[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06162221":3,"trial-entities:NCT06162221":1033,"trial-summary:NCT06162221":1040},{"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":24,"study_type":35,"primary_purpose":36,"phases":37,"enrollment_info":40,"interventions":43,"primary_outcomes":74,"secondary_outcomes":83,"sex":103,"minimum_age":104,"maximum_age":105,"healthy_volunteers":15,"eligibility_criteria":106,"std_ages":121,"locations":124,"central_contacts":1019,"overall_officials":1024,"references":1027,"see_also_links":1032},"NCT06162221","RMC-LUNG-101","Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC","A Platform Study of RAS(ON) Inhibitors in Patients With RAS-Mutated Non-Small Cell Lung Cancer (NSCLC)","RECRUITING","2028-12","2026-06","2026-06-30","2024-01-18","Revolution Medicines, Inc.","INDUSTRY",false,"The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors as a monotherapy or combined with Standard(s) of Care (SOC) or with each other.\n\nThe first four subprotocols include the following:\n\nSubprotocol A: RMC-6291 +\u002F- RMC-6236 + SOC Subprotocol B: RMC-6236 + SOC Subprotocol C: RMC-9805 +\u002F- RMC-6236 + SOC Subprotocol D: RMC-9805","The platform study design allows combinations of RAS(ON) inhibitors with other anticancer agents or as a monotherapy to be evaluated in patients with RAS-mutated solid tumors with a focus on NSCLC.\n\nThis is an open-label platform Phase 1b\u002F2 study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard of Care (SOC), or as a monotherapy and to define the Recommended Phase 2 Dose and Schedule (RP2DS). Enrollment of patients with KRAS or RAS mutations will be specified in each subprotocol.\n\nSubprotocol A is an open-label, multicenter, Phase 1b\u002F2 study of RMC-6291, with or without RMC-6236, in combination with pembrolizumab, with or without chemotherapy, in patients with KRAS G12C-mutated advanced solid tumors.\n\nSubprotocol B is an open-label, multicenter, Phase1b\u002F2 study of RMC-6236 in combination with pembrolizumab, with or without chemotherapy, in patients with RAS-mutated non-small cell lung cancer (NSCLC)\n\nSubprotocol C is an open-label, multicenter, Phase1b\u002F2 study of RMC-9805 with or without RMC-6236, in combination with other anticancer agents, in patients with RAS G12D-mutated non-small cell lung cancer (NSCLC)\n\nSubprotocol D is a Phase 2, Open-label, Multicenter Study of Zoldonrasib (RMC-9805) in Previously Treated Patients with RAS G12D-Mutant Non-Small Cell Lung Cancer (NSCLC)\n\nSubprotocols A, B, and C consist of two parts: Part 1 - Dose Exploration and Part 2 - Dose Expansion. Subprotocol D consists of only one part.",[19,20,21,22,23],"Non-Small Cell Lung Cancer, NSCLC","KRAS, NRAS, HRAS-mutated NSCLC","KRAS G12C-mutated Solid Tumors, Lung Cancer","Lung Cancer Stage IV, Advanced Solid Tumor, Cancer","RAS G12D-mutated NSCLC",[25,26,27,28,29,30,31,32,33,34],"NSCLC","KRAS G12C","RAS Mutation","KRAS G12X","Non-Small Cell Lung Cancer","Lung Cancer","Lung Cancer Stage IV","Advanced Solid Tumor","Cancer","RAS G12D","INTERVENTIONAL","TREATMENT",[38,39],"PHASE1","PHASE2",{"count":41,"type":42},616,"ESTIMATED",[44,50,55,59,62,65,69],{"type":45,"name":46,"description":47,"armGroupLabels":48},"DRUG","RMC-6291","Oral tablet",[49],"Subprotocol A: KRAS G12C-Mutated Solid Tumors",{"type":45,"name":51,"description":47,"armGroupLabels":52},"RMC-6236",[49,53,54],"Subprotocol B: RAS-mutated NSCLC","Subprotocol C: RAS G12D-mutated NSCLC",{"type":45,"name":56,"description":57,"armGroupLabels":58},"Pembrolizumab","IV Infusion",[49,53,54],{"type":45,"name":60,"description":57,"armGroupLabels":61},"Cisplatin",[49,53,54],{"type":45,"name":63,"description":57,"armGroupLabels":64},"Carboplatin",[49,53,54],{"type":45,"name":66,"description":67,"armGroupLabels":68},"Pemetrexed","IV infusion",[49,53,54],{"type":45,"name":70,"description":71,"armGroupLabels":72},"RMC-9805","Oral Tablet",[54,73],"Subprotocol D: RAS G12D-mutated NSCLC",[75,79],{"measure":76,"description":77,"timeFrame":78},"Adverse events","Incidence and severity of treatment-emergent Adverse Events (AEs) and serious AEs and clinically significant changes in laboratory values, ECGs and vital signs","Up to 5 years",{"measure":80,"description":81,"timeFrame":82},"Dose limiting toxicities","Number of participants with dose limiting toxicities","21 days",[84,88,91,94,97,100],{"measure":85,"description":86,"timeFrame":87},"Drug concentrations over time","Observed blood concentration of each drug as applicable per subprotocol","Up to 21 weeks",{"measure":89,"description":90,"timeFrame":87},"Cmax","Maximum observed blood concentration of each drug as applicable per subprotocol",{"measure":92,"description":93,"timeFrame":87},"Tmax","Time to reach maximum blood concentration of each drug as applicable per subprotocol",{"measure":95,"description":96,"timeFrame":87},"AUC","Area under the concentration-time curve of each drug as applicable per subprotocol",{"measure":98,"description":99,"timeFrame":78},"ORR","Objective Response Rate per RECIST v1.1",{"measure":101,"description":102,"timeFrame":78},"DOR","Duration of Response per RECIST v1.1","ALL","18 Years",null,{"inclusion":107,"exclusion":115,"raw_text":120},[108,109,110,111,112,113,114],"≥ 18 years of age","ECOG PS is 0 to 1","Adequate organ function as outlined by the study","Received prior standard therapy appropriate for tumor type and stage","Must have pathologically documented, locally advanced or metastatic KRAS G12C-mutated solid tumor malignancy (not amenable to curative surgery) (Subprotocol A)","Must have pathologically documented, locally advanced or metastatic RAS-mutated NSCLC (Subprotocol B)","Must have pathologically documented, locally advanced or metastatic RAS G12D-mutated NSCLC (Subprotocol C and Subprotocol D)",[116,117,118,119],"Primary central nervous system (CNS) tumors","Impaired gastrointestinal (GI) function that may significantly alter the absorption of RMC drugs","Major surgery \\\u003C 28 days of first dose","Active or history of interstitial lung disease (ILD) or pneumonitis requiring steroids","Inclusion criteria:\n\nAll Patients (unless otherwise noted):\n\n* ≥ 18 years of age\n* ECOG PS is 0 to 1\n* Adequate organ function as outlined by the study\n* Received prior standard therapy appropriate for tumor type and stage\n* Must have pathologically documented, locally advanced or metastatic KRAS G12C-mutated solid tumor malignancy (not amenable to curative surgery) (Subprotocol A)\n* Must have pathologically documented, locally advanced or metastatic RAS-mutated NSCLC (Subprotocol B)\n* Must have pathologically documented, locally advanced or metastatic RAS G12D-mutated NSCLC (Subprotocol C and Subprotocol D)\n\nExclusion criteria:\n\nAll Patients:\n\n* Primary central nervous system (CNS) tumors\n* Impaired gastrointestinal (GI) function that may significantly alter the absorption of RMC drugs\n* Major surgery \\\u003C 28 days of first dose\n* Active or history of interstitial lung disease (ILD) or pneumonitis requiring steroids\n\nOther inclusion\u002Fexclusion criteria may apply.",[122,123],"ADULT","OLDER_ADULT",[125,134,148,160,172,184,195,206,214,227,240,252,264,277,290,303,311,323,332,340,350,361,372,380,387,400,412,425,433,442,449,456,464,472,480,489,497,504,518,531,544,553,566,573,580,592,599,603,615,627,639,649,662,672,684,695,705,717,728,736,740,753,760,768,775,787,796,803,815,822,829,840,849,857,865,870,875,888,895,908,915,926,933,937,945,952,964,976,985,994,1001,1008,1015],{"facility":126,"status":8,"city":127,"state":128,"zip":129,"country":130,"geoPoint":131},"Banner MD Anderson Cancer Center","Gilbert","Arizona","85234","United States",{"lat":132,"lon":133},33.35283,-111.78903,{"facility":135,"status":8,"city":136,"state":137,"zip":138,"country":130,"contacts":139,"geoPoint":145},"City of Hope - Duarte","Duarte","California","91010",[140],{"name":141,"role":142,"phone":143,"email":144},"Taylor Alexander","CONTACT","877-467-3411","taalexander@coh.org",{"lat":146,"lon":147},34.13945,-117.97729,{"facility":149,"status":8,"city":150,"state":137,"zip":151,"country":130,"contacts":152,"geoPoint":157},"City of Hope - Lennar","Irvine","92618",[153],{"name":154,"role":142,"phone":155,"email":156},"Stephanie Casal","866-442-9785","scasal@coh.org",{"lat":158,"lon":159},33.66946,-117.82311,{"facility":161,"status":8,"city":162,"state":137,"zip":163,"country":130,"contacts":164,"geoPoint":169},"UC Davis, Davis Comprehensive Cancer Center","Sacramento","95817",[165],{"name":166,"role":142,"phone":167,"email":168},"Thanina Amirat","916-734-3186","tamirat@ucdavis.edu",{"lat":170,"lon":171},38.58157,-121.4944,{"facility":173,"status":8,"city":174,"state":137,"zip":175,"country":130,"contacts":176,"geoPoint":181},"University of California, San Diego Moores Cancer Center","San Diego","92037",[177],{"name":178,"role":142,"phone":179,"email":180},"Kathy 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Springs","Colorado","80909",{"lat":212,"lon":213},38.83388,-104.82136,{"facility":215,"status":8,"city":216,"state":217,"zip":218,"country":130,"contacts":219,"geoPoint":224},"Georgetown University Medical Center","Washington D.C.","District of Columbia","20007",[220],{"name":221,"role":142,"phone":222,"email":223},"Shannon Raue","202-784-5097","sr1657@georgetown.edu",{"lat":225,"lon":226},38.89511,-77.03637,{"facility":228,"status":8,"city":229,"state":230,"zip":231,"country":130,"contacts":232,"geoPoint":237},"Boca Raton Clinical Research Associates","Plantation","Florida","33322",[233],{"name":234,"role":142,"phone":235,"email":236},"Sandra Perez","561-447-0614","sperez@brcrglobal.com",{"lat":238,"lon":239},26.13421,-80.23184,{"facility":241,"status":8,"city":242,"state":230,"zip":243,"country":130,"contacts":244,"geoPoint":249},"Cancer Specialists of North Florida","Saint Augustine","32086",[245],{"name":246,"role":142,"phone":247,"email":248},"Justin Elkins","904-538-4488","Justin.Elkins@CSNF.us",{"lat":250,"lon":251},29.89469,-81.31452,{"facility":253,"status":8,"city":254,"state":230,"zip":255,"country":130,"contacts":256,"geoPoint":261},"H Lee Moffitt Cancer Center and Research Institute","Tampa","33612",[257],{"name":258,"role":142,"phone":259,"email":260},"Ana Aminpour","813-745-0287","anahid.aminpour@moffitt.org",{"lat":262,"lon":263},27.94752,-82.45843,{"facility":265,"status":8,"city":266,"state":267,"zip":268,"country":130,"contacts":269,"geoPoint":274},"Dana Farber Cancer Institute","Boston","Massachusetts","02215",[270],{"name":271,"role":142,"phone":272,"email":273},"Thoracic KRAS Referrals","877-442-3324","dfcitopkrasmetclinicalresearch@partners.org",{"lat":275,"lon":276},42.35843,-71.05977,{"facility":278,"status":8,"city":279,"state":280,"zip":281,"country":130,"contacts":282,"geoPoint":287},"Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)","Detroit","Michigan","48202",[283],{"name":284,"role":142,"phone":285,"email":286},"Dalia Abdullah","313-874-7518","dabdull3@hfhs.org",{"lat":288,"lon":289},42.33143,-83.04575,{"facility":291,"status":8,"city":292,"state":293,"zip":294,"country":130,"contacts":295,"geoPoint":300},"Intermountain Health - St. Vincent Frontier Cancer Center","Billings","Montana","59102",[296],{"name":297,"role":142,"phone":298,"email":299},"Heather Duyck","406-238-6290","peaks_mtresearch@imail.org",{"lat":301,"lon":302},45.78329,-108.50069,{"facility":304,"status":8,"city":305,"state":306,"zip":307,"country":130,"geoPoint":308},"Nebraska Cancer Specialist","Grand Island","Nebraska","68803",{"lat":309,"lon":310},40.92501,-98.34201,{"facility":312,"status":8,"city":313,"state":313,"zip":314,"country":130,"contacts":315,"geoPoint":320},"New York University Langone Health","New York","10016",[316],{"name":317,"role":142,"phone":318,"email":319},"Salman Punekar","212-731-6228","Salman.punekar@nyulangone.org",{"lat":321,"lon":322},40.71427,-74.00597,{"facility":324,"status":8,"city":313,"state":313,"zip":325,"country":130,"contacts":326,"geoPoint":331},"Icahn School of Medicine at Mount Sinai","10029",[327],{"name":328,"role":142,"phone":329,"email":330},"Jessica Setal-Hunte","212-241-2293","jessica.setal@mssm.edu",{"lat":321,"lon":322},{"facility":333,"status":8,"city":313,"state":313,"zip":334,"country":130,"contacts":335,"geoPoint":339},"Columbia University Medical Center","10032",[336],{"role":142,"phone":337,"email":338},"212-342-5162","Cancerclinicaltrials@cumc.columbia.edu",{"lat":321,"lon":322},{"facility":341,"status":8,"city":342,"state":313,"zip":343,"country":130,"contacts":344,"geoPoint":347},"Clinical Research Alliance","Westbury","11590",[345],{"role":142,"phone":346},"516-488-2918",{"lat":348,"lon":349},40.75566,-73.58763,{"facility":351,"status":8,"city":352,"state":353,"zip":354,"country":130,"contacts":355,"geoPoint":358},"University Hospitals Cleveland Medical Center","Cleveland","Ohio","44106",[356],{"role":142,"phone":357},"216-844-3951",{"lat":359,"lon":360},41.4995,-81.69541,{"facility":362,"status":8,"city":363,"state":364,"zip":365,"country":130,"contacts":366,"geoPoint":369},"UPMC Hillman Cancer Center","Pittsburgh","Pennsylvania","15232",[367],{"role":142,"email":368},"iddcreferrals@upmc.edu",{"lat":370,"lon":371},40.44062,-79.99589,{"facility":373,"status":8,"city":374,"state":375,"zip":376,"country":130,"geoPoint":377},"Baptist Medical Center","Memphis","Tennessee","38120",{"lat":378,"lon":379},35.14953,-90.04898,{"facility":381,"status":8,"city":382,"state":375,"zip":383,"country":130,"geoPoint":384},"Tennessee Oncology","Nashville","37203",{"lat":385,"lon":386},36.16589,-86.78444,{"facility":388,"status":8,"city":389,"state":390,"zip":391,"country":130,"contacts":392,"geoPoint":397},"The University of Texas MD Anderson Cancer Center","Houston","Texas","77030",[393],{"name":394,"role":142,"phone":395,"email":396},"Alison Shaw","713-563-1235","ANTran1@mdanderson.org",{"lat":398,"lon":399},29.76328,-95.36327,{"facility":401,"status":8,"city":402,"state":390,"zip":403,"country":130,"contacts":404,"geoPoint":409},"NEXT Oncology Dallas","Irving","75039",[405],{"name":406,"role":142,"phone":407,"email":408},"Idara Ukpong","972-893-8800","iukpong@nextoncology.com",{"lat":410,"lon":411},32.81402,-96.94889,{"facility":413,"status":8,"city":414,"state":415,"zip":416,"country":130,"contacts":417,"geoPoint":422},"NEXT Oncology Virginia","Fairfax","Virginia","22031",[418],{"name":419,"role":142,"phone":420,"email":421},"Blake Patterson","703-783-4505","bpatterson@nextoncology.com",{"lat":423,"lon":424},38.84622,-77.30637,{"facility":426,"status":8,"city":427,"state":428,"zip":429,"country":130,"geoPoint":430},"Fred Hutchinson Cancer Research Center","Seattle","Washington","98109",{"lat":431,"lon":432},47.60621,-122.33207,{"facility":434,"status":8,"city":435,"state":436,"zip":437,"country":438,"geoPoint":439},"Chris O'Brien Lifehouse Hosptial","Camperdown","New South Wales","2050","Australia",{"lat":440,"lon":441},-33.88965,151.17642,{"facility":443,"status":8,"city":444,"state":436,"zip":445,"country":438,"geoPoint":446},"Liverpool Hospital","Liverpool","2170",{"lat":447,"lon":448},-33.91938,150.92588,{"facility":450,"status":8,"city":451,"state":436,"zip":452,"country":438,"geoPoint":453},"Royal North Shore Hospital","St Leonards","2065",{"lat":454,"lon":455},-33.82344,151.19836,{"facility":457,"status":8,"city":458,"state":459,"zip":460,"country":438,"geoPoint":461},"Monash Health","Clayton","Victoria","3168",{"lat":462,"lon":463},-37.91667,145.11667,{"facility":465,"status":8,"city":466,"state":467,"zip":468,"country":438,"geoPoint":469},"Linear Clinical Research","Nedlands","Western Australia","6009",{"lat":470,"lon":471},-31.98184,115.8073,{"facility":473,"status":8,"city":474,"state":475,"zip":476,"country":475,"geoPoint":477},"Universitätsklinikum St. Pölten","Sankt Pölten","Austria","3100",{"lat":478,"lon":479},48.20762,15.63725,{"facility":481,"status":8,"city":482,"state":483,"zip":484,"country":485,"geoPoint":486},"Nemocnice AGEL Novy Jicin a.s","Nový Jičín","Czech Republic","741 01","Czechia",{"lat":487,"lon":488},49.59438,18.01028,{"facility":490,"status":8,"city":491,"zip":492,"country":493,"geoPoint":494},"Rigshospitalet","Copenhagen","2100","Denmark",{"lat":495,"lon":496},55.67594,12.56553,{"facility":498,"status":8,"city":499,"zip":500,"country":493,"geoPoint":501},"Odense University Hospital, Department of Oncology","Odense","5000",{"lat":502,"lon":503},55.39594,10.38831,{"facility":505,"status":8,"city":506,"state":507,"zip":508,"country":509,"contacts":510,"geoPoint":515},"Hospices Civils de Lyon - Hôpital Louis Pradel","Bron","Auvergne-Rhône-Alpes","69500","France",[511],{"name":512,"role":142,"phone":513,"email":514},"Raphaële Guelminger","33 4 72 35 70 74","raphaele.guelminger@chu-lyon.fr",{"lat":516,"lon":517},45.73865,4.91303,{"facility":519,"status":8,"city":520,"state":521,"zip":522,"country":509,"contacts":523,"geoPoint":528},"Centre Georges François Leclerc","Dijon","Bourgogne-Franche-Comté","21079",[524],{"name":525,"role":142,"phone":526,"email":527},"François Ghirighhelli","33 3 80 73 75 06","fghiringhelli@cgfl.fr",{"lat":529,"lon":530},47.31344,5.01391,{"facility":532,"status":8,"city":533,"state":534,"zip":535,"country":509,"contacts":536,"geoPoint":541},"CHU de Lille Institut Cœur Poumon","Lille","Hauts-de-France","59037",[537],{"name":538,"role":142,"phone":539,"email":540},"Eric Wasielewski","33 3 62 94 35 91","eric.wasielewski@chu-lille.fr",{"lat":542,"lon":543},50.63391,3.05512,{"facility":545,"status":8,"city":546,"state":534,"zip":547,"country":509,"contacts":548},"CHU de Nantes","Nantes","44093",[549],{"name":550,"role":142,"phone":551,"email":552},"Jeanne Chen","33 2 40 16 59 30","Jeanne.chen@chu-nantes.fr",{"facility":554,"status":8,"city":555,"state":556,"zip":557,"country":509,"contacts":558,"geoPoint":563},"EDOG - Institut Bergonié","Bordeaux","New Aquitaine","33000",[559],{"name":560,"role":142,"phone":561,"email":562},"Sophie Cousin","33 5 56 33 33 33","s.cousin@bordeaux.unicancer.fr",{"lat":564,"lon":565},44.84124,-0.58046,{"facility":567,"status":8,"city":568,"zip":569,"country":509,"geoPoint":570},"Institut de Cancerologie de Ouest (ICO) - Angers","Angers","49055",{"lat":571,"lon":572},47.47156,-0.55202,{"facility":574,"status":8,"city":575,"zip":576,"country":509,"geoPoint":577},"Ambroise-Paré Hospital","Boulogne","92104",{"lat":578,"lon":579},46.79346,-1.3194,{"facility":581,"status":8,"city":582,"zip":583,"country":509,"contacts":584,"geoPoint":589},"Centre François Baclesse","Caen","14076",[585],{"name":586,"role":142,"phone":587,"email":588},"Hubert Curcio","33 2 31 45 50 50","h.curcio@baclesse.unicancer.fr",{"lat":590,"lon":591},49.18585,-0.35912,{"facility":593,"status":8,"city":594,"zip":595,"country":509,"geoPoint":596},"Hôpital Cochin","Paris","75014",{"lat":597,"lon":598},48.85341,2.3488,{"facility":600,"status":8,"city":594,"zip":601,"country":509,"geoPoint":602},"Hopital Tenon - AP-HP","75020",{"lat":597,"lon":598},{"facility":604,"status":8,"city":605,"zip":606,"country":509,"contacts":607,"geoPoint":612},"Hopital Foch","Suresnes","92150",[608],{"name":609,"role":142,"phone":610,"email":611},"Jaafar 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Discovery of Daraxonrasib (RMC-6236), a Potent and Orally Bioavailable RAS(ON) Multi-selective, Noncovalent Tri-complex Inhibitor for the Treatment of Patients with Multiple RAS-Addicted Cancers. J Med Chem. 2025 Mar 27;68(6):6064-6083. doi: 10.1021\u002Facs.jmedchem.4c02314. Epub 2025 Mar 8.",[],{"nct_id":4,"conditions":1034,"biomarkers":1037},[1035,1036],"Lung Non-Small Cell Carcinoma","Solid Neoplasm",[1038,1039],"GTPase KRas","RAS Family Oncogene",{"nct_id":4,"found":1041,"summary":1042,"prompt_version":1052},true,{"design":1043,"status":1044,"heading":1045,"summary":1046,"follow_up":1047,"word_count":1048,"commitments":1049,"compensation":1050,"drugs_mentioned":1051},"This is an open-label platform study, meaning you and your doctors will know which treatment you are receiving. It is a Phase 1b\u002F2 study, which means it's looking at safety and early signs of effectiveness.","completed","Study of RAS(ON) Inhibitors for Advanced RAS-mutated NSCLC","This study is testing new treatments called RMC-6291 and RMC-6236, alone or with standard treatments like Pembrolizumab, Cisplatin, or Carboplatin. These treatments are for people with advanced non-small cell lung cancer (NSCLC) or other solid tumors that have specific changes in the RAS gene (like KRAS, NRAS, HRAS, or KRAS G12C). The main goals are to see how safe these new treatments are and if they cause any serious side effects. We also want to see if they help shrink tumors. You may be able to join if you are 18 or older, have good organ function, and have already received standard treatments for your cancer. 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