,"country":612,"contacts":623,"geoPoint":626},"National Cancer Centre Singapore","168583",[624],{"name":625,"role":145},"Daniel Tan, PhD",{"lat":618,"lon":619},{"facility":628,"status":8,"city":629,"zip":630,"country":631,"contacts":632,"geoPoint":635},"National Cancer Center","Gyeonggi-do","10408","South Korea",[633],{"name":634,"role":145},"Ji-Youn Han, MD",{"lat":636,"lon":637},37.58944,126.76917,{"facility":639,"status":8,"city":640,"zip":641,"country":631,"contacts":642,"geoPoint":645},"Seoul National University Hospital","Seoul","03080",[643],{"name":644,"role":145},"Dong-Wan Kim, MD, PhD",{"lat":646,"lon":647},37.566,126.9784,{"facility":649,"status":8,"city":640,"zip":650,"country":631,"contacts":651,"geoPoint":654},"Yonsei University Health System","03722",[652],{"name":653,"role":145},"Byoung Chul Cho, MD, PhD",{"lat":646,"lon":647},{"facility":656,"status":8,"city":640,"zip":657,"country":631,"contacts":658,"geoPoint":661},"Samsung Medical Center","06351",[659],{"name":660,"role":145},"Myung-Ju Ahn, MD, PhD",{"lat":646,"lon":647},{"facility":663,"status":8,"city":664,"zip":665,"country":666,"contacts":667,"geoPoint":670},"University Hospital of A Coruña","A Coruña","15006","Spain",[668],{"name":669,"role":145},"Maria Campelo, MD",{"lat":671,"lon":672},43.37135,-8.396,{"facility":674,"status":8,"city":675,"zip":676,"country":666,"contacts":677,"geoPoint":680},"UOMI Cancer Center - Clinica Tres Torres","Barcelona","08017",[678],{"name":679,"role":145},"Santiago Viteri, MD",{"lat":681,"lon":682},41.38879,2.15899,{"facility":684,"status":8,"city":675,"zip":685,"country":666,"contacts":686,"geoPoint":689},"Vall d'Hebron University Hospital","08035",[687],{"name":688,"role":145},"Enriqueta Felip, MD, PhD",{"lat":681,"lon":682},{"facility":691,"status":8,"city":692,"zip":693,"country":666,"contacts":694,"geoPoint":697},"Gregorio Marañón Hospital","Madrid","28007",[695],{"name":696,"role":145},"Antonio Calles, MD",{"lat":698,"lon":699},40.4165,-3.70256,{"facility":701,"status":8,"city":692,"zip":702,"country":666,"contacts":703,"geoPoint":706},"Hospital Universitario 12 de Octubre","28041",[704],{"name":705,"role":145},"Luis Paz-Ares, MD, PhD",{"lat":698,"lon":699},{"facility":708,"status":8,"city":692,"zip":709,"country":666,"contacts":710,"geoPoint":713},"Hospital Universitario HM Sanchinarro","28050",[711],{"name":712,"role":145},"Ramon Yarza, MD, MBI, MSc",{"lat":698,"lon":699},{"facility":715,"status":8,"city":716,"zip":717,"country":718,"contacts":719,"geoPoint":722},"Chung Shan Medical University Hospital","Taichung","40201","Taiwan",[720],{"name":721,"role":145},"Gee Chen Chang, MD, PhD",{"lat":723,"lon":724},24.1469,120.6839,{"facility":726,"status":8,"city":727,"zip":728,"country":718,"contacts":729,"geoPoint":732},"National Cheng Kung University Hospital","Tainan","70403",[730],{"name":731,"role":145},"Chien-Chung Lin, MD, PhD",{"lat":733,"lon":734},22.99083,120.21333,{"facility":736,"status":8,"city":737,"zip":738,"country":718,"contacts":739,"geoPoint":742},"National Taiwan University Hospital","Taipei","10002",[740],{"name":741,"role":145},"Chia-Chi Lin, MD, PhD",{"lat":743,"lon":744},25.05306,121.52639,{"facility":746,"status":8,"city":747,"zip":748,"country":749,"contacts":750,"geoPoint":753},"Royal Marsden Hospital","London","SW3 6JJ","United Kingdom",[751],{"name":752,"role":145},"Sanjay Popat, MBBS, PhD",{"lat":754,"lon":755},51.50853,-0.12574,{"facility":757,"status":8,"city":758,"zip":759,"country":749,"contacts":760,"geoPoint":763},"Christie NHS Foundation Trust","Manchester","M20 4BX",[761],{"name":762,"role":145},"Yvonne Summers, MD",{"lat":764,"lon":765},53.48095,-2.23743,[767],{"name":768,"role":769,"phone":770,"email":771},"Nuvalent","CONTACT","857-357-7000","clinicaltrials@nuvalent.com",[773],{"name":774,"affiliation":13,"role":775},"Vivek Upadhyay, MD, MBI","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":779,"biomarkers":782},[780,781],"Lung Non-Small Cell Carcinoma","Solid Neoplasm",[783],"ROS1 Gene",{"nct_id":4,"found":15,"summary":785,"prompt_version":795},{"design":786,"status":787,"heading":788,"summary":789,"follow_up":790,"word_count":791,"commitments":792,"compensation":793,"drugs_mentioned":794},"This is a Phase 1\u002F2 study, meaning it will first find the right dose and then test its effectiveness. It is designed to enroll approximately 359 participants.","completed","A Study of Zidesamtinib (NVL-520) for ROS1-Positive Cancers","This study is testing a drug called zidesamtinib (NVL-520) in people with advanced solid tumors, including non-small cell lung cancer (NSCLC), that have a specific genetic change called a ROS1 rearrangement. Zidesamtinib is a type of kinase inhibitor. The study aims to find the safest and most effective dose of zidesamtinib and see how well it shrinks tumors. To join, you must have a ROS1 rearrangement in your tumor. The study is looking for about 359 participants aged 12 and older. The study's success will be measured by how many patients experience their tumors shrinking or disappearing (Objective Response Rate). The current status of the study is unclear.","Objective Response Rate will be measured 2-3 years after the first patient is dosed in Phase 2.",108,"Not specified in the trial record.","Not stated in the trial record.",[33],"v2"]