[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"egfr-mutated-nsclc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:egfr-mutated-nsclc":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"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":19,"type":20},76,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28,29],"Solid Tumors","EGFR Exon 20 Insertion Mutations","NSCLC","EGFR-mutated NSCLC",[28,31,32,33,34,35],"EGFR mutations","EGFR exon20","EGFR exon 20 insertion mutations","ORIC-114","Amivantamab","RECRUITING","2026-04-21",{"date":39,"type":40},"2026-04-24","ACTUAL",{"date":42,"type":40},"2025-02-27",{"date":44,"type":20},"2027-12",{"name":46,"class":47},"ORIC Pharmaceuticals","INDUSTRY",4,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100620871","investigation-of-recurrence-mechanisms-to-adjuvant-osimertinib-in-radically-resected-egfr-mutated-nsclc-patients-100620871","NCT07363252","Investigation of REcurrence Mechanisms to Adjuvant osimertINib in Radically Resected EGFR-mutated NSCLC Patients","Investigation of REcurrence Mechanisms to Adjuvant osimertINib in Radically Resected EGFR-mutated NSCLC Patients - REMAIN Study","REMAIN","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of radically resected IB-IIIA NSCLC with EGFR activating mutation\n* Treatment with adjuvant osimertinib (starting from September 2022, date of approval) according to clinical practice\n* Recurrence of disease during or after adjuvant therapy with osimertinib received according to clinical practice\n* Availability of tissue and\u002For liquid biopsy sample collected at the time of recurrence\n* Signed informed consent.\n\n  * Exclusion Criteria:\n* Unavailability of tissue and\u002For liquid biopsy sample collected at the time of recurrence\n* Concomitant synchronous malignancies aside from NSCLC or any concurrent and\u002For active malignancy that has required treatment within 2 years\n* Involvement in the planning and\u002For conduct of the study (applies to both investigator staff and\u002For staff at the study site).",{"count":58,"type":20},100,"OBSERVATIONAL","Retrospective-prospective observational multicentric study including radically resected EGFR-mutated NSCLC patients relapsed during or after adjuvant osimertinib, received according to clinical practice",[29],[29,63,64],"adjuvant osimertinib","Recurrence","2026-04-17",{"date":67,"type":40},"2026-04-22",{"date":69,"type":40},"2026-04-14",{"date":71,"type":20},"2028-12",{"name":73,"class":74},"Gruppo Oncologico Italiano di Ricerca Clinica","OTHER",25]