[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545682":3},{"organization":4,"armGroups":7,"interventions":41,"overallOfficials":68,"centralContacts":72,"locations":79,"responsibleParty":582,"collaborators":77,"id":584,"slug":585,"hasResults":586,"nctId":587,"briefTitle":588,"officialTitle":589,"acronym":590,"eligibilityCriteria":591,"healthyVolunteers":586,"sex":592,"minAge":593,"maxAge":77,"enrollmentInfo":594,"targetDuration":77,"studyType":597,"phases":598,"briefSummary":601,"conditions":602,"keywords":77,"overallStatus":96,"whyStopped":77,"lastUpdateSubmitDate":604,"lastUpdatePostDateStruct":605,"startDateStruct":608,"completionDateStruct":610,"leadSponsor":612,"locationsCount":613},{"fullName":5,"class":6},"Janssen Research & Development, LLC","INDUSTRY",[8,14,19,24,28,32,37],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1: Amivantamab Monotherapy (Dose Expansion)","EXPERIMENTAL","Participants will receive subcutaneous injection of amivantamab monotherapy 1600 milligrams (mg) (2240 mg, if body weight \\>=80 kilograms \\[kg\\]) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight \\>=80 kg) once every week (q1w) for the remainder of Cycle 1 (Days 8 and 15), and every 3 weeks (q3w) from Cycle 2 onwards.",[13],"Biological: Amivantamab",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2: Amivantamab + Pembrolizumab (Dose Expansion Including Safety Run-in)","Participants will receive subcutaneous injection of amivantamab 1600 mg (2240 mg, if body weight \\>=80 kg) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight \\>=80 kg) q1w for the remainder of Cycle 1 (Days 8 and 15), and q3w from Cycle 2 onwards, along with intravenous (IV) injection of pembrolizumab 200 mg q3w (on Day 1 of each 21-day cycle).",[13,18],"Biological: Pembrolizumab",{"label":20,"type":10,"description":21,"interventionNames":22},"Cohort 3A (Dose Confirmation): Amivantamab + Paclitaxel","Participants will receive subcutaneous injection of amivantamab 1600 mg (2240 mg, if body weight \\>=80 kg) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight \\>=80 kg) q1w for the remainder of Cycle 1 (Days 8 and 15), and q3w from Cycle 2 onwards, along with intravenous injection of paclitaxel 175 mg\u002Fm\\^2 q3w (on Day 1 of each 21-day cycle) in dose confirmation Cohort 3A. The recommended Phase 2 combination dose (RP2CD) of amivantamab will be determined in conjunction with study evaluation team (SET) in this dose confirmation Cohort 3A.",[13,23],"Drug: Paclitaxel",{"label":25,"type":10,"description":26,"interventionNames":27},"Cohort 3B (Dose Expansion): Amivantamab + Paclitaxel","Participants will receive subcutaneous injection of amivantamab at the determined RP2CD in addition to intravenous injection of paclitaxel 175 mg\u002Fm\\^2 q3w (on Day 1 of each 21-day cycle) as confirmed by SET in Cohort 3A.",[13,23],{"label":29,"type":10,"description":30,"interventionNames":31},"Cohort 4: Amivantamab Monotherapy","Participants will receive subcutaneous injection of amivantamab monotherapy 1600 mg (2240 mg, if body weight \\>=80 kg) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight \\>=80 kg) q1w for the remainder of Cycle 1 (Days 8 and 15), and q3w from Cycle 2 onwards.",[13],{"label":33,"type":10,"description":34,"interventionNames":35},"Cohort 5: Pembrolizumab + Amivantamab + Carboplatin (Dose Expansion)","Participants will receive subcutaneous injection of amivantamab 1600 mg (2240 mg, if body weight \\>=80 kg) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight \\>=80 kg) q1w for the remainder of Cycle 1 (Days 8 and 15), and q3w from Cycle 2 onwards in addition to intravenous injection of pembrolizumab 200 mg on Day 1 of each cycle, and carboplatin (area under the concentration-time curve \\[AUC\\] 5 milligram per milliliter \\[mg\u002Fml\\]\\*min) q3w on Day 1 of Cycles 1-6.",[13,18,36],"Drug: Carboplatin",{"label":38,"type":10,"description":39,"interventionNames":40},"Cohort 6: Amivantamab + Pembrolizumab","Participants will receive subcutaneous injection of amivantamab 1600 mg (2240 mg, if body weight \\>=80 kg) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight \\>=80 kg) q1w for the remainder of Cycle 1 (Days 8 and 15), and q3w from Cycle 2, along with intravenous injection of pembrolizumab 200 mg q3w (on Day 1 of each 21-day cycle) (Neoadjuvant Phase). In the adjuvant phase, pembrolizumab IV (200 mg) will be administered q3w from Adjuvant Cycle 1 Day 1 to Adjuvant Cycle 15 Day 1 and amivantamab SC 2,400 mg (3,360 mg for \\>80 kg) will be administered q3w from Adjuvant Cycle 4 Day 1 to Adjuvant Cycle 15 Day 1.",[13,18],[42,49,55,62],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"BIOLOGICAL","Amivantamab","Amivantamab will be administered subcutaneously.",[9,15,20,25,29,33,38],[48],"JNJ-61186372",{"type":43,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"Pembrolizumab","Pembrolizumab will be administered intravenously.",[15,33,38],[54],"KEYTRUDA",{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"DRUG","Paclitaxel","Paclitaxel will be administered intravenously.",[20,25],[61],"TAXOL",{"type":56,"name":63,"description":64,"armGroupLabels":65,"otherNames":66},"Carboplatin","Carboplatin will be administered intravenously.",[33],[67],"PARAPLATIN",[69],{"name":70,"affiliation":5,"role":71},"Janssen Research & Development, LLC Clinical Trial","STUDY_DIRECTOR",[73],{"name":74,"role":75,"phone":76,"phoneExt":77,"email":78},"Study Contact","CONTACT","844-434-4210",null,"Participate-In-This-Study1@its.jnj.com",[80,94,105,115,125,135,145,155,164,174,184,194,204,214,224,233,244,248,257,266,272,281,292,301,310,319,328,339,348,357,368,377,388,393,404,413,422,432,438,444,450,461,467,476,482,493,502,511,517,526,537,546,555,561,567,573],{"facility":81,"status":82,"city":83,"state":84,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":77},"University of California at San Diego Moores Cancer Center","COMPLETED","La Jolla","California","92093","United States","US",{"type":89,"coordinates":90},"Point",[91,92],-117.2742,32.84727,{"lat":92,"lon":91},{"facility":95,"status":96,"city":97,"state":98,"zip":99,"country":86,"countryCode":87,"cosmosGeoPoint":100,"geoPoint":104,"contacts":77},"University of Colorado Denver Anschultz Medical Campus","RECRUITING","Aurora","Colorado","80045",{"type":89,"coordinates":101},[102,103],-104.83192,39.72943,{"lat":103,"lon":102},{"facility":106,"status":96,"city":107,"state":108,"zip":109,"country":86,"countryCode":87,"cosmosGeoPoint":110,"geoPoint":114,"contacts":77},"Yale Cancer Center","New Haven","Connecticut","06520",{"type":89,"coordinates":111},[112,113],-72.92816,41.30815,{"lat":113,"lon":112},{"facility":116,"status":96,"city":117,"state":118,"zip":119,"country":86,"countryCode":87,"cosmosGeoPoint":120,"geoPoint":124,"contacts":77},"The University of Chicago Medical Center (UCMC)","Chicago","Illinois","60637",{"type":89,"coordinates":121},[122,123],-87.65005,41.85003,{"lat":123,"lon":122},{"facility":126,"status":96,"city":127,"state":128,"zip":129,"country":86,"countryCode":87,"cosmosGeoPoint":130,"geoPoint":134,"contacts":77},"University of Maryland School of Medicine","Baltimore","Maryland","21201",{"type":89,"coordinates":131},[132,133],-76.61219,39.29038,{"lat":133,"lon":132},{"facility":136,"status":96,"city":137,"state":138,"zip":139,"country":86,"countryCode":87,"cosmosGeoPoint":140,"geoPoint":144,"contacts":77},"Dana Farber Cancer Institute","Boston","Massachusetts","02115",{"type":89,"coordinates":141},[142,143],-71.05977,42.35843,{"lat":143,"lon":142},{"facility":146,"status":96,"city":147,"state":148,"zip":149,"country":86,"countryCode":87,"cosmosGeoPoint":150,"geoPoint":154,"contacts":77},"University of Michigan Rogel Cancer Center","Ann Arbor","Michigan","48109",{"type":89,"coordinates":151},[152,153],-83.74088,42.27756,{"lat":153,"lon":152},{"facility":156,"status":96,"city":157,"state":148,"zip":158,"country":86,"countryCode":87,"cosmosGeoPoint":159,"geoPoint":163,"contacts":77},"Karmanos Cancer Institute","Detroit","48201 2013",{"type":89,"coordinates":160},[161,162],-83.04575,42.33143,{"lat":162,"lon":161},{"facility":165,"status":96,"city":166,"state":167,"zip":168,"country":86,"countryCode":87,"cosmosGeoPoint":169,"geoPoint":173,"contacts":77},"Washington University School Of Medicine","St Louis","Missouri","63110",{"type":89,"coordinates":170},[171,172],-90.19789,38.62727,{"lat":172,"lon":171},{"facility":175,"status":96,"city":176,"state":177,"zip":178,"country":86,"countryCode":87,"cosmosGeoPoint":179,"geoPoint":183,"contacts":77},"Rutgers Cancer Institute of New Jersey","New Brunswick","New Jersey","08901",{"type":89,"coordinates":180},[181,182],-74.45182,40.48622,{"lat":182,"lon":181},{"facility":185,"status":96,"city":186,"state":187,"zip":188,"country":86,"countryCode":87,"cosmosGeoPoint":189,"geoPoint":193,"contacts":77},"University of North Carolina at Chapel Hill","Chapel Hill","North Carolina","27599",{"type":89,"coordinates":190},[191,192],-79.05584,35.9132,{"lat":192,"lon":191},{"facility":195,"status":96,"city":196,"state":197,"zip":198,"country":86,"countryCode":87,"cosmosGeoPoint":199,"geoPoint":203,"contacts":77},"Cleveland Clinic","Cleveland","Ohio","44195",{"type":89,"coordinates":200},[201,202],-81.69541,41.4995,{"lat":202,"lon":201},{"facility":205,"status":96,"city":206,"state":207,"zip":208,"country":86,"countryCode":87,"cosmosGeoPoint":209,"geoPoint":213,"contacts":77},"University of Utah Huntsman Cancer Institute","Salt Lake City","Utah","84112",{"type":89,"coordinates":210},[211,212],-111.89105,40.76078,{"lat":212,"lon":211},{"facility":215,"status":96,"city":216,"state":217,"zip":218,"country":86,"countryCode":87,"cosmosGeoPoint":219,"geoPoint":223,"contacts":77},"University of Virginia","Charlottesville","Virginia","22903",{"type":89,"coordinates":220},[221,222],-78.47668,38.02931,{"lat":222,"lon":221},{"facility":225,"status":96,"city":226,"state":217,"zip":227,"country":86,"countryCode":87,"cosmosGeoPoint":228,"geoPoint":232,"contacts":77},"Virginia Cancer Specialists","Fairfax","22031",{"type":89,"coordinates":229},[230,231],-77.30637,38.84622,{"lat":231,"lon":230},{"facility":234,"status":96,"city":235,"state":77,"zip":236,"country":237,"countryCode":238,"cosmosGeoPoint":239,"geoPoint":243,"contacts":77},"Beijing Cancer Hospital of Peking University","Beijing","100142","China","CN",{"type":89,"coordinates":240},[241,242],116.39723,39.9075,{"lat":242,"lon":241},{"facility":245,"status":96,"city":246,"state":77,"zip":247,"country":237,"countryCode":238,"cosmosGeoPoint":77,"geoPoint":77,"contacts":77},"West China School of Medicine\u002FWest China Hospital, Sichuan University","Cheng Du Shi","610041",{"facility":249,"status":96,"city":250,"state":77,"zip":251,"country":237,"countryCode":238,"cosmosGeoPoint":252,"geoPoint":256,"contacts":77},"Linyi Cancer Hospital","Linyi","276002",{"type":89,"coordinates":253},[254,255],118.34278,35.06306,{"lat":255,"lon":254},{"facility":258,"status":96,"city":259,"state":77,"zip":260,"country":237,"countryCode":238,"cosmosGeoPoint":261,"geoPoint":265,"contacts":77},"Fudan Cancer Hospital","Shanghai","200032",{"type":89,"coordinates":262},[263,264],121.45806,31.22222,{"lat":264,"lon":263},{"facility":267,"status":96,"city":259,"state":77,"zip":268,"country":237,"countryCode":238,"cosmosGeoPoint":269,"geoPoint":271,"contacts":77},"Shanghai East Hospital","200120",{"type":89,"coordinates":270},[263,264],{"lat":264,"lon":263},{"facility":273,"status":96,"city":274,"state":77,"zip":275,"country":237,"countryCode":238,"cosmosGeoPoint":276,"geoPoint":280,"contacts":77},"Union Hospital Tongji Medical College of Huazhong University of Science and Technology","Wuhan","430022",{"type":89,"coordinates":277},[278,279],114.26667,30.58333,{"lat":279,"lon":278},{"facility":282,"status":96,"city":283,"state":77,"zip":284,"country":285,"countryCode":286,"cosmosGeoPoint":287,"geoPoint":291,"contacts":77},"Institut Sainte Catherine","Avignon","84918","France","FR",{"type":89,"coordinates":288},[289,290],4.80892,43.94834,{"lat":290,"lon":289},{"facility":293,"status":96,"city":294,"state":77,"zip":295,"country":285,"countryCode":286,"cosmosGeoPoint":296,"geoPoint":300,"contacts":77},"Centre Oscar Lambret","Lille","59000",{"type":89,"coordinates":297},[298,299],3.05512,50.63391,{"lat":299,"lon":298},{"facility":302,"status":96,"city":303,"state":77,"zip":304,"country":285,"countryCode":286,"cosmosGeoPoint":305,"geoPoint":309,"contacts":77},"CHU Nantes","Nantes","44000",{"type":89,"coordinates":306},[307,308],-1.55336,47.21725,{"lat":308,"lon":307},{"facility":311,"status":96,"city":312,"state":77,"zip":313,"country":285,"countryCode":286,"cosmosGeoPoint":314,"geoPoint":318,"contacts":77},"Institut Curie","Paris","75248",{"type":89,"coordinates":315},[316,317],2.3488,48.85341,{"lat":317,"lon":316},{"facility":320,"status":96,"city":321,"state":77,"zip":322,"country":285,"countryCode":286,"cosmosGeoPoint":323,"geoPoint":327,"contacts":77},"Gustave Roussy","Villejuif","94805",{"type":89,"coordinates":324},[325,326],2.35992,48.7939,{"lat":326,"lon":325},{"facility":329,"status":96,"city":330,"state":77,"zip":331,"country":332,"countryCode":333,"cosmosGeoPoint":334,"geoPoint":338,"contacts":77},"Universitaetsklinikum Essen","Essen","45147","Germany","DE",{"type":89,"coordinates":335},[336,337],7.01228,51.45657,{"lat":337,"lon":336},{"facility":340,"status":82,"city":341,"state":77,"zip":342,"country":332,"countryCode":333,"cosmosGeoPoint":343,"geoPoint":347,"contacts":77},"Universitaetsklinikum Leipzig","Leipzig","04103",{"type":89,"coordinates":344},[345,346],12.37129,51.33962,{"lat":346,"lon":345},{"facility":349,"status":96,"city":350,"state":77,"zip":351,"country":332,"countryCode":333,"cosmosGeoPoint":352,"geoPoint":356,"contacts":77},"Klinikum der Landeshauptstadt Stuttgart","Stuttgart","70174",{"type":89,"coordinates":353},[354,355],9.17702,48.78232,{"lat":355,"lon":354},{"facility":358,"status":96,"city":359,"state":77,"zip":360,"country":361,"countryCode":362,"cosmosGeoPoint":363,"geoPoint":367,"contacts":77},"Aichi Cancer Center","Nagoya","464-8681","Japan","JP",{"type":89,"coordinates":364},[365,366],136.90641,35.18147,{"lat":366,"lon":365},{"facility":369,"status":96,"city":370,"state":77,"zip":371,"country":361,"countryCode":362,"cosmosGeoPoint":372,"geoPoint":376,"contacts":77},"Tokyo Medical University Hospital","Tokyo","160-0023",{"type":89,"coordinates":373},[374,375],139.69171,35.6895,{"lat":375,"lon":374},{"facility":378,"status":96,"city":379,"state":77,"zip":380,"country":381,"countryCode":382,"cosmosGeoPoint":383,"geoPoint":387,"contacts":77},"Pantai Hospital Kuala Lumpur","Kuala Lumpur","59100","Malaysia","MY",{"type":89,"coordinates":384},[385,386],101.68653,3.1412,{"lat":386,"lon":385},{"facility":389,"status":96,"city":379,"state":77,"zip":380,"country":381,"countryCode":382,"cosmosGeoPoint":390,"geoPoint":392,"contacts":77},"University Malaya Medical Centre",{"type":89,"coordinates":391},[385,386],{"lat":386,"lon":385},{"facility":394,"status":96,"city":395,"state":77,"zip":396,"country":397,"countryCode":398,"cosmosGeoPoint":399,"geoPoint":403,"contacts":77},"Uniwersyteckie Centrum Kliniczne","Gdansk","80 214","Poland","PL",{"type":89,"coordinates":400},[401,402],18.64912,54.35227,{"lat":402,"lon":401},{"facility":405,"status":96,"city":406,"state":77,"zip":407,"country":397,"countryCode":398,"cosmosGeoPoint":408,"geoPoint":412,"contacts":77},"Centrum Onkologii Instytut im M Sklodowskiej Curie Oddzial w Gliwicach","Gliwice","44-102",{"type":89,"coordinates":409},[410,411],18.67658,50.29761,{"lat":411,"lon":410},{"facility":414,"status":96,"city":415,"state":77,"zip":416,"country":397,"countryCode":398,"cosmosGeoPoint":417,"geoPoint":421,"contacts":77},"Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy","Warsaw","02 781",{"type":89,"coordinates":418},[419,420],21.01178,52.22977,{"lat":420,"lon":419},{"facility":423,"status":96,"city":424,"state":77,"zip":425,"country":426,"countryCode":77,"cosmosGeoPoint":427,"geoPoint":431,"contacts":77},"Seoul National University Hospital","Seoul","03080","South Korea",{"type":89,"coordinates":428},[429,430],126.9784,37.566,{"lat":430,"lon":429},{"facility":433,"status":96,"city":424,"state":77,"zip":434,"country":426,"countryCode":77,"cosmosGeoPoint":435,"geoPoint":437,"contacts":77},"Severance Hospital Yonsei University Health System","03722",{"type":89,"coordinates":436},[429,430],{"lat":430,"lon":429},{"facility":439,"status":96,"city":424,"state":77,"zip":440,"country":426,"countryCode":77,"cosmosGeoPoint":441,"geoPoint":443,"contacts":77},"Asan Medical Center","05505",{"type":89,"coordinates":442},[429,430],{"lat":430,"lon":429},{"facility":445,"status":96,"city":424,"state":77,"zip":446,"country":426,"countryCode":77,"cosmosGeoPoint":447,"geoPoint":449,"contacts":77},"Samsung Medical Center","06351",{"type":89,"coordinates":448},[429,430],{"lat":430,"lon":429},{"facility":451,"status":96,"city":452,"state":77,"zip":453,"country":454,"countryCode":455,"cosmosGeoPoint":456,"geoPoint":460,"contacts":77},"Hosp Univ Vall D Hebron","Barcelona","08035","Spain","ES",{"type":89,"coordinates":457},[458,459],2.15899,41.38879,{"lat":459,"lon":458},{"facility":462,"status":96,"city":452,"state":77,"zip":463,"country":454,"countryCode":455,"cosmosGeoPoint":464,"geoPoint":466,"contacts":77},"Inst. Cat. Doncologia-H Duran I Reynals","08908",{"type":89,"coordinates":465},[458,459],{"lat":459,"lon":458},{"facility":468,"status":96,"city":469,"state":77,"zip":470,"country":454,"countryCode":455,"cosmosGeoPoint":471,"geoPoint":475,"contacts":77},"Hosp. Univ. Ramon Y Cajal","Madrid","28034",{"type":89,"coordinates":472},[473,474],-3.70256,40.4165,{"lat":474,"lon":473},{"facility":477,"status":96,"city":469,"state":77,"zip":478,"country":454,"countryCode":455,"cosmosGeoPoint":479,"geoPoint":481,"contacts":77},"Hosp. Univ. 12 de Octubre","28041",{"type":89,"coordinates":480},[473,474],{"lat":474,"lon":473},{"facility":483,"status":96,"city":484,"state":77,"zip":485,"country":486,"countryCode":487,"cosmosGeoPoint":488,"geoPoint":492,"contacts":77},"Changhua Christian Hospital","Changhua","500","Taiwan","TW",{"type":89,"coordinates":489},[490,491],120.5512,24.0692,{"lat":491,"lon":490},{"facility":494,"status":96,"city":495,"state":77,"zip":496,"country":486,"countryCode":487,"cosmosGeoPoint":497,"geoPoint":501,"contacts":77},"Kaohsiung Chang Gung Memorial Hospital","Kaohsiung City","833",{"type":89,"coordinates":498},[499,500],120.31333,22.61626,{"lat":500,"lon":499},{"facility":503,"status":96,"city":504,"state":77,"zip":505,"country":486,"countryCode":487,"cosmosGeoPoint":506,"geoPoint":510,"contacts":77},"National Taiwan University Hospital","Taipei","100",{"type":89,"coordinates":507},[508,509],121.52639,25.05306,{"lat":509,"lon":508},{"facility":512,"status":96,"city":504,"state":77,"zip":513,"country":486,"countryCode":487,"cosmosGeoPoint":514,"geoPoint":516,"contacts":77},"Taipei Veterans General Hospital","112",{"type":89,"coordinates":515},[508,509],{"lat":509,"lon":508},{"facility":518,"status":96,"city":519,"state":77,"zip":520,"country":486,"countryCode":487,"cosmosGeoPoint":521,"geoPoint":525,"contacts":77},"Linkou Chang Gung Memorial Hospital","Taoyuan","33382",{"type":89,"coordinates":522},[523,524],121.29696,24.99368,{"lat":524,"lon":523},{"facility":527,"status":96,"city":528,"state":77,"zip":529,"country":530,"countryCode":531,"cosmosGeoPoint":532,"geoPoint":536,"contacts":77},"Addenbrooke's Hospital","Cambridge","CB2 0QQ","United Kingdom","UK",{"type":89,"coordinates":533},[534,535],0.11667,52.2,{"lat":535,"lon":534},{"facility":538,"status":96,"city":539,"state":77,"zip":540,"country":530,"countryCode":531,"cosmosGeoPoint":541,"geoPoint":545,"contacts":77},"The Royal Surrey County Hospital NHS Foundation Trust","Guildford","GU2 7XX",{"type":89,"coordinates":542},[543,544],-0.57427,51.23536,{"lat":544,"lon":543},{"facility":547,"status":96,"city":548,"state":77,"zip":549,"country":530,"countryCode":531,"cosmosGeoPoint":550,"geoPoint":554,"contacts":77},"Royal Marsden Hospital (Sutton)","London","SM2 5PT",{"type":89,"coordinates":551},[552,553],-0.12574,51.50853,{"lat":553,"lon":552},{"facility":556,"status":96,"city":548,"state":77,"zip":557,"country":530,"countryCode":531,"cosmosGeoPoint":558,"geoPoint":560,"contacts":77},"Royal Marsden Hospital","SW3 6JJ",{"type":89,"coordinates":559},[552,553],{"lat":553,"lon":552},{"facility":562,"status":96,"city":548,"state":77,"zip":563,"country":530,"countryCode":531,"cosmosGeoPoint":564,"geoPoint":566,"contacts":77},"Imperial College London and Imperial College Healthcare NHS Trust","W12 0HS",{"type":89,"coordinates":565},[552,553],{"lat":553,"lon":552},{"facility":568,"status":96,"city":548,"state":77,"zip":569,"country":530,"countryCode":531,"cosmosGeoPoint":570,"geoPoint":572,"contacts":77},"University College London Hospitals","W1T 7HA",{"type":89,"coordinates":571},[552,553],{"lat":553,"lon":552},{"facility":574,"status":96,"city":575,"state":77,"zip":576,"country":530,"countryCode":531,"cosmosGeoPoint":577,"geoPoint":581,"contacts":77},"The Christie Nhs Foundation Trust","Manchester","M20 4BX",{"type":89,"coordinates":578},[579,580],-2.23743,53.48095,{"lat":580,"lon":579},{"type":583,"investigatorFullName":77,"investigatorTitle":77,"investigatorAffiliation":77,"oldNameTitle":77,"oldOrganization":77},"SPONSOR","100545682","phase-1-a-study-of-amivantamab-alone-or-in-addition-to-other-treatment-agents-in-participants-with-head-and-neck-cancer-100545682",false,"NCT06385080","A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer","A Phase 1b\u002F2, Open-label Study of Amivantamab Monotherapy and Amivantamab in Addition to Other Therapeutic Agents in Participants With Head and Neck Squamous Cell Carcinoma","OrigAMI-4","Inclusion Criteria:\n\n* Cohorts 1 to 5: Have histologically or cytologically confirmed recurrent\u002Fmetastatic head and neck squamous cell carcinoma (R\u002FM HNSCC) that is considered incurable by local therapies or for Cohort 6: have histologically or cytologically confirmed locally advanced (L\u002FA) HNSCC that is considered curable by surgery Acceptable prior lines of therapy will be determined according to specific cohort 1, 2, 3A and 3B: (a) The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, or larynx; (b) Any known p16 status of tumor must be negative (Note: All participants with an oropharyngeal tumor must have results of p16 status, per local testing); (c) Participants must provide local testing results of programmed cell death ligand 1 (PD-L1) status, if available; Cohort 4: (d) Patients must have primary tumor location in oropharynx. Unknown primary tumors are not included (e) Primary tumor must be HPV-positive, confirmed by positive p16 test or high-risk human papillomavirus (HPV) in-situ hybridization (ISH) in tissue (current or archival) (f) Participants must provide local testing results of PD-L1 status, if available; Cohort 5 (g) The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, or larynx; (h) HPV status must be known (either positive or negative) for patients with primary tumor location in oropharynx with p16 test or high-risk HPV ISH in tissue; (i) Participants must provide local testing results of PD-L1 status; Cohort 6: (j) The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, or larynx; (k) Any known p16 status of tumor must be negative Note: All participants with an oropharyngeal tumor must have results of p16 status, per local testing Participants must provide local testing results of PD-L1 status (l) Participants must have Stage III or IVa disease (American Joint Committee on Cancer Staging Manual, 8th edition). Participants must have resectable disease\n* Participants in Cohorts 1, 2, 3B, 4 and 5 must have measurable disease according to RECIST version 1.1. Participants in Cohort 3A and Cohort 6 must have evaluable disease (defined as having at least 1 non-target lesion according to RECIST version 1.1.\n* Cohorts 1, 2, 3A, 3B, 4, and 5 only: Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less prior to the first dose of study treatment (except for alopecia or post-radiation skin changes \\[any grade\\], Grade less than or equal to \\[\\\u003C=\\]2 peripheral neuropathy and Grade \\\u003C=2 hypothyroidism stable on hormone replacement)\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n* Participant must have adequate organ and bone marrow function as follows, without history of red blood cell transfusion, platelet transfusion, or use of granulocyte colony-stimulating factor within 7 days prior to the date of the laboratory test.\n\nParticipants should have: a) Hemoglobin \\>=9 grams per deciliter (g\u002FdL); b) Neutrophils \\>=1.5 x 10\\^3\u002Fmcg; c) Platelets \\>=100 x 10\\^3\u002Fmcg\n\nExclusion Criteria:\n\n* Uncontrolled illness including any medical history or current (non-infectious) interstitial lung disease (ILD)\u002F pneumonitis\u002F pulmonary fibrosis, or where suspected ILD\u002Fpneumonitis\u002Fpulmonary fibrosis cannot be ruled out by imaging at screening\n* Participant with untreated brain metastases leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation\n* Participant with a history of clinically significant cardiovascular disease\n* Received prior chemotherapy, targeted cancer therapy, immunotherapy, or treatment with an investigational anticancer agent within 2 weeks or 4 half-lives, whichever is longer, before the first administration of study treatment. The maximum required washout is 28 days\n* Received radiotherapy for palliative purposes within 7 days of the first administration of study treatment","ALL","18 Years",{"count":595,"type":596},287,"ESTIMATED","INTERVENTIONAL",[599,600],"PHASE1","PHASE2","The purpose of this study is to determine safety and preliminary efficacy of amivantamab monotherapy, amivantamab in addition to pembrolizumab, amivantamab in addition to paclitaxel and amivantamab in addition to pembrolizumab and carboplatin in participants with recurrent\u002Fmetastatic head and neck cancer. The study will also confirm the recommended Phase 2 combination dose (RP2CD) for amivantamab in addition to paclitaxel. The safety and preliminary efficacy of amivantamab in addition to pembrolizumab will also be determined in perioperative (before and after surgery) setting in participants with resectable locally advanced head and neck squamous cell carcinoma (HNSCC).",[603],"Squamous Cell Carcinoma of Head and Neck","2026-06-04",{"date":606,"type":607},"2026-06-05","ACTUAL",{"date":609,"type":607},"2024-04-22",{"date":611,"type":596},"2032-12-27",{"name":5,"class":6},56]