[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07185997":3,"trial-entities:NCT07185997":747,"trial-summary:NCT07185997":751},{"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":25,"study_type":67,"primary_purpose":68,"phases":69,"enrollment_info":71,"interventions":74,"primary_outcomes":86,"secondary_outcomes":95,"sex":119,"minimum_age":120,"maximum_age":17,"healthy_volunteers":121,"eligibility_criteria":122,"std_ages":126,"locations":129,"central_contacts":734,"overall_officials":740,"references":745,"see_also_links":746},"NCT07185997","FURMO-006","Study to Evaluate Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of EGFR Inhibitor as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic NSCLC With EGFR P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations","A Global, Phase 3, Randomized, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of Osimertinib or Afatinib as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic Non-Small-Cell Lung Cancer With Epidermal Growth Factor Receptor P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations (ALPACCA)","RECRUITING","2030-12","2026-07","2026-08-03","2025-12-17","ArriVent BioPharma, Inc.","INDUSTRY",true,"Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of firmonertinib at a dose level of 240 mg QD compared to investigator's choice of osimertinib (80 mg QD) or afatinib (40 mg QD) in participants who have locally advanced or metastatic NSCLC with EGFR PACC mutations, and who have not received any prior therapy for advanced disease. Participants will be randomized in a 1:1 ratio to treatment with firmonertinib or osimertinib or afatinib and will take the assigned dose daily.",null,[19,20,21,22,23,24],"Non-Small-Cell Lung Cancer","Metastatic Non-Small-Cell Lung Cancer","Advanced Non-Small-Cell Lung Cancer","EGFR P-Loop and Alpha C-Helix Compressing","EGFR PACC","EGFR Uncommon Mutations",[26,27,28,29,30,5,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66],"Non-Small Cell Lung Cancer (NSCLC)","PACC","Firmonertinib","Furmonertinib","AST2818","Drug-Therapy","Metastatic Non-Small Cell Lung Cancer","Advanced Non-Small Cell Lung Cancer","NSCLC","Osimertinib","Afatinib","metastatic NSCLC first-line treatment","Carcinoma NSCLC","Respiratory tract neoplasms","Bronchial Neoplasms","Protein Kinase Inhibitors","tyrosine kinase inhibitor (TKI)","Alflutinib","Lung neoplasms","EGFR","EGFR kinase domain mutations","EGFR activating mutation","EGFR mutation of unknown significance","Non-classical EGFR mutation","EGFR uncommon mutations","EGFR atypical mutations","G719X","S768I","E709X","E709_T710delinsD","G779F","L747X","V774M","L747P\u002FS","R776C\u002FH","G724S","E736K","I740_K745dup","N771G","K757M\u002FR","V769L\u002FM","INTERVENTIONAL","TREATMENT",[70],"PHASE3",{"count":72,"type":73},480,"ESTIMATED",[75,81],{"type":76,"name":28,"description":77,"armGroupLabels":78,"otherNames":80},"DRUG","240 mg oral, daily firmonertinib tablet",[79],"Firmonertinib 240 mg",[30],{"type":76,"name":82,"description":83,"armGroupLabels":84},"EGFR-TKI inhibitor based on investigator's choice","osimertinib 80 mg oral, daily tablet OR afatinib 40 mg oral, daily tablet",[85],"EGFR-TKI inhibitor osimertinib or afatinib based on investigator's choice",[87,91],{"measure":88,"description":89,"timeFrame":90},"Progression Free Survival (PFS) determined by blinded independent central review (BICR)","PFS is defined as the time from randomization to the first occurrence of disease progression as determined by BICR using RECIST v1.1, or death from any cause, whichever occurs first.","Until progression or death, assessed up to approximately 4 years",{"measure":92,"description":93,"timeFrame":94},"Confirmed overall response rate (ORR) as determined by BICR","Confirmed ORR is defined as the percentage of participants with a confirmed CR or PR based on BICR assessment relative to the total number of participants.","Until progression or death, assessed up to approximately 3 years",[96,100,103,106,109,113,116],{"measure":97,"description":98,"timeFrame":99},"Overall survival (OS)","OS is defined as the time from randomization to death from any cause.","Until death, assessed up to approximately 5 years",{"measure":101,"description":102,"timeFrame":90},"Investigator-assessed PFS","Investigator-assessed PFS is defined as the time from randomization to the first documented disease progression or death, whichever occurs first, based on investigator assessment per RECIST v1.1.",{"measure":104,"description":105,"timeFrame":94},"Investigator-assessed confirmed ORR","Investigator-assessed confirmed ORR is defined as the percentage of participants with a confirmed CR or PR based on investigator assessment relative to the total number of participants.",{"measure":107,"description":108,"timeFrame":90},"Duration of response (DOR)","DOR is defined as the time from first documented evidence of CR or PR until the first documented evidence of disease progression or death, whichever occurs first.",{"measure":110,"description":111,"timeFrame":112},"Time to second Progression-free survival (PFS2)","PFS2 is defined as the time from randomization to second progression (ie, earliest of the subsequent progression events after initiation of a new anti-cancer treatment), or death from any cause, whichever occurs first.","Assessed up to approximately 5 years",{"measure":114,"description":115,"timeFrame":112},"Incidence and severity of adverse events (AEs), as a measure of safety and tolerability of firmonertinib","An AE is defined as any unfavorable or unintended medical occurrence in a trial participant administered a pharmaceutical product, regardless of causal attribution.",{"measure":117,"description":118,"timeFrame":112},"Change from baseline in safety-related clinical laboratory test results","Safety-related laboratory parameters include absolute neutrophil count, hemoglobin, platelet count, albumin, blood urea nitrogen (BUN), chloride, creatinine, potassium, sodium, alkaline phosphatase (ALP), alanine aminotransferase (ALT); aspartate aminotransferase (AST), total bilirubin. Each parameter is measured using its standard unit. Changes in participants' laboratory test values are evaluated by comparing baseline (pre-treatment) results with those obtained at prespecified time points during or following the treatment.","ALL","18 Years",false,{"inclusion":123,"exclusion":124,"raw_text":125},[],[],"Key Eligibility Criteria:\n\n* Histologically or cytologically documented, locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.\n* Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) PACC mutation in tumor tissue or blood from local testing.\n* No prior systemic anticancer therapy regimens received for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR) TKIs, monoclonal antibodies, or bispecific antibodies).\n* Patients who have received prior neo-adjuvant and\u002For adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease must have experienced a treatment free interval of at least 12 months.\n* Patients with asymptomatic CNS metastases are eligible.",[127,128],"ADULT","OLDER_ADULT",[130,139,146,153,160,167,174,182,190,197,205,213,219,227,235,243,250,258,265,272,280,289,296,303,311,320,328,336,343,350,354,363,371,379,387,394,401,405,413,417,424,427,434,440,448,455,464,472,477,485,490,498,505,510,515,519,523,532,540,547,551,555,564,572,579,586,590,594,598,607,614,621,628,635,643,650,657,661,667,674,682,688,696,703,710,714,723,730],{"facility":131,"status":8,"city":132,"state":133,"zip":134,"country":135,"geoPoint":136},"St. Jude Medical Center","Fullerton","California","92835","United States",{"lat":137,"lon":138},33.87029,-117.92534,{"facility":140,"status":8,"city":141,"state":133,"zip":142,"country":135,"geoPoint":143},"USC\u002FNorris Comprehensive Cancer Center","Los Angeles","90033",{"lat":144,"lon":145},34.05223,-118.24368,{"facility":147,"status":8,"city":148,"state":133,"zip":149,"country":135,"geoPoint":150},"Providence St. Joseph Hospital","Orange","92868",{"lat":151,"lon":152},33.78779,-117.85311,{"facility":154,"status":8,"city":155,"state":133,"zip":156,"country":135,"geoPoint":157},"University of California Davis Comprehensive Cancer Center","Sacramento","95817",{"lat":158,"lon":159},38.58157,-121.4944,{"facility":161,"status":8,"city":162,"state":133,"zip":163,"country":135,"geoPoint":164},"UCSF Medical Center-Mission Bay","San Francisco","94158",{"lat":165,"lon":166},37.77493,-122.41942,{"facility":168,"status":8,"city":169,"state":133,"zip":170,"country":135,"geoPoint":171},"Kaiser Permanente Medical Center","Vallejo","94589",{"lat":172,"lon":173},38.10409,-122.25664,{"facility":175,"status":8,"city":176,"state":177,"zip":178,"country":135,"geoPoint":179},"University of Colorado Health","Aurora","Colorado","80045",{"lat":180,"lon":181},39.72943,-104.83192,{"facility":183,"status":8,"city":184,"state":185,"zip":186,"country":135,"geoPoint":187},"Illinois Cancer Specialists","Arlington Heights","Illinois","60005",{"lat":188,"lon":189},42.08836,-87.98063,{"facility":191,"status":8,"city":192,"state":185,"zip":193,"country":135,"geoPoint":194},"University of Illinois Hospital and Health Sciences Systems","Chicago","60612",{"lat":195,"lon":196},41.85003,-87.65005,{"facility":198,"status":8,"city":199,"state":200,"zip":201,"country":135,"geoPoint":202},"Henry Ford Cancer Institute","Detroit","Michigan","48202",{"lat":203,"lon":204},42.33143,-83.04575,{"facility":206,"status":8,"city":207,"state":208,"zip":209,"country":135,"geoPoint":210},"Northwell Health\u002FR.J. 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Wales","2148","Australia",{"lat":287,"lon":288},-33.76667,150.91667,{"facility":290,"status":8,"city":291,"state":283,"zip":292,"country":285,"geoPoint":293},"Chris O'Brien Lifehouse","Camperdown","2050",{"lat":294,"lon":295},-33.88965,151.17642,{"facility":297,"status":8,"city":298,"state":283,"zip":299,"country":285,"geoPoint":300},"GenesisCare North Shore Health Hub","St Leonards","2065",{"lat":301,"lon":302},-33.82344,151.19836,{"facility":304,"status":8,"city":305,"state":306,"zip":307,"country":285,"geoPoint":308},"Austin Health","Heidelberg","Victoria","3084",{"lat":309,"lon":310},-37.75,145.06667,{"facility":312,"status":8,"city":313,"state":314,"zip":315,"country":316,"geoPoint":317},"Alberta Health Services, Tom Baker Cancer Centre","Calgary","Alberta","T2N 4N2","Canada",{"lat":318,"lon":319},51.05011,-114.08529,{"facility":321,"status":8,"city":322,"state":323,"zip":324,"country":316,"geoPoint":325},"BC Cancer Vancouver Centre","Vancouver","British Columbia","V5Z 4E6",{"lat":326,"lon":327},49.24966,-123.11934,{"facility":329,"status":8,"city":330,"state":331,"zip":332,"country":316,"geoPoint":333},"Brampton Civic Hospital, William Osler Health Centre","Brampton","Ontario","L6R 3J7",{"lat":334,"lon":335},43.68341,-79.76633,{"facility":337,"status":8,"city":338,"state":331,"zip":339,"country":316,"geoPoint":340},"The Ottawa Hospital Cancer Centre","Ottawa","K1H 8L6",{"lat":341,"lon":342},45.41117,-75.69812,{"facility":344,"status":8,"city":345,"state":331,"zip":346,"country":316,"geoPoint":347},"Sunnybrook Research Institute","Toronto","M4N 3M5",{"lat":348,"lon":349},43.70643,-79.39864,{"facility":351,"status":8,"city":345,"state":331,"zip":352,"country":316,"geoPoint":353},"Princess Margaret Cancer Centre - University Health Network","M5G 2M9",{"lat":348,"lon":349},{"facility":355,"status":8,"city":356,"state":357,"zip":358,"country":359,"geoPoint":360},"Hospices Civil de Lyon","Bron","Auvergne-Rhône-Alpes","69500","France",{"lat":361,"lon":362},45.73865,4.91303,{"facility":364,"status":8,"city":365,"state":366,"zip":367,"country":359,"geoPoint":368},"Hospital Nord de Marseille","Marseille","Bouches-du-Rhone","13915",{"lat":369,"lon":370},43.29695,5.38107,{"facility":372,"status":8,"city":373,"state":374,"zip":375,"country":359,"geoPoint":376},"Centre Francois Baclesse","Caen","Calvados","14076",{"lat":377,"lon":378},49.18585,-0.35912,{"facility":380,"status":8,"city":381,"state":382,"zip":383,"country":359,"geoPoint":384},"Hopital Larrey","Toulouse","Occitanie","31059",{"lat":385,"lon":386},43.60426,1.44367,{"facility":388,"status":8,"city":389,"zip":390,"country":359,"geoPoint":391},"Centre Leon-Berard","Lyon","69373",{"lat":392,"lon":393},45.74906,4.84789,{"facility":395,"status":8,"city":396,"zip":397,"country":359,"geoPoint":398},"Hopital Nord Guilaume-et-Rene-Laennec CHU de Nantes","Saint-Herblain","44093",{"lat":399,"lon":400},47.21154,-1.651,{"facility":402,"status":8,"city":396,"zip":403,"country":359,"geoPoint":404},"Insitut de Canderologie d I'Ouest","44805",{"lat":399,"lon":400},{"facility":406,"status":8,"city":407,"zip":408,"country":409,"geoPoint":410},"Henry Dunant Hospital Center","Athens","115 26","Greece",{"lat":411,"lon":412},37.98376,23.72784,{"facility":414,"status":8,"city":407,"zip":415,"country":409,"geoPoint":416},"University General Hospital Attikon - General Hospital of West Attica H AGIA VARVARA","124 62",{"lat":411,"lon":412},{"facility":418,"status":8,"city":419,"zip":420,"country":409,"geoPoint":421},"Athens Medical Center S.A., European Interbalkan Medical Center","Thessaloniki","570 01",{"lat":422,"lon":423},40.64072,22.93493,{"facility":425,"status":8,"city":419,"zip":420,"country":409,"geoPoint":426},"Thoracic General Hospital of Athens I Sotiria",{"lat":422,"lon":423},{"facility":428,"status":8,"city":429,"country":430,"geoPoint":431},"Humanity and Health Clinical Trial Centre","Central","Hong Kong",{"lat":432,"lon":433},22.28299,114.15846,{"facility":435,"status":8,"city":430,"zip":436,"country":430,"geoPoint":437},"Queen Mary Hospital","000000",{"lat":438,"lon":439},22.27832,114.17469,{"facility":441,"status":8,"city":442,"zip":443,"country":444,"geoPoint":445},"SOC Oncologia Medica e dei Tumori Immuno-correlati","Aviano","33081","Italy",{"lat":446,"lon":447},46.07056,12.59472,{"facility":449,"status":8,"city":450,"zip":451,"country":444,"geoPoint":452},"Istituto Europeo di Oncologia (IEO)","Milan","20141",{"lat":453,"lon":454},42.78235,12.59836,{"facility":456,"status":8,"city":457,"state":458,"zip":459,"country":460,"geoPoint":461},"Aichi Cancer Center","Nagoya","Aichi-ken","464-8681","Japan",{"lat":462,"lon":463},35.18147,136.90641,{"facility":465,"status":8,"city":466,"state":467,"zip":468,"country":460,"geoPoint":469},"National Cancer Center Hospital East","Kashiwa","Chiba","277-8577",{"lat":470,"lon":471},35.86224,139.97732,{"facility":473,"status":8,"city":474,"state":475,"zip":476,"country":460},"Kurume University Hospital","Kurume-Shi","Fukuoka","830-0011",{"facility":478,"status":8,"city":479,"state":480,"zip":481,"country":460,"geoPoint":482},"National Hospital Organization Hokkaido Cancer Center","Sapporo","Hokkaido","003-0804",{"lat":483,"lon":484},43.06667,141.35,{"facility":486,"status":8,"city":487,"state":488,"zip":489,"country":460},"Hyogo Cancer Center","Akashi-shi","Hyōgo","673-8558",{"facility":491,"status":8,"city":492,"state":493,"zip":494,"country":460,"geoPoint":495},"Miyagi Cancer Center","Natori-shi","Miyagi","981-1293",{"lat":496,"lon":497},38.16667,140.88333,{"facility":499,"status":8,"city":500,"state":500,"zip":501,"country":460,"geoPoint":502},"Niigata Cancer Center Hospital","Niigata","951-8566",{"lat":503,"lon":504},37.92259,139.04125,{"facility":506,"status":8,"city":507,"state":508,"zip":509,"country":460},"Kansai Medical University Hospital","Hirakata-shi","Osaka","573-1191",{"facility":511,"status":8,"city":512,"state":513,"zip":514,"country":460},"Nippon Medical School Hospital","Bunkyo-ku","Tokyo","113-8603",{"facility":516,"status":8,"city":517,"state":513,"zip":518,"country":460},"Tokyo Metropolitan Komagome Hospital","Bunkyō-Ku","113-8677",{"facility":520,"status":8,"city":521,"state":513,"zip":522,"country":460},"National Cancer Center Hospital","Chuo-ku","104-0045",{"facility":524,"status":8,"city":525,"state":526,"zip":527,"country":528,"geoPoint":529},"OncoCar Cancer Centre","Petaling Jaya","Selangor","47810","Malaysia",{"lat":530,"lon":531},3.10726,101.60671,{"facility":533,"status":8,"city":534,"state":535,"zip":536,"country":528,"geoPoint":537},"Hospital Kuala Lumpur","Kuala Lumpur","WP Kuala Lumpur","50586",{"lat":538,"lon":539},3.1412,101.68653,{"facility":541,"status":8,"city":542,"zip":543,"country":542,"geoPoint":544},"National Cancer Centre Singapore","Singapore","168583",{"lat":545,"lon":546},1.28967,103.85007,{"facility":548,"status":8,"city":542,"zip":549,"country":542,"geoPoint":550},"Curie Oncology (Farrer)","217562",{"lat":545,"lon":546},{"facility":552,"status":8,"city":542,"zip":553,"country":542,"geoPoint":554},"Tan Tok Seng Hospital","308433",{"lat":545,"lon":546},{"facility":556,"status":8,"city":557,"state":558,"zip":559,"country":560,"geoPoint":561},"The Catholic University of Korea, St. Vincent's Hospital","Suwon","Gyeonggi-do","16247","South 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Center","06351",{"lat":584,"lon":585},{"facility":599,"status":8,"city":600,"state":601,"zip":602,"country":603,"geoPoint":604},"Hospital Universitari Son Espases","Palma","Balearic Islands","07120","Spain",{"lat":605,"lon":606},39.56939,2.65024,{"facility":608,"status":8,"city":609,"zip":610,"country":603,"geoPoint":611},"Hospital Clinic de Barcelona","Barcelona","08036",{"lat":612,"lon":613},41.38879,2.15899,{"facility":615,"status":8,"city":616,"zip":617,"country":603,"geoPoint":618},"Hospital QuironSalud Malaga","Málaga","29004",{"lat":619,"lon":620},36.72016,-4.42034,{"facility":622,"status":8,"city":623,"zip":624,"country":603,"geoPoint":625},"Hospital Universitario Central de Asturias","Oviedo","33011",{"lat":626,"lon":627},43.36029,-5.84476,{"facility":629,"status":8,"city":630,"zip":631,"country":603,"geoPoint":632},"Hospital Universitario y Politecnico La 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Hospital","Bangkoknoi","Bangkok","10700","Thailand",{"facility":668,"status":8,"city":669,"state":664,"zip":670,"country":666,"geoPoint":671},"Chulabhorn Hospital","Lak Si","10210",{"lat":672,"lon":673},13.88724,100.5792,{"facility":675,"status":8,"city":676,"state":677,"zip":678,"country":666,"geoPoint":679},"Prince of Songkla Hospital","Hat Yai","Changwat Songkhla","90110",{"lat":680,"lon":681},7.00836,100.47668,{"facility":683,"status":8,"city":664,"zip":684,"country":666,"geoPoint":685},"Faculty of Medicine Vajira Hospital, Navamindradhiraj University","10300",{"lat":686,"lon":687},13.75398,100.50144,{"facility":689,"status":8,"city":690,"zip":691,"country":692,"geoPoint":693},"Gulhane Training and Research Hospital","Ankara","06010","Turkey (Türkiye)",{"lat":694,"lon":695},39.91987,32.85427,{"facility":697,"status":8,"city":698,"zip":699,"country":692,"geoPoint":700},"Anatalya Province","Antalya","07050",{"lat":701,"lon":702},36.90812,30.69556,{"facility":704,"status":8,"city":705,"zip":706,"country":692,"geoPoint":707},"Medical Park Florya Hospital","Istanbul","34295",{"lat":708,"lon":709},41.01384,28.94966,{"facility":711,"status":8,"city":705,"zip":712,"country":692,"geoPoint":713},"Istinye University Bahcesehir Liv Hospital","34517",{"lat":708,"lon":709},{"facility":715,"status":8,"city":716,"state":717,"zip":718,"country":719,"geoPoint":720},"University College London Hospitals NHS Foundation Trust","London","England","NW1 2PG","United Kingdom",{"lat":721,"lon":722},51.50853,-0.12574,{"facility":724,"status":8,"city":725,"state":717,"zip":726,"country":719,"geoPoint":727},"The Christie NHS Foundation Trust","Manchester","M20 4BX",{"lat":728,"lon":729},53.48095,-2.23743,{"facility":731,"status":8,"city":716,"zip":732,"country":719,"geoPoint":733},"The Royal Marsden NHS Foundation Trust","SW3 6JJ",{"lat":721,"lon":722},[735],{"name":736,"role":737,"phone":738,"email":739},"Clinical Trials","CONTACT","(888) 622-2827","FURMO006CT@arrivent.com",[741],{"name":742,"affiliation":743,"role":744},"Jamuna Thimmarayappa","ArriVent BioPharm","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":748,"biomarkers":750},[749],"Lung Non-Small Cell Carcinoma",[],{"nct_id":4,"found":15,"summary":752,"prompt_version":17},{"design":753,"status":754,"heading":755,"summary":756,"follow_up":757,"word_count":758,"commitments":759,"compensation":760,"drugs_mentioned":761},"This is a global, Phase 3 study where participants will be randomly assigned to receive either firmonertinib or one of the standard treatments. About 480 people are planned to join this study.","completed","Study of Firmonertinib for Advanced NSCLC with EGFR PACC Mutations","This study is testing a drug called firmonertinib against standard treatments (osimertinib or afatinib) for people with advanced non-small cell lung cancer (NSCLC). Your cancer must have a specific change in the EGFR gene called a PACC mutation, which will be checked through a biopsy or blood test. The study aims to see if firmonertinib can slow down cancer growth or shrink tumors more effectively than current treatments. Researchers will compare how long people live without their cancer getting worse (progression-free survival) and how many people see their tumors shrink (overall response rate). This is for people who have not had other treatments for their advanced NSCLC.","Researchers will follow participants until their cancer progresses or they pass away, with assessments for progression-free survival up to approximately 4 years and overall response rate up to approximately 3 years.",107,"Participants will take their assigned medication (firmonertinib, osimertinib, or afatinib) as a daily oral tablet. The study will assess outcomes for up to approximately 4 years.","Not stated in the trial record.",[28]]