Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
Start Date
5/6/2025
Completion Date
12/1/2030
Summary
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.
Detailed Description
This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with daraxonrasib will improve progression free survival (PFS) or overall survival (OS) compared to docetaxel chemotherapy in patients with NSCLC who were previously treated. Patients will be randomized in a 1:1 ratio to receive daraxonrasib or docetaxel chemotherapy.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
daraxonrasib
docetaxel
Conditions
Locations
Alabama Oncology
Birmingham, Alabama 35243
United States
MemorialCare Long Beach Medical Center
Long Beach, California 90806
United States
Yale University, Smillow Cancer Center
New Haven, Connecticut 06519
United States
Florida Cancer Specialists & Research Institute - South
Fort Myers, Florida 33901
United States
BRCR Global
Plantation, Florida 33322
United States
Cancer Care Centers of Breevard
Rockledge, Florida 32955
United States
Florida Cancer Specialists & Research Institute - North
St. Petersburg, Florida 33705
United States
Cleveland Clinic Martin North
Stuart, Florida 34994
United States
Florida Cancer Specialists & Research Institute - East
West Palm Beach, Florida 33401
United States
University Cancer and Blood Center
Athens, Georgia 30607
United States
Piedmont Healthcare, Inc
Atlanta, Georgia 30318
United States
Winship Cancer Institute
Atlanta, Georgia 30322
United States
Center for Care and Discovery
Chicago, Illinois 60637
United States
University of Iowa Health Care Cancer Services Quad Cities
Bettendorf, Iowa 52722
United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa 52242
United States
University of Iowa Health Care, Mission Cancer + Blood
Waukee, Iowa 50263
United States
The University of Kansas Cancer Center
Westwood, Kansas 66205
United States
Johns Hopkins University of Medicine
Baltimore, Maryland 21224
United States
Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Henry Ford Health
Detroit, Michigan 48202
United States
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri 63110
United States
St. Vincent Frontier Cancer Center
Billings, Montana 59102
United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756
United States
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey 07601
United States
Morristown Medical Center (MMCORC)
Morristown, New Jersey 07960
United States
Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Montefiore Medical Center
The Bronx, New York 10461
United States
UNC Lineberger Comprehensive Cancer Center at University of North Carolina
Chapel Hill, North Carolina 27599
United States
TriHealth Cancer & Blood Institute Research
Cincinnati, Ohio 45220
United States
Taylor Cancer Research Center
Maumee, Ohio 43537
United States
Oncology Associates of Oregon PC
Eugene, Oregon 97401
United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033
United States
Avera Saint Luke's Hospital
Aberdeen, South Dakota 57401
United States
Avera Cancer Institute
Sioux Falls, South Dakota 57105
United States
SCRI Oncology Partners - Tennessee
Nashville, Tennessee 37203
United States
Texas Oncology - South Austin
Austin, Texas 78745
United States
Texas Oncology Dallas
Dallas, Texas 75251
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
Texas Oncology - Gulf Coast
The Woodlands, Texas 77380
United States
Utah Cancer Specialists
Salt Lake City, Utah 84106
United States
Huntsman Cancer Institute
Salt Lake City, Utah 84112
United States
Virginia Cancer Specialists
Fairfax, Virginia 22031
United States
Blacktown Medical Oncology Research, Blacktown Hospital
Blacktown, New South Wales 2148
Australia
Blacktown Medical Oncology Research
Blacktown, New South Wales 2148
Australia
Chris O'Brien Lifehouse
Camperdown, New South Wales 2050
Australia
St. George Private Hospital Clinical Trials Unit
Kogarah, New South Wales 2217
Australia
Calvary Mater Newcastle
Waratah, New South Wales 2298
Australia
Mater Misericordiae Limited
South Brisbane, Queensland 4101
Australia
Alfred House
Melbourne, Victoria 3004
Australia
Sir Charles Gairdner Hospital
Perth, Western Australia 6009
Australia
Institut Jules Bordet
Anderlecht, Belgium 1070
Belgium
Grand Hôpital de Charleroi - Les Viviers
Gilly, 6060
Belgium
AZ Groeninge
Kortrijk, 8500
Belgium
UZ Leuven-Campus Gasthuisberg
Leuven, 3000
Belgium
AZ Delta
Roeselare, 8800
Belgium
CHU Strasbourg - Nouvel Hôpital Civil
Strasbourg, Bas Rhin 67091
France
Hopital Nord - CHU Marseille
Marseille, Bouches-du-Rhône 13915
France
Institut régional du Cancer de Montpellier
Montpellier, Herault 34298
France
CHU Rennes Hôpital Pontchaillou
Rennes, Ille et Vilaine 35033
France
CHU de Grenoble - Hôpital Albert Michallon
La Tronche, Isere 38700
France
CHU Nantes - Hôpital Guillaume et René Laënnec
Saint-Herblain, Loire Atlantique 44805
France
Institut de Cancerologie de l Ouest
Saint-Herblain, Loire Atlantique 44805
France
Centre Leon Berard
Léon, Lyon 69008
France
Hopital Albert Calmette - CHU Lille
Lille, Nord 59037
France
Hôpital Bichat - Claude Bernard
Paris, Paris 75018
France
Hopital Louis Pradel
Bron, Rhone 69677
France
Centre Hospitalier Intercommunal de Créteil
Créteil, Val de Marne 94000
France
Institut Gustave Roussy
Vaillant, Villejuif 94800
France
CHU Brest - Hôpital Morvan
Brest, 29200
France
Institut Bergonie
Gironde, 33076
France
CHU de Toulouse - Hopital Larrey
Toulouse, 31059
France
LKI Lungenfachklinik Immenhausen
Immenhausen, Hesse 34376
Germany
Universitaetsklinikum Essen
Essen, North Rhine-Westphalia 45147
Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, Saxony 01307
Germany
Thoraxklinik Heidelberg gGmbH
Baden, Wuerttemberg 69469
Germany
Klinikum Esslingen GmbH
Baden, 73730
Germany
Evangelische Lungenklinik Berlin
Berlin, 13125
Germany
Hong Kong United Oncology Centre
Hong Kong,
Hong Kong
Queen Mary Hospital
Hong Kong,
Hong Kong
The Chinese University of Hong Kong
Shatin, 00000
Hong Kong
Cork Univeristy Hospital
Cork, Cork T12 DC4A
Ireland
Mater Private Hospital
Dublin, Dublin 7
Ireland
University Hospital Limerick
Cork, Limerick V94 F858
Ireland
Tallaght University Hospital
Dublin, 24
Ireland
Beaumont Hospital Cancer Clinical
Dublin, D09 V2N0
Ireland
Galway University Hospital
Galway, H91 YR71
Ireland
IEO Istituto Europeo di Oncologia
Milan, Milano 20141
Italy
Azienda Socio Sanitaria Territoriale Niguarda
Milan, Milano 21206
Italy
Istituto Clinico Humanitas
Rossano, Milano 20089
Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, Milan 20900
Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, Napoli 80131
Italy
Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)
Pisa, Pisa 56124
Italy
Istituto Nazionale dei Tumori Regina Elena IRCCS
Roma, Roma 00144
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00168
Italy
Aichi Cancer Center Hospital
Nagoya, Aichi-ken 464-8681
Japan
Fujita Health University Hospital
Toyoake-shi, Aichi-ken 470-1192
Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba 277-8577
Japan
NHO Himeji Medical Center
Matsuyama, Ehime 791-0280
Japan
NHO Shikoku Cancer Center
Matsuyama, Ehime 791-0280
Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido 003-0804
Japan
Hyogo Cancer Center
Akashi, Hyōgo 673-8558
Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken 920-8641
Japan
Kanagawa Cancer Center
Yokohama, Kanagawa 241-8515
Japan
Tohoku University Hospital
Sendai, Miyagi 980-8574
Japan
Sendai Kousei Hospital
Sendai, Miyagi 981-0914
Japan
Nara Medical University Hospital
Kashihara-shi, Nara 634-8522
Japan
Niigata Cancer Center
Niigata, Niigata 951-8566
Japan
Kansai Medical University Hospital
Hirakata-shi, Osaka 573-1191
Japan
Kindai University Hospital
Osakasayama-shi, Osaka 589-8511
Japan
Shizuoka Cancer Center
Nagaizumi-chō, Shizuoka 411-8777
Japan
National Cancer Center Hospital
Chuo Ku, Tokyo 104-0045
Japan
Cancer Institute Hospital of JFCR
Koto-Ku, Tokyo 135-8550
Japan
Wakayama Medical University Hospital
Wakayama, Wakayama 641-8510
Japan
Amsterdam UMC, Locatie VUMC
Amsterdam, Netherlands 1081BT
Netherlands
Erasmus Medisch Centrum
Rotterdam, Netherlands 3015AA
Netherlands
Antoni van Leeuwenhoek
Amsterdam, 1066 CX
Netherlands
Maastricht University Medical Center P. Debyelaan 25
Maastricht, 6229
Netherlands
Radboudumc
Nijmegen, 6525 GA
Netherlands
Auckland City Hospital - Cancer and Blood Research
Grafton, Auckland 1023
New Zealand
Klinika Onkologii I Radioterapii UCK
Gdansk, 80-214
Poland
INSTYTUT GENETYKI I IMMMUNOLOGII GENIM sp. z o.o.
Lublin, 29-609
Poland
Med-Polonia Sp. z o.o.
Poznan, 60-693
Poland
Aidport Sp. z o.o.
Skorzewo, 60-185
Poland
Pan American Center for Oncology Trials
San Juan, Puerto Rico 00909
Puerto Rico
National University Hospital
Singapore, Singapore 119074
Singapore
National Cancer Centre Singapore
Singapore, 168583
Singapore
Icon Cancer Centre
Singapore, 574623
Singapore
Ajou University Hospital
Gyeonggi-do, Suwon-si 16499
South Korea
Chungbuk National University Hospital
Cheongju-si, 28644
South Korea
Chonnam National University Hwasun Hospital
Hwasun, 58128
South Korea
Korea University Anam Hospital
Seoul, 02841
South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722
South Korea
Samsung Medical Center
Seoul, 06351
South Korea
Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña 15006
Spain
Hospital Universitari Dexeus
Barcelona, Barcelona 08028
Spain
Hospital Universitario La Paz
Fuencarral-El Pardo, Madrid 28046
Spain
Hospital Universitario HM Madrid Sanchinarro
Madrid, Madrid 28050
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Spain
Universitätsspital Basel
Basel, 4031
Switzerland
HFR Fribourg/Kantonsspital Fribourg
Fribourg, 1708
Switzerland
Kantonsspital St. Gallen
Sankt Gallen, 9000
Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan 100
Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan 704
Taiwan
National Taiwan University Hospital
Taipei, Taiwan 10002
Taiwan
Taipei Medical University Hospital
Taipei, 110
Taiwan
Chang Gung Medical Foundation Linkou
Taoyuan, 333
Taiwan
Royal Marsden Hospital-London
London, Greater London SW3 6JJ
United Kingdom
The Clatterbridge Cancer Centre
Liverpool, Merseyside L7 8YA
United Kingdom
Royal Marsden Hospital-Sutton
Sutton, Surrey SM2 5PT
United Kingdom
Royal Free Hospital
London, W3 2QG
United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX
United Kingdom