{"preliminary_commentary":{"by_channel":{"x_thread":36,"youtube":6,"podcast":6,"bluesky_thread":3,"x_video":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT04591431\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"name":"ROME","nct_id":"NCT04591431","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=rome-nct04591431. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"ROME","arms":[{"description":"Experimental (TT) Patients will be treated with target therapy and/or immunotherapy according to their genomic profile evidenced by Foundation One test and independently from their type of cancer with one or more drugs of the following list (administered according to the SmPCs or IBs if under development):\n\nTARGET THERAPY: ERLOTINIB (EGFR mutation) TRASTUZUMAB, PERTUZUMAB, TDM1, LAPATINIB (ERBB2 amplifications/mut) EVEROLIMUS (mTOR mutations, AKT mut) VEMURAFENIB, COBIMETINIB (BRAFV600E mutations) ALECTINIB, BRIGATINIB (ALK, RET) PALBOCICLIB (CDK4/6, CDKN2A/p16) PONATINIB (Bcr-abl) VISMODEGIB (SMO/PTCH1) ITACITINIB (JAK mutation) INCB054828 (FGFR1/2/3) IPATASERTIB (PI3K, AKT, PTEN) ENTRECTINIB (NTRK1/2/3 -TRK fusion proteins-, ROS1) ALPELISIB (PI3K, AKT) TEPOTINIB (MET amplification/exon14 skipping mutations) PRALSETINIB (RET) TALAZOPARIB (BRCA1/2, ATM, other HRD status) SELPERCATINIB (RET) IMMUNOTHERAPY: ATEZOLIZUMAB, NIVOLUMAB, IPILIMUMAB (MSI, HIGH TUMOR MUTATIONAL BURDEN, OTHER)","label":"Tailored Therapy","type":"EXPERIMENTAL"},{"description":"Patients will be treated according the current version of the AIOM (Italian Association of Medical Oncology) guidelines for their type of cancer. As an example, patients could be treated with standard chemotherapy and/or targeted therapy according to the histological results.","label":"Standard of Care","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2025-06","type":"ESTIMATED"},"conditions":["Breast Cancer","Gastrointestinal Cancer","Non Small Cell Lung Cancer","Other Cancer"],"enrollment":{"count":400,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Erlotinib","otherNames":[],"type":"DRUG"},{"name":"Trastuzumab","otherNames":[],"type":"DRUG"},{"name":"Trastuzumab emtansine","otherNames":[],"type":"DRUG"},{"name":"Pertuzumab","otherNames":[],"type":"DRUG"},{"name":"Lapatinib","otherNames":[],"type":"DRUG"},{"name":"Everolimus","otherNames":[],"type":"DRUG"},{"name":"Vemurafenib","otherNames":[],"type":"DRUG"},{"name":"Cobimetinib","otherNames":[],"type":"DRUG"},{"name":"Alectinib","otherNames":[],"type":"DRUG"},{"name":"Brigatinib","otherNames":[],"type":"DRUG"},{"name":"Palbociclib","otherNames":[],"type":"DRUG"},{"name":"Ponatinib","otherNames":[],"type":"DRUG"},{"name":"Vismogedib","otherNames":[],"type":"DRUG"},{"name":"Itacitinib","otherNames":[],"type":"DRUG"},{"name":"Ipatasertib","otherNames":[],"type":"DRUG"},{"name":"Entrectinib","otherNames":[],"type":"DRUG"},{"name":"Atezolizumab","otherNames":[],"type":"DRUG"},{"name":"Nivolumab","otherNames":[],"type":"DRUG"},{"name":"Ipilimumab","otherNames":[],"type":"DRUG"},{"name":"Pemigatinib","otherNames":[],"type":"DRUG"},{"name":"Oncology Drugs","otherNames":[],"type":"DRUG"},{"name":"Pralsetinib","otherNames":[],"type":"DRUG"},{"name":"Selpercatinib","otherNames":[],"type":"DRUG"},{"name":"Talazoparib","otherNames":[],"type":"DRUG"},{"name":"Tepotinib","otherNames":[],"type":"DRUG"},{"name":"Alpelisib","otherNames":[],"type":"DRUG"}],"last_update":"2023-10-03","lead_sponsor":"Fondazione per la Medicina Personalizzata","official_title":"The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy","overall_status":"UNKNOWN","phases":["PHASE2"],"primary_completion_date":{"date":"2024-12","type":"ESTIMATED"},"primary_outcomes":[{"measure":"OVERALL RESPONSE RATE (ORR)","timeFrame":"42 months"}],"references":[{"citation":"Marchetti P, Curigliano G, Westphalen CB, Biffoni M, Lonardi S, Scagnoli S, Fornaro L, Guarneri V, De Giorgi U, Ascierto PA, Blandino G, D'Amati G, Aglietta M, Cremolini C, Conte P, Crimini E, Ceracchi M, Pisegna S, Verkhovskaia S, Bordonaro R, Bracarda S, Butturini G, Del Mastro L, DeCensi A, Fabbri A, De Galitiis F, Fenocchio E, Gori S, Metro G, Pessino A, Pozzessere D, Puglisi F, Tamberi S, Zambelli A, Marino D, Capoluongo E, Cappuzzo F, Cerbelli B, Giannini G, Malapelle U, Mazzuca F, Nuti M, Pruneri G, Simmaco M, Strigari L, Tonini G, Savarese A, Adamo V, Quaresmini D, Tagliaferri P, Damiano P, Urbini B, Bengala C, Zaffignani E, Pinto C, Tosoni A, Buffoni L, Maiello E, Mucciarini C, Russo A, Berardi R, Lombardi G, Piancastelli A, Masi G, Bonanno L, Vanella V, Mannozzi F, Martini N, Botticelli A. The role of the molecular tumor board: learnings from the ROME trial. NPJ Precis Oncol. 2026 Apr 10;10(1):213. doi: 10.1038/s41698-026-01386-1.","pmid":"41963505","type":"DERIVED"},{"citation":"Marchetti P, Curigliano G, Biffoni M, Lonardi S, Scagnoli S, Fornaro L, Guarneri V, De Giorgi U, Ascierto PA, Blandino G, D'Amati G, Aglietta M, Cremolini C, Conte P, Crimini E, Ceracchi M, Pisegna S, Verkhovskaia S, Bordonaro R, Bracarda S, Butturini G, Del Mastro L, DeCensi A, Fabbri A, Fenocchio E, Gori S, Metro G, Pessino A, Pozzessere D, Puglisi F, Tamberi S, Zambelli A, Marino D, Capoluongo E, Cappuzzo F, Cerbelli B, Giannini G, Malapelle U, Mazzuca F, Nuti M, Pruneri G, Simmaco M, Strigari L, Tonini G, Martini N, Botticelli A; ROME trial investigators consortia. Genomically matched therapy in advanced solid tumors: the randomized phase 2 ROME trial. Nat Med. 2025 Oct;31(10):3514-3523. doi: 10.1038/s41591-025-03918-x. Epub 2025 Sep 29.","pmid":"41023484","type":"DERIVED"}],"start_date":{"date":"2020-10-07","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy","url":"https://clinicaltrials.gov/study/NCT04591431"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/rome-nct04591431"}