- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06881784
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301) (RASolve 301)
RASolve 301: Phase 3 Multicenter, Open Label, Randomized Study of RMC-6236 Versus Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic RAS[MUT] NSCLC
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Revolution Medicines Study Director
- Phone Number: 1-844-2-REVMED
- Email: medinfo@revmed.com
Study Locations
-
-
New South Wales
-
Blacktown, New South Wales, Australia, 2148
- Recruiting
- Blacktown Medical Oncology Research
-
Contact:
- Genevieve Grant
- Phone Number: +12 86705069
- Email: genevieve.grant@health.nsw.gov.au
-
Blacktown, New South Wales, Australia, 2148
- Recruiting
- Blacktown Medical Oncology Research, Blacktown Hospital
-
Contact:
- Bo Gao
- Phone Number: 02 9881 8000
-
Camperdown, New South Wales, Australia, 2050
- Recruiting
- Chris O'Brien Lifehouse
-
Contact:
- Maryam Correa
- Phone Number: +61 2 8514 194
- Email: maryam.correa@ih.org
-
Kogarah, New South Wales, Australia, 2217
- Recruiting
- St. George Private Hospital Clinical Trials Unit
-
Contact:
- Tracy Liaw
- Phone Number: 02 8594 5785
- Email: liawt@ramsayhealth.com.au
-
Waratah, New South Wales, Australia, 2298
- Recruiting
- Calvary Mater Newcastle
-
Contact:
- Kerrie Cornall
- Phone Number: 02 4014 3282
- Email: Kerrie.Cornall@health.nsw.gov.au
-
-
Queensland
-
South Brisbane, Queensland, Australia, 4101
- Recruiting
- Mater Misericordiae Limited
-
Contact:
- Bassel Ayoub
- Phone Number: +61731631369
- Email: Bassel.ayoub@mater.org.au
-
Contact:
-
-
Victoria
-
Melbourne, Victoria, Australia, 3004
- Recruiting
- Alfred House
-
Contact:
- Nova Chamen
- Phone Number: 03 9076 9768
- Email: N.Chamen@alfred.org.au
-
-
Western Australia
-
Perth, Western Australia, Australia, 6009
- Recruiting
- Sir Charles Gairdner Hospital
-
Contact:
- Kevin Jasas
- Phone Number: 08 6383 3185
- Email: SCGH.MedOncCTM@health.wa.gov.au
-
-
-
-
-
Gilly, Belgium, 6060
- Recruiting
- Grand Hôpital de Charleroi - Les Viviers
-
Contact:
- Christy VAN DER PERREN
- Email: christy.vanderperren@ghdc.be
-
Kortrijk, Belgium, 8500
- Recruiting
- Az Groeninge
-
Contact:
-
Principal Investigator:
- Sofie Derijcke
-
Leuven, Belgium, 3000
- Recruiting
- UZ Leuven-Campus Gasthuisberg
-
Contact:
- Larissa Cumps
- Phone Number: +32 (0)16 33 84 97
- Email: Larissa.cumps@uzleuven.be
-
Roeselare, Belgium, 8800
- Recruiting
- AZ Delta
-
Contact:
- Melissa Masschelin
- Phone Number: +32 (0)51 23 72 07
- Email: melissa.masschelin@azdelta.be
-
-
Belgium
-
Anderlecht, Belgium, Belgium, 1070
- Recruiting
- Institut Jules Bordet
-
Contact:
- Christelle Swidryk
- Phone Number: +32 (0) 2 541 32 38
- Email: Christelle.swidryk@hubruxelles.be
-
-
-
-
-
Brest, France, 29200
- Recruiting
- CHU Brest - Hopital Morvan
-
Principal Investigator:
- Gilles Quere
-
Contact:
- Email: gilles.quere@chu-brest.fr
-
Gironde, France, 33076
- Recruiting
- Institut Bergonie
-
Contact:
- Sophie Cousin
- Phone Number: +33556333371
- Email: s.cousin@bordeaux.unicancer.fr
-
Toulouse, France, 31059
- Recruiting
- CHU de Toulouse - Hôpital Larrey
-
Contact:
- Mazieres Julien
- Phone Number: +33567771836
- Email: mazieres.j@chu-toulouse.fr
-
-
Bas Rhin
-
Strasbourg, Bas Rhin, France, 67091
- Recruiting
- CHU Strasbourg - Nouvel Hopital Civil
-
Principal Investigator:
- Celine Mascaux
-
Contact:
-
-
Bouches-du-Rhône
-
Marseille, Bouches-du-Rhône, France, 13915
- Recruiting
- Hopital Nord - CHU Marseille
-
Principal Investigator:
- PASCALE TOMASINI
-
Contact:
- Email: pascale.tomasini@ap-hm.fr
-
-
Herault
-
Montpellier, Herault, France, 34298
- Recruiting
- Institut Regional du Cancer de Montpellier
-
Contact:
-
Principal Investigator:
- Thomas Quentin
-
-
Ille et Vilaine
-
Rennes, Ille et Vilaine, France, 35033
- Recruiting
- Chu Rennes Hopital Pontchaillou
-
Contact:
- Email: herve.lena@chu-rennes.fr
-
Principal Investigator:
- Herva Lena
-
-
Isere
-
La Tronche, Isere, France, 38700
- Recruiting
- CHU de Grenoble - Hopital Albert Michallon
-
Principal Investigator:
- Denis Moro-Sibilot
-
Contact:
-
-
Loire Atlantique
-
Saint-Herblain, Loire Atlantique, France, 44805
- Recruiting
- CHU Nantes - Hôpital Guillaume et René Laënnec
-
Principal Investigator:
- Elvire Pons-Tostivint
-
Contact:
- Email: elvire.pons@chu-nantes.fr
-
Saint-Herblain, Loire Atlantique, France, 44805
- Recruiting
- Institut de Cancerologie de l Ouest
-
Contact:
- Sandrine Hiret
- Phone Number: +33240679705
- Email: sandrine.hiret@ico.unicancer.fr
-
-
Lyon
-
Léon, Lyon, France, 69008
- Recruiting
- Centre Léon Bérard
-
Principal Investigator:
- Maurice Perol
-
Contact:
-
-
Nord
-
Lille, Nord, France, 59037
- Recruiting
- Hopital Albert Calmette - CHU Lille
-
Principal Investigator:
- Alexis Cortot
-
Contact:
- Email: alexis.cortot@chu-lille.fr
-
-
Paris
-
Paris, Paris, France, 75018
- Recruiting
- Hôpital Bichat - Claude Bernard
-
Contact:
- Gérard Zalcman
- Phone Number: +33 1 40 25 75 18
- Email: gerard.zalcman@aphp.fr
-
-
Rhone
-
Bron, Rhone, France, 69677
- Recruiting
- Hôpital Louis Pradel
-
Contact:
- Michael Duruisseaux
- Phone Number: +33478863780
- Email: michael.duruisseaux@chu-lyon.fr
-
-
Val de Marne
-
Créteil, Val de Marne, France, 94000
- Recruiting
- Centre Hospitalier Intercommunal de Creteil
-
Principal Investigator:
- Christos Chouaid
-
Contact:
-
-
Villejuif
-
Vaillant, Villejuif, France, 94800
- Recruiting
- Institut Gustave Roussy
-
Contact:
- Fabrice Barlesi
- Phone Number: +33142114899
- Email: fabrice.barlesi@gustaveroussy.fr
-
-
-
-
-
Baden, Germany, 73730
- Recruiting
- Klinikum Esslingen GmbH
-
Contact:
- Faehling Martin
- Phone Number: +4971131032402
- Email: m.faehling@klinikum-esslingen.de
-
Berlin, Germany, 13125
- Recruiting
- Evangelische Lungenklinik Berlin
-
Contact:
- Grohe Christian
- Phone Number: +493094802112
- Email: christian.grohe@jsd.de
-
-
Hesse
-
Immenhausen, Hesse, Germany, 34376
- Recruiting
- Lki Lungenfachklinik Immenhausen
-
Principal Investigator:
- Achim Rittmeyer
-
Contact:
-
-
North Rhine-Westphalia
-
Essen, North Rhine-Westphalia, Germany, 45147
- Recruiting
- Universitaetsklinikum Essen
-
Contact:
- Martin Schuler
- Phone Number: +492017232000
- Email: martin.schuler@uk-essen.de
-
-
Saxony
-
Dresden, Saxony, Germany, 01307
- Recruiting
- Universitaetsklinikum Carl Gustav Carus TU Dresden
-
Contact:
- Felix Saalfeld
- Phone Number: +4935145811924
- Email: felix.saalfeld@ukdd.de
-
-
Wuerttemberg
-
Baden, Wuerttemberg, Germany, 69469
- Recruiting
- Thoraxklinik Heidelberg gGmbH
-
Contact:
- Farastuk Bozorgmehr
- Phone Number: +4962213968077
- Email: farastuk.bozorgmehr@med.uni-heidelberg.de
-
-
-
-
-
Hong Kong, Hong Kong
- Recruiting
- Queen Mary Hospital
-
Contact:
- Victor Lee
- Phone Number: + 852 2255 4352
- Email: oncology@hku.hk
-
Hong Kong, Hong Kong
- Recruiting
- Hong Kong United Oncology Centre
-
Contact:
- Phone Number: +852 2386 8002
- Email: Enquiry@hkuoc.hk
-
Shatin, Hong Kong, 00000
- Recruiting
- The Chinese University of Hong Kong
-
Contact:
- Molly LI
- Phone Number: 35051042
-
-
-
-
-
Dublin, Ireland, D09 V2N0
- Recruiting
- Beaumont Hospital Cancer Clinical
-
Contact:
- Jarushka Naidoo
- Phone Number: +35318092010
- Email: jarushkanaidoo@beaumont.ie
-
-
Cork
-
Cork, Cork, Ireland, T12 DC4A
- Recruiting
- Cork Univeristy Hospital
-
Contact:
- Hazel O'Sullivan
- Phone Number: 021-4922687
- Email: hazel.osullivan@hse.ie
-
-
Dublin
-
Dublin, Dublin, Ireland, 7
- Recruiting
- Mater Private Hospital
-
Contact:
- Phone Number: +35318858888
- Email: Jane.sui@materprivate.ie
-
Principal Investigator:
- Jane Sui
-
-
Limerick
-
Cork, Limerick, Ireland, V94 F858
- Recruiting
- University Hospital Limerick
-
Contact:
- Grzegorz Korpanty
- Phone Number: 0035361482728
- Email: greg.korpanty2@hse.ie
-
-
-
-
-
Rome, Italy, 00168
- Recruiting
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
-
Contact:
- Emilio Bria
- Phone Number: +39630154838
- Email: emilio.bria@policlinicogemelli.it
-
-
Milan
-
Monza, Milan, Italy, 20900
- Recruiting
- Fondazione IRCCS San Gerardo dei Tintori
-
Contact:
- Diego Luigi Cortinovis
- Phone Number: diegoluigi.cortinovis@irccs-sa
-
-
Milano
-
Milan, Milano, Italy, 20141
- Recruiting
- IEO Istituto Europeo di Oncologia
-
Contact:
- Antonio Passaro
- Phone Number: +39257489482
- Email: antonio.passaro@ieo.it
-
Milan, Milano, Italy, 21206
- Recruiting
- Azienda Socio Sanitaria Territoriale Niguarda
-
Contact:
- Diego Signorelli
- Phone Number: +39223903991
- Email: diego.signorelli@ospedaleniguarda.it
-
Rossano, Milano, Italy, 20089
- Recruiting
- Istituto Clinico Humanitas
-
Principal Investigator:
- Luca Toschi
-
Contact:
-
-
Napoli
-
Naples, Napoli, Italy, 80131
- Recruiting
- Istituto Nazionale Tumori Fondazione G. Pascale
-
Principal Investigator:
- Alessandro Morabito
-
Contact:
- Phone Number: +398117770291
- Email: a.morabito@istitutotumori.na.it
-
-
Pisa
-
Pisa, Pisa, Italy, 56124
- Recruiting
- Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)
-
Principal Investigator:
- Iacopo Petrini
-
Contact:
- Phone Number: +3950996653
- Email: iacopo.petrini@gmail.com
-
-
Roma
-
Roma, Roma, Italy, 00144
- Recruiting
- Istituto Nazionale dei Tumori Regina Elena IRCCS
-
Principal Investigator:
- Federico Cappuzzo
-
Contact:
- Email: federico.cappuzzo@ifo.it
-
-
-
-
Aichi-ken
-
Nagoya, Aichi-ken, Japan, 464-8681
- Recruiting
- Aichi Cancer Center Hospital
-
Contact:
- Phone Number: 052-762-6111
-
Toyoake-shi, Aichi-ken, Japan, 470-1192
- Recruiting
- Fujita Health University Hospital
-
Contact:
- Phone Number: 0562-93-2111
-
-
Chiba
-
Kashiwa-shi, Chiba, Japan, 277-8577
- Recruiting
- National Cancer Center Hospital East
-
Contact:
- Phone Number: 04-7133-1111
-
-
Ehime
-
Matsuyama, Ehime, Japan, 791-0280
- Recruiting
- NHO Shikoku Cancer Center
-
Contact:
- Phone Number: 089-999-1111
-
Matsuyama, Ehime, Japan, 791-0280
- Recruiting
- NHO Himeji Medical Center
-
Contact:
- Phone Number: 81 79-225-3211
-
-
Hokkaido
-
Sapporo, Hokkaido, Japan, 003-0804
- Recruiting
- National Hospital Organization Hokkaido Cancer Center
-
Contact:
- Phone Number: +81-11-811-9111
-
-
Hyōgo
-
Akashi, Hyōgo, Japan, 673-8558
- Recruiting
- Hyogo Cancer Center
-
Contact:
- Phone Number: +81-78-929-1151
-
-
Ishikawa-ken
-
Kanazawa, Ishikawa-ken, Japan, 920-8641
- Recruiting
- Kanazawa University Hospital
-
Contact:
- Phone Number: 076-265-2000
-
-
Kanagawa
-
Yokohama, Kanagawa, Japan, 241-8515
- Recruiting
- Kanagawa Cancer Center
-
Contact:
- Phone Number: 045-520-2222
-
-
Miyagi
-
Sendai, Miyagi, Japan, 980-8574
- Recruiting
- Tohoku University Hospital
-
Contact:
- Phone Number: 022-717-7000
-
-
Nara
-
Kashihara-shi, Nara, Japan, 634-8522
- Recruiting
- Nara Medical University Hospital
-
Contact:
- Phone Number: 0744-22-3051
-
-
Niigata
-
Niigata, Niigata, Japan, 951-8566
- Recruiting
- Niigata Cancer Center
-
Contact:
- Phone Number: 025-266-5111
-
-
Osaka
-
Hirakata-shi, Osaka, Japan, 573-1191
- Recruiting
- Kansai Medical University Hospital
-
Contact:
- Phone Number: 072-804-0101
-
Osakasayama-shi, Osaka, Japan, 589-8511
- Recruiting
- Kindai University Hospital
-
Contact:
- Phone Number: 072-366-0221
-
-
Shizuoka
-
Nagaizumi-chō, Shizuoka, Japan, 411-8777
- Recruiting
- Shizuoka Cancer Center
-
Contact:
- Phone Number: 055-989-5222
-
-
Tokyo
-
Chuo Ku, Tokyo, Japan, 104-0045
- Recruiting
- National Cancer Center Hospital
-
Contact:
- Phone Number: +81-3-3542-2511
-
Koto-Ku, Tokyo, Japan, 135-8550
- Recruiting
- Cancer Institute Hospital of JFCR
-
Contact:
- Phone Number: +81-3-3520-0111
-
-
Wakayama
-
Wakayama, Wakayama, Japan, 641-8510
- Recruiting
- Wakayama Medical University Hospital
-
Contact:
- Phone Number: 073-447-2300
-
-
-
-
-
Amsterdam, Netherlands, 1066 CX
- Recruiting
- Antoni van Leeuwenhoek
-
Contact:
- Adrianus de Langen
- Phone Number: 31205127942
-
Maastricht, Netherlands, 6229
- Recruiting
- Maastricht University Medical Center P. Debyelaan 25
-
Contact:
- Lizza Hendricks
- Phone Number: +31433875047
-
Nijmegen, Netherlands, 6525 GA
- Recruiting
- Radboudumc
-
Contact:
- Chantal Smits Van der Graaf
- Email: studies@hospital.nl
-
-
Netherlands
-
Amsterdam, Netherlands, Netherlands, 1081BT
- Recruiting
- Amsterdam UMC, locatie VUmc
-
Contact:
- Sayed Hashemi
- Phone Number: +31204444444
-
Rotterdam, Netherlands, Netherlands, 3015AA
- Recruiting
- Erasmus Medisch Centrum
-
Contact:
- Anne-Marie Dingemans
- Phone Number: +31433876543
-
-
-
-
Auckland
-
Grafton, Auckland, New Zealand, 1023
- Recruiting
- Auckland City Hospital - Cancer and Blood Research
-
Contact:
- Merina Matthew
- Phone Number: Ext 21650 093074949
- Email: merina.mathew@tewhatuora.govt.nz
-
-
-
-
-
Lublin, Poland, 29-609
- Recruiting
- INSTYTUT GENETYKI I IMMMUNOLOGII GENIM sp. z o.o.
-
Principal Investigator:
- Izabela Chmielewska
-
Contact:
- Email: izachm@wp.pl
-
Poznan, Poland, 60-693
- Recruiting
- Med-Polonia Sp. z o.o.
-
Contact:
- Rodryg Ramlau
- Phone Number: +48 513 155 613
- Email: rodrygramlau@gmail.com
-
Skorzewo, Poland, 60-185
- Recruiting
- AIDPORT Sp. z o.o.
-
Contact:
- Email: marcin.bednarek@aidport.pl
-
Principal Investigator:
- Marcin Bednarek
-
-
-
-
Puerto Rico
-
San Juan, Puerto Rico, Puerto Rico, 00909
- Recruiting
- Pan American Center for Oncology Trials
-
Contact:
- Carlos Quijano
- Phone Number: (787) 407-3333
- Email: info@panoncologytrials.com
-
-
-
-
-
Singapore, Singapore, 168583
- Recruiting
- National Cancer Centre Singapore
-
Contact:
- National Cancer Centre Singapore
- Phone Number: +65-6436 8000
- Email: clinical.trials@nccs.com.sg
-
Singapore, Singapore, 574623
- Recruiting
- Icon Cancer Centre
-
Contact:
- ICON Cancer Centre (Research Singapore Team)
- Phone Number: +65-66049919
- Email: researchsingapore@icon.team
-
-
Singapore
-
Singapore, Singapore, Singapore, 119074
- Recruiting
- National University Hospital
-
Contact:
- Haematology-Oncology Research Group (HORG)
- Phone Number: 6908 2222
- Email: horg@nuhs.edu.sg
-
-
-
-
-
Cheongju-si, South Korea, 28644
- Recruiting
- Chungbuk National University Hospital
-
Contact:
- Ki Hyeong Lee
- Phone Number: +82-43-269-6015
- Email: kihlee@chungbuk.ac.kr
-
Hwasun, South Korea, 58128
- Recruiting
- Chonnam National University Hwasun Hospital
-
Contact:
- Young-Chul Kim
- Phone Number: 82-10-3635-2876
- Email: kyc0923@jnu.ac.kr
-
Seoul, South Korea, 03722
- Recruiting
- Severance Hospital, Yonsei University Health System
-
Contact:
- Hye Ryun Kim
- Phone Number: +82-2-2228-8125
- Email: nobelg@yuhs.ac
-
Seoul, South Korea, 06351
- Recruiting
- Samsung Medical Center
-
Contact:
- Se-Hoon Lee
- Phone Number: +82-2-3410-1132
- Email: sehoon.lee119@gmail.com
-
Seoul, South Korea, 02841
- Recruiting
- Korea University Anam Hospital
-
Contact:
- Yoon Ji Choi
- Phone Number: +82-2-920-6267
- Email: yj_choi@korea.ac.kr
-
-
Suwon-si
-
Gyeonggi-do, Suwon-si, South Korea, 16499
- Recruiting
- Ajou University Hospital
-
Contact:
- Hyun-Woo Lee
- Phone Number: +82-31-219-5989
- Email: hwlee71@gmail.com
-
-
-
-
-
Barcelona, Spain, 08041
- Recruiting
- Hospital de la Santa Creu i Sant Pau
-
Contact:
- Andres Barba Joaquin
- Phone Number: +34935565638
- Email: abarba@santpau.cat
-
-
A Coruña
-
A Coruña, A Coruña, Spain, 15006
- Recruiting
- Complejo Hospitalario Universitario A Coruna
-
Contact:
- Ana Carro Ramos
- Phone Number: x292414 +34981178000
- Email: Ana.Carro.Ramos@sergas.es
-
-
Barcelona
-
Barcelona, Barcelona, Spain, 08028
- Recruiting
- Hospital Universitari Dexeus
-
Contact:
- Roxana Reyes
- Phone Number: +34935460135
- Email: rreyes@oncorosell.com
-
-
Madrid
-
Fuencarral-El Pardo, Madrid, Spain, 28046
- Recruiting
- Hospital Universitario La Paz
-
Contact:
- Javier de Castro
- Phone Number: +34917277516
- Email: javier.decastro@salud.madrid.org
-
Madrid, Madrid, Spain, 28050
- Recruiting
- Hospital Universitario Hm Madrid Sanchinarro
-
Contact:
- Gema Garcia Ledo
- Phone Number: +34917567984
- Email: gmgarcialedo@hmhospitales.com
-
-
-
-
-
Basel, Switzerland, 4031
- Recruiting
- Universitatsspital Basel
-
Principal Investigator:
- Benjamin Kasenda
-
Contact:
- Email: benjamin.kasenda@usb.ch
-
Fribourg, Switzerland, 1708
- Recruiting
- Hfr Fribourg/Kantonsspital Fribourg
-
Principal Investigator:
- Alessandra Curioni-Fontecedro
-
Contact:
-
Sankt Gallen, Switzerland, 9000
- Recruiting
- Kantonsspital St. Gallen
-
Contact:
- Email: martin.frueh@h-och.ch
-
Principal Investigator:
- Martin Frueh
-
-
-
-
-
Taipei, Taiwan, 110
- Recruiting
- Taipei Medical University Hospital
-
Contact:
- Chao-Hua Chiu (Lung Patients only)
- Phone Number: 886- 960303216
- Email: chaohuachiu@gmail.com
-
Taoyuan, Taiwan, 333
- Recruiting
- Chang Gung Medical Foundation Linkou
-
Contact:
- Ho-Wen Ko
- Phone Number: 886-9753-68089
- Email: howwenko@gmail.com
-
-
Taiwan
-
Kaohsiung, Taiwan, Taiwan, 100
- Recruiting
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
Contact:
- Mei-Chun Lu
- Phone Number: 5664 +887-7-3121101
- Email: s951627@gmail.com
-
Tainan, Taiwan, Taiwan, 704
- Recruiting
- National Cheng Kung University Hospital
-
Contact:
- Yi-Ying Liu
- Phone Number: 3117 +887-6-2353535
- Email: betty22276@gmail.com
-
Taipei, Taiwan, Taiwan, 10002
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Xiu-Juan Lin
- Phone Number: 268057 +886-2-2312-3456
- Email: linkiki@ntuh.gov.tw
-
-
-
-
-
Manchester, United Kingdom, M20 4BX
- Recruiting
- The Christie NHS Foundation Trust
-
Contact:
- Colin Lindsay
- Phone Number: 441614468125
- Email: the-christie.LungResearchTeam@nhs.net
-
-
Greater London
-
London, Greater London, United Kingdom, SW3 6JJ
- Recruiting
- Royal Marsden Hospital-London
-
Contact:
- Sanjay Popat
- Email: Sanjay.Popat@rmh.nhs.uk
-
-
Merseyside
-
Liverpool, Merseyside, United Kingdom, L7 8YA
- Recruiting
- The Clatterbridge Cancer Centre
-
Contact:
- Carles Escriu
- Phone Number: + 44 7887844080
- Email: carles.escriu@nhs.net
-
-
Surrey
-
Sutton, Surrey, United Kingdom, SM2 5PT
- Recruiting
- Royal Marsden Hospital-Sutton
-
Contact:
- Sanjay Popat
- Email: Sanjay.Popat@rmh.nhs.uk
-
-
-
-
Alabama
-
Birmingham, Alabama, United States, 35243
- Recruiting
- Alabama Oncology
-
Contact:
- Stephanie (Sherbet) Abercrombie, CRC
- Phone Number: 205-803-4369
- Email: Stephanie.Abercrombie@alabamaoncology.com
-
-
California
-
Long Beach, California, United States, 90806
- Recruiting
- MemorialCare Long Beach Medical Center
-
Contact:
- Laura Macias
- Phone Number: 562-706-2701
- Email: LMacias@memorialcare.org
-
-
Connecticut
-
New Haven, Connecticut, United States, 06519
- Recruiting
- Yale University, Smillow Cancer Center
-
Contact:
- Jennifer Pope
- Phone Number: (203) 494-3732
- Email: jennifer.pope@yale.edu
-
-
Florida
-
Fort Myers, Florida, United States, 33901
- Recruiting
- Florida Cancer Specialists & Research Institute - South
-
Contact:
- Martina Bedford
- Phone Number: 727-216-1143
- Email: ResearchProgramManagement@flcancer.com
-
Plantation, Florida, United States, 33322
- Recruiting
- BRCR Global
-
Contact:
- Fabiany Chacin, CRC
- Phone Number: +1 (561) 447-0614
- Email: fabianyc@brcrglobal.com
-
Rockledge, Florida, United States, 32955
- Recruiting
- Cancer Care Centers of Breevard
-
Contact:
- Karla Childers
- Phone Number: 321-725-8300
- Email: karla.childers@usoncology.com
-
St. Petersburg, Florida, United States, 33705
- Recruiting
- Florida Cancer Specialists & Research Institute - North
-
Contact:
- Martina Bedford
- Phone Number: 239-274-9930
- Email: ResearchProgramManagement@flcancer.com
-
Stuart, Florida, United States, 34994
- Recruiting
- Cleveland Clinic Martin North
-
Contact:
- Angelic Gamez
- Phone Number: 772-419-2146
- Email: GamezA3@ccf.org
-
West Palm Beach, Florida, United States, 33401
- Recruiting
- Florida Cancer Specialists & Research Institute - East
-
Contact:
- Martina Bedford
- Phone Number: 561-366-4100
- Email: ResearchProgramManagement@flcancer.com
-
-
Georgia
-
Athens, Georgia, United States, 30607
- Recruiting
- University Cancer and Blood Center
-
Contact:
- Nikki Pope
- Phone Number: 706-353-5006
- Email: research@universitycancer.com
-
Atlanta, Georgia, United States, 30318
- Recruiting
- Piedmont Healthcare, Inc
-
Contact:
- Karma McCants
- Phone Number: 404-425-7938
- Email: karma.mccants@piedmont.org
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- Recruiting
- Center for Care and Discovery
-
Contact:
- Phone Number: 1-855-702-8222
- Email: cancerclinicaltrials@bsd.uchicago.edu
-
-
Kansas
-
Westwood, Kansas, United States, 66205
- Recruiting
- The University of Kansas Cancer Center
-
Contact:
- Phone Number: 913-945-7552
- Email: CTNurseNav@kumc.edu
-
-
Maryland
-
Baltimore, Maryland, United States, 21224
- Recruiting
- Johns Hopkins University of Medicine
-
Contact:
- Tiffany Loftus
- Email: ThoracicCancerTrials@jhmi.edu
-
-
Michigan
-
Detroit, Michigan, United States, 48201
- Recruiting
- Karmanos Cancer Institute
-
Contact:
- Tarik Hadid
- Phone Number: 1-800-537-6266
- Email: galassoc@karmanos.org
-
Detroit, Michigan, United States, 48202
- Recruiting
- Henry Ford Health
-
Contact:
- Dalia Abdullah
- Phone Number: 313 - 874-7518
- Email: dabdull3@hfhs.org
-
-
Missouri
-
St Louis, Missouri, United States, 63110
- Recruiting
- Washington University School of Medicine - Siteman Cancer Center
-
Contact:
- Phone Number: 314-747-1171
- Email: MedicalOncologyClinicalCallCenter@dom.wustl.edu
-
-
Montana
-
Billings, Montana, United States, 59102
- Recruiting
- St. Vincent Frontier Cancer Center
-
Contact:
- Heather Duyck
- Phone Number: (406) 238-6996
- Email: Heather.Duyck@imail.org
-
-
New Hampshire
-
Lebanon, New Hampshire, United States, 03756
- Recruiting
- Dartmouth-Hitchcock Medical Center
-
Contact:
-
-
New Jersey
-
Hackensack, New Jersey, United States, 07601
- Recruiting
- John Theurer Cancer Center At Hackensack UMC
-
Contact:
- Oncology Clinical Research Referral Office
- Phone Number: 551-996-1777
- Email: OncologyResearchReferral@hmhn.org
-
Morristown, New Jersey, United States, 07960
- Recruiting
- Morristown Medical Center (MMCORC)
-
Contact:
- Mary Phiakhamta
- Email: maimanivanh.phiakhamta@atlantichealth.org
-
-
New York
-
Buffalo, New York, United States, 14263
- Recruiting
- Roswell Park Cancer Institute
-
Contact:
- Edwin Yau
- Phone Number: 716-845-3099
- Email: Edwin.Yau@roswellpark.org
-
New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center
-
Contact:
- Kathryn Arbour
- Phone Number: 646-608-3792
- Email: arbourk@mskcc.org
-
The Bronx, New York, United States, 10461
- Recruiting
- Montefiore Medical Center
-
Contact:
- Yoko Eng
- Phone Number: 718-405-8516
- Email: YENG@montefiore.org
-
Contact:
- Charlotte Sklow
- Phone Number: 718-405-8535
- Email: charlotte.sklow@einsteinmed.edu
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- Recruiting
- UNC Lineberger Comprehensive Cancer Center at University of North Carolina
-
Contact:
- Mel Canter
- Phone Number: 1 (919) 962-0000
- Email: gmelahat@email.unc.edu
-
-
Ohio
-
Cincinnati, Ohio, United States, 45220
- Recruiting
- TriHealth Cancer & Blood Institute Research
-
Contact:
- Patrick Newbury
- Phone Number: 513-865-5249
- Email: Patrick_newbury@trihealth.com
-
Maumee, Ohio, United States, 43537
- Recruiting
- Taylor Cancer Research Center
-
Contact:
- Stephanie Ambrose
- Phone Number: 567-402-4500
- Email: sambrose@tcrcpt.org
-
-
Oregon
-
Eugene, Oregon, United States, 97401
- Recruiting
- Oncology Associates of Oregon PC
-
Contact:
- Jeanne Schaffer
- Phone Number: 541-683-5001
- Email: jeanne.schaffer@usoncology.com
-
-
Pennsylvania
-
Hershey, Pennsylvania, United States, 17033
- Recruiting
- Penn State Milton S. Hershey Medical Center
-
Contact:
- Takefumi Komiya
- Phone Number: 717-531-5471
- Email: PSCI-CTO@pennstatehealth.psu.edu
-
-
South Dakota
-
Aberdeen, South Dakota, United States, 57401
- Recruiting
- Avera Saint Luke's Hospital
-
Contact:
- Heidi Nickles
- Phone Number: 605-322-3295
- Email: MedoncResearch@avera.org
-
Sioux Falls, South Dakota, United States, 57105
- Recruiting
- Avera Cancer Institute
-
Contact:
- Heidi Nickles
- Phone Number: 605-322-3295
- Email: MedoncResearch@avera.org
-
-
Tennessee
-
Nashville, Tennessee, United States, 37203
- Recruiting
- SCRI Oncology Partners - Tennessee
-
Contact:
- Melissa Johnson, PI
- Phone Number: 844-482-4812
- Email: misty.moore@csri.com
-
-
Texas
-
Austin, Texas, United States, 78745
- Recruiting
- Texas Oncology - South Austin
-
Contact:
- Aide Borrego
- Phone Number: 512-447-2202
- Email: aide.borrego@usoncology.com
-
Dallas, Texas, United States, 75251
- Recruiting
- Texas Oncology Dallas
-
Contact:
- Christine Terraciano
- Phone Number: 214-370-1000
- Email: christine.terraciano@usoncology.com
-
Houston, Texas, United States, 77030
- Recruiting
- MD Anderson Cancer Center
-
Contact:
- Ferdinandos Skoulidis, MD
- Phone Number: 713-792-7734
- Email: FSkoulidis@mdanderson.org
-
The Woodlands, Texas, United States, 77380
- Recruiting
- Texas Oncology - Gulf Coast
-
Contact:
- Tara Gray
- Phone Number: (281) 316-4912
- Email: tara.gray@usoncology.com
-
Contact:
- Vanessa Johnson
- Phone Number: (281) 316-4912
- Email: vanessa.johnson@usoncology.com
-
-
Utah
-
Salt Lake City, Utah, United States, 84106
- Recruiting
- Utah Cancer Specialists
-
Contact:
- Stephan Kendall
- Phone Number: 801-281-6864
- Email: studies@utahcancer.com
-
Salt Lake City, Utah, United States, 84112
- Recruiting
- Huntsman Cancer Institute
-
Contact:
- Shantae George
- Phone Number: 801-213-8486
- Email: shantae.george@hci.utah.edu
-
-
Virginia
-
Fairfax, Virginia, United States, 22031
- Recruiting
- Virginia Cancer Specialists
-
Contact:
- Carrie Friedman
- Phone Number: 703-636-1473
- Email: Carrie.friedman@usoncology.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- At least 18 years old and has provided informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Pathologically confirmed NSCLC, either locally advanced or metastatic, not amenable to curative surgery or radiotherapy.
- Measurable disease per RECIST v1.1.
- Adequate organ function (bone marrow, liver, kidney, coagulation).
- One to two prior lines of therapy including an anti-PD-1/anti-PD(L)-1 agent and platinum-based chemotherapy.
- Documented RAS mutation status, defined as Nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61).
- Able to take oral medications.
Exclusion Criteria:
- Prior therapy with direct RAS-targeted therapy or docetaxel.
- Untreated central nervous system (CNS) metastases.
- Medically significant comorbidities (significant cardiovascular disease, lung disease, or impaired GI function).
- Ongoing anticancer therapy.
- Pregnant or breastfeeding.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: daraxonrasib
study drug
|
oral tablets
|
|
Active Comparator: docetaxel
Patients randomized to the comparator control arm will receive docetaxel as the standard of care therapy.
|
intravenous (IV) infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall survival (OS) in the RAS G12X-C population
Time Frame: Up to approximately 4 years
|
OS is defined as the time from randomization until death from any cause.
|
Up to approximately 4 years
|
|
Progression free survival (PFS) per Blinded Independent Central Review (BICR) in the RAS G12X-C population (i.e RAS G12X excluding G12C)
Time Frame: Up to approximately 4 years
|
PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first.
Progression is per response evaluation criteria in solid tumors (RECIST) v1.1 and as assessed by BICR.
|
Up to approximately 4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
OS in the RAS (MUT) population
Time Frame: up to approximately 4 years
|
OS is defined as time from randomization until death from any cause.
|
up to approximately 4 years
|
|
Time to response (TTR) per Investigator and per BICR in the RAS (G12X-C) and RAS (MUT) populations
Time Frame: Up to approximately 4 years
|
TTR is defined as time from randomization to first evidence of objective response (PR or CR), as assessed by Investigator and by BICR.
|
Up to approximately 4 years
|
|
Treatment effect on quality of life (QoL) using EORTC QLQ-LC13 In the RAS (G12X-C) and RAS (MUT) populations
Time Frame: Up to approximately 4 years
|
Time to deterioration (TTD) in selected symptoms (dyspnea, chest pain, cough) defined as the time from randomization to the first onset of 10 points or more deterioration from baseline in the corresponding symptom scales (dyspnea, chest pain, cough) on European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire LC-13 (EORTC QLQ-LC13). Change from baseline on EORTC QLQ-LC13 in symptom scales (dyspnea, cough, chest pain). |
Up to approximately 4 years
|
|
Treatment effect on quality of life (QoL) using EORTC QLQ-C30 In the RAS (G12X-C) and RAS (MUT) populations
Time Frame: Up to approximately 4 years
|
Change from baseline in global quality of life score from European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) questionnaire. Change from baseline on EORTC QLQ-C30 functioning domains (physical role, cognitive, emotional, social). |
Up to approximately 4 years
|
|
Safety and tolerability in the RAS (G12X-C) and RAS (MUT) population
Time Frame: Up to approximately 4 years
|
Incidence of treatment emergent adverse events (TEAEs), treatment related adverse events (TRAEs), serious adverse events (SAEs), changes in vital signs and clinical laboratory tests.
|
Up to approximately 4 years
|
|
PFS in the RAS (MUT) population per BICR
Time Frame: Up to approximately 4 years
|
PFS is defined as time from randomization until disease progression or death from any cause, whichever occurs first.
Progression is per RECIST v1.1 as assessed by BICR.
|
Up to approximately 4 years
|
|
Objective response per BICR in the RAS (G12X-C) and RAS (MUT) populations
Time Frame: Up to approximately 4 years
|
Objective response of partial response (PR) or complete response (CR) per RECIST v1.1 as assessed by BICR.
|
Up to approximately 4 years
|
|
PFS per Investigator in the RAS (G12X-C) and RAS (MUT) populations
Time Frame: Up to approximately 4 years
|
PFS is defined as time from randomization until disease progression or death from any cause, whichever occurs first.
Progression is per RECIST v1.1 as assessed by Investigator.
|
Up to approximately 4 years
|
|
Objective response per Investigator in the RAS (G12X-C) and RAS (MUT) populations
Time Frame: Up to approximately 4 years
|
Objective response of PR or CR per RECIST v1.1 as assessed by Investigator.
|
Up to approximately 4 years
|
|
Duration of response (DOR) per Investigator and per BICR in the RAS (G12X-C) and RAS (MUT) populations
Time Frame: Up to approximately 4 years
|
DOR is defined as time from first evidence of objective response (PR or CR) to disease progression or death due to any cause, whichever occurs first, as assessed by Investigator and by BICR.
|
Up to approximately 4 years
|
|
PK characterization of daraxonrasib In the RAS (MUT) population
Time Frame: Up to approximately 4 years
|
Predose and post-dose blood concentrations of daraxonrasib over time.
|
Up to approximately 4 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Respiratory Tract Diseases
- Lung Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Organic Chemicals
- Hydrocarbons
- Cycloparaffins
- Hydrocarbons, Alicyclic
- Hydrocarbons, Cyclic
- Terpenes
- Taxoids
- Cyclodecanes
- Diterpenes
- Docetaxel
Other Study ID Numbers
- RMC-6236-301
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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