[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578876":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":39,"centralContacts":43,"locations":49,"responsibleParty":98,"collaborators":100,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":32,"eligibilityCriteria":110,"healthyVolunteers":106,"sex":111,"minAge":112,"maxAge":32,"enrollmentInfo":113,"targetDuration":32,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":125,"overallStatus":52,"whyStopped":32,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"ORIC Pharmaceuticals","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1 Dose Escalation level 1","EXPERIMENTAL","ORIC-114 + amivantamab",[13],"Drug: ORIC-114 Dose 1 + amivantamab",{"label":15,"type":10,"description":11,"interventionNames":16},"Part 1 Dose Escalation level 2",[17],"Drug: ORIC-114 Dose 2 + amivantamab",{"label":19,"type":10,"description":11,"interventionNames":20},"Part 1 Dose Escalation level 3",[21],"Drug: ORIC-114 Dose 3 + amivantamab",{"label":23,"type":10,"description":24,"interventionNames":25},"Part 2 Dose Expansion","Two potential ORIC-114 dose levels + amivantamab",[17,21],[27,33,36],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","ORIC-114 Dose 1 + amivantamab","ORIC-114 oral daily, amivantamab subcutaneous weekly for 4 weeks followed by every 4 week injection",[9],null,{"type":28,"name":34,"description":30,"armGroupLabels":35,"otherNames":32},"ORIC-114 Dose 2 + amivantamab",[15,23],{"type":28,"name":37,"description":30,"armGroupLabels":38,"otherNames":32},"ORIC-114 Dose 3 + amivantamab",[19,23],[40],{"name":41,"affiliation":5,"role":42},"Pratik S. Multani, MD, MS","STUDY_DIRECTOR",[44],{"name":45,"role":46,"phone":47,"phoneExt":32,"email":48},"ORIC Clinical","CONTACT","650-388-5600","clinical@oricpharma.com",[50,63,73,86],{"facility":51,"status":52,"city":53,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":32},"NYU Langone Health","RECRUITING","New York","10016","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-74.00597,40.71427,{"lat":61,"lon":60},{"facility":64,"status":52,"city":65,"state":66,"zip":67,"country":55,"countryCode":56,"cosmosGeoPoint":68,"geoPoint":72,"contacts":32},"Virginia Cancer Specialists","Fairfax","Virginia","22031",{"type":58,"coordinates":69},[70,71],-77.30637,38.84622,{"lat":71,"lon":70},{"facility":74,"status":75,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":85,"contacts":32},"Peter MacCallum Cancer Centre","NOT_YET_RECRUITING","Melbourne","Victoria","03000","Australia","AU",{"type":58,"coordinates":82},[83,84],144.96332,-37.814,{"lat":84,"lon":83},{"facility":87,"status":75,"city":88,"state":89,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":97,"contacts":32},"The Princess Margaret Hospital","Toronto","Ontario","M5G 1Z5","Canada","CA",{"type":58,"coordinates":94},[95,96],-79.39864,43.70643,{"lat":96,"lon":95},{"type":99,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[101],{"name":102,"class":103},"Janssen Research and Development LLC","UNKNOWN","100578876","phase-1-oric-114-in-combination-with-subcutaneous-amivantamab-in-patients-with-egfr-exon20-insertion-mutant-nsclc-100578876",false,"NCT06816992","ORIC-114 in Combination With Subcutaneous Amivantamab in Patients With EGFR Exon20 Insertion Mutant NSCLC","Phase 1b Study of ORIC-114 in Combination With Amivantamab in Patients With EGFR Exon20 Insertion Mutant NSCLC","Inclusion Criteria:\n\n* Histologically or cytologically confirmed metastatic NSCLC with a documented EGFR exon 20 insertion mutation as determined locally by any nucleic acid-based diagnostic testing method; all tests should be performed in a CLIA certified or equivalently accredited laboratory\n* Prior Therapies:\n\n  1. Dose Escalation: Patients may have previously received and progressed on or after platinum-based chemotherapy or may be treatment naïve\n  2. Dose Expansion: Patients must not have received any prior therapy; at time of enrollment, patients must decline, or be ineligible for all available standard of care therapies with proven benefit\n* Agreement and ability to undergo a pretreatment biopsy, provided the procedure is clinically feasible and not deemed unsafe by the investigator\n* Measurable disease according to RECIST 1.1\n* Patients with asymptomatic CNS metastases are eligible\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Adequate organ function\n\nExclusion Criteria:\n\n* Known small cell lung cancer transformation\n* Leptomeningeal disease\n* Spinal cord compression not definitively treated with surgery or radiation\n* Prior immunotherapy\n* Past medical history of interstitial lung disease (ILD), drug induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD\n* Active gastrointestinal disease (eg, Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would reasonably impact absorption of ORIC-114","ALL","18 Years",{"count":114,"type":115},76,"ESTIMATED","INTERVENTIONAL",[118],"PHASE1","The purpose of this study is to establish the recommended phase 2 dose (RP2D), safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of ORIC-114 in combination with subcutaneous (SC) amivantamab in patients with advanced or metastatic NSCLC harboring an EGFR exon 20 insertion mutation.",[121,122,123,124],"Solid Tumors","EGFR Exon 20 Insertion Mutations","NSCLC","EGFR-mutated NSCLC",[123,126,127,128,129,130],"EGFR mutations","EGFR exon20","EGFR exon 20 insertion mutations","ORIC-114","Amivantamab","2026-04-21",{"date":133,"type":134},"2026-04-24","ACTUAL",{"date":136,"type":134},"2025-02-27",{"date":138,"type":115},"2027-12",{"name":5,"class":6},4]