NSCLC (Non-small Cell Lung Cancer)Phase 3RASolve 301NCT06881784
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
A Phase 3 study testing daraxonrasib and docetaxel in people with NSCLC (Non-small Cell Lung Cancer) and Non-Small Cell Lung Cancer, run by Revolution Medicines, Inc. at 158 sites in 19 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC (Non-small Cell Lung Cancer), Non-Small Cell Lung Cancer, NSCLC
- What is being tested?
- daraxonrasib and docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 590 participants
- Where
- 158 sitesin 19 countries
- Study dates
- 6 May 2025to 1 Dec 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
158 sites in 19 countries. Contact the study team or a site near you to ask about taking part.
158 sites in 19 countries
United States45 sites, 45 recruiting
- Recruiting
Avera Saint Luke's Hospital
Aberdeen, South Dakota, 57401
Heidi Nickles, 605-322-3295, MedoncResearch@avera.org
- Recruiting
Trinity Health Ann Arbor Hospital
Ann Arbor, Michigan, 48106
Rose Juhasz, 734-712-7251, MCRCwebsitecontactform@trinity-health.org
- Recruiting
University Cancer and Blood Center
Athens, Georgia, 30607
Nikki Pope, 706-353-5006, research@universitycancer.com
- Recruiting
Piedmont Healthcare, Inc
Atlanta, Georgia, 30318
Karma McCants, 404-425-7938, karma.mccants@piedmont.org
- Recruiting
Winship Cancer Institute
Atlanta, Georgia, 30322
Ryan Hanula, 404-778-1900, ryan.justin.hanula@emory.edu
- Recruiting
Texas Oncology - South Austin
Austin, Texas, 78745
Aide Borrego, 512-447-2202, aide.borrego@usoncology.com
- Recruiting
Johns Hopkins University of Medicine
Baltimore, Maryland, 21224
Tiffany Loftus, ThoracicCancerTrials@jhmi.edu
- Recruiting
University of Iowa Health Care Cancer Services Quad Cities
Bettendorf, Iowa, 52722
William Zeitler, 319-356-1770, william-zeitler@uiowa.edu
- Recruiting
St. Vincent Frontier Cancer Center
Billings, Montana, 59102
Heather Duyck, (406) 238-6996, Heather.Duyck@imail.org
- Recruiting
Alabama Oncology
Birmingham, Alabama, 35243
Stephanie (Sherbet) Abercrombie, CRC, 205-803-4369, Stephanie.Abercrombie@alabamaoncology.com
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Edwin Yau, 716-845-3099, Edwin.Yau@roswellpark.org
- Recruiting
UNC Lineberger Comprehensive Cancer Center at University of North Carolina
Chapel Hill, North Carolina, 27599
Mel Canter, 1 (919) 962-0000, gmelahat@email.unc.edu
- Recruiting
University of Illinois Cancer Center
Chicago, Illinois, 60612
Meredith Russell, 312-355-5112, mrussel3@uic.edu
- Recruiting
Center for Care and Discovery
Chicago, Illinois, 60637
1-855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
- Recruiting
TriHealth Cancer & Blood Institute Research
Cincinnati, Ohio, 45220
Patrick Newbury, 513-865-5249, Patrick_newbury@trihealth.com
- Recruiting
Texas Oncology Dallas
Dallas, Texas, 75251
Christine Terraciano, 214-370-1000, christine.terraciano@usoncology.com
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
Tarik Hadid, 1-800-537-6266, galassoc@karmanos.org
- Recruiting
Henry Ford Health
Detroit, Michigan, 48202
Dalia Abdullah, 313 - 874-7518, dabdull3@hfhs.org
- Recruiting
Oncology Associates of Oregon PC
Eugene, Oregon, 97401
Jeanne Schaffer, 541-683-5001, jeanne.schaffer@usoncology.com
- Recruiting
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Carrie Friedman, 703-636-1473, Carrie.friedman@usoncology.com
- Recruiting
Florida Cancer Specialists & Research Institute - South
Fort Myers, Florida, 33901
Martina Bedford, 727-216-1143, ResearchProgramManagement@flcancer.com
- Recruiting
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, 07601
Oncology Clinical Research Referral Office, 551-996-1777, OncologyResearchReferral@hmhn.org
- Recruiting
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Takefumi Komiya, 717-531-5471, PSCI-CTO@pennstatehealth.psu.edu
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Ferdinandos Skoulidis, MD, 713-792-7734, FSkoulidis@mdanderson.org
- Recruiting
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
William Zeitler, 319-356-1770, william-zeitler@uiowa.edu
- Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
cancer.research.nurse@hitchcock.org
- Recruiting
MemorialCare Long Beach Medical Center
Long Beach, California, 90806
Laura Macias, 562-706-2701, LMacias@memorialcare.org
- Recruiting
Taylor Cancer Research Center
Maumee, Ohio, 43537
Stephanie Ambrose, 567-402-4500, sambrose@tcrcpt.org
- Recruiting
Morristown Medical Center (MMCORC)
Morristown, New Jersey, 07960
Mary Phiakhamta, maimanivanh.phiakhamta@atlantichealth.org
- Recruiting
SCRI Oncology Partners - Tennessee
Nashville, Tennessee, 37203
Melissa Johnson, PI, 844-482-4812, misty.moore@csri.com
- Recruiting
Yale University, Smillow Cancer Center
New Haven, Connecticut, 06519
Jennifer Pope, (203) 494-3732, jennifer.pope@yale.edu
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Kathryn Arbour, 646-608-3792, arbourk@mskcc.org
- Recruiting
BRCR Global
Plantation, Florida, 33322
Fabiany Chacin, CRC, +1 (561) 447-0614, fabianyc@brcrglobal.com
- Recruiting
Cancer Care Centers of Breevard
Rockledge, Florida, 32955
Karla Childers, 321-725-8300, karla.childers@usoncology.com
- Recruiting
Utah Cancer Specialists
Salt Lake City, Utah, 84106
Stephan Kendall, 801-281-6864, studies@utahcancer.com
- Recruiting
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Shantae George, 801-213-8486, shantae.george@hci.utah.edu
- Recruiting
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Heidi Nickles, 605-322-3295, MedoncResearch@avera.org
- Recruiting
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, 63110
314-747-1171, MedicalOncologyClinicalCallCenter@dom.wustl.edu
- Recruiting
Florida Cancer Specialists & Research Institute - North
St. Petersburg, Florida, 33705
Martina Bedford, 239-274-9930, ResearchProgramManagement@flcancer.com
- Recruiting
Cleveland Clinic Martin North
Stuart, Florida, 34994
Angelic Gamez, 772-419-2146, GamezA3@ccf.org
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10461
Yoko Eng, 718-405-8516, YENG@montefiore.org
Charlotte Sklow, 718-405-8535, charlotte.sklow@einsteinmed.edu
- Recruiting
Texas Oncology - Gulf Coast
The Woodlands, Texas, 77380
Tara Gray, (281) 316-4912, tara.gray@usoncology.com
Vanessa Johnson, (281) 316-4912, vanessa.johnson@usoncology.com
- Recruiting
University of Iowa Health Care, Mission Cancer + Blood
Waukee, Iowa, 50263
William Zeitler, 319-356-1770, william-zeitler@uiowa.edu
- Recruiting
Florida Cancer Specialists & Research Institute - East
West Palm Beach, Florida, 33401
Martina Bedford, 561-366-4100, ResearchProgramManagement@flcancer.com
- Recruiting
The University of Kansas Cancer Center
Westwood, Kansas, 66205
913-945-7552, CTNurseNav@kumc.edu
Japan22 sites, 22 recruiting
- Recruiting
Hyogo Cancer Center
Akashi, Hyōgo, 673-8558
+81-78-929-1151
- Recruiting
National Cancer Center Hospital
Chuo Ku, Tokyo, 104-0045
+81-3-3542-2511
- Recruiting
Saitama Medical University International Medical Center
Hidaka, Saitama, 350-1298
042-984-4111
- Recruiting
Kansai Medical University Hospital
Hirakata-shi, Osaka, 573-1191
072-804-0101
- Recruiting
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641
076-265-2000
- Recruiting
Nara Medical University Hospital
Kashihara-shi, Nara, 634-8522
0744-22-3051
- Recruiting
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577
04-7133-1111
- Recruiting
Cancer Institute Hospital of JFCR
Koto-Ku, Tokyo, 135-8550
+81-3-3520-0111
- Recruiting
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 602-8566
+81-75-251-5111
- Recruiting
NHO Himeji Medical Center
Matsuyama, Ehime, 791-0280
81 79-225-3211
- Recruiting
NHO Shikoku Cancer Center
Matsuyama, Ehime, 791-0280
089-999-1111
- Recruiting
Shizuoka Cancer Center
Nagaizumi-chō, Shizuoka, 411-8777
055-989-5222
- Recruiting
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 464-8681
052-762-6111
- Recruiting
Niigata Cancer Center
Niigata, Niigata, 951-8566
025-266-5111
- Recruiting
Kindai University Hospital
Osakasayama-shi, Osaka, 589-8511
072-366-0221
- Recruiting
Kitasato University Hospital
Sagamihara, Kanagawa, 252-0375
042-778-8111
- Recruiting
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804
+81-11-811-9111
- Recruiting
Tohoku University Hospital
Sendai, Miyagi, 980-8574
022-717-7000
- Recruiting
Sendai Kousei Hospital
Sendai, Miyagi, 981-0914
+81-22-728-8000
- Recruiting
Fujita Health University Hospital
Toyoake-shi, Aichi-ken, 470-1192
0562-93-2111
- Recruiting
Wakayama Medical University Hospital
Wakayama, Wakayama, 641-8510
073-447-2300
- Recruiting
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515
045-520-2222
France16 sites, 16 recruiting
- Recruiting
CHU Brest - Hôpital Morvan
Brest, 29200
gilles.quere@chu-brest.fr
Gilles Quere
- Recruiting
Hopital Louis Pradel
Bron, Rhone, 69677
Michael Duruisseaux, +33478863780, michael.duruisseaux@chu-lyon.fr
- Recruiting
Centre Hospitalier Intercommunal de Créteil
Créteil, Val de Marne, 94000
christos.chouaid@chicreteil.fr
Christos Chouaid
- Recruiting
Institut Bergonie
Gironde, 33076
Sophie Cousin, +33556333371, s.cousin@bordeaux.unicancer.fr
- Recruiting
CHU de Grenoble - Hôpital Albert Michallon
La Tronche, Isere, 38700
dmoro-sibilot@chu-grenoble.fr
Denis Moro-Sibilot
- Recruiting
Centre Leon Berard
Léon, Lyon, 69008
maurice.perol@lyon.unicancer.fr
Maurice Perol
- Recruiting
Hopital Albert Calmette - CHU Lille
Lille, Nord, 59037
alexis.cortot@chu-lille.fr
Alexis Cortot
- Recruiting
Hopital Nord - CHU Marseille
Marseille, Bouches-du-Rhône, 13915
pascale.tomasini@ap-hm.fr
Pascale Tomasini
- Recruiting
Institut régional du Cancer de Montpellier
Montpellier, Herault, 34298
quentin.thomas@icm.unicancer.fr
Thomas Quentin
- Recruiting
Hôpital Bichat - Claude Bernard
Paris, Paris, 75018
Gérard Zalcman, +33 1 40 25 75 18, gerard.zalcman@aphp.fr
- Recruiting
CHU Rennes Hôpital Pontchaillou
Rennes, Ille et Vilaine, 35033
herve.lena@chu-rennes.fr
Herva Lena
- Recruiting
CHU Nantes - Hôpital Guillaume et René Laënnec
Saint-Herblain, Loire Atlantique, 44805
elvire.pons@chu-nantes.fr
Elvire Pons-Tostivint
- Recruiting
Institut de Cancerologie de l Ouest
Saint-Herblain, Loire Atlantique, 44805
Sandrine Hiret, +33240679705, sandrine.hiret@ico.unicancer.fr
- Recruiting
CHU Strasbourg - Nouvel Hôpital Civil
Strasbourg, Bas Rhin, 67091
celine.mascaux@chru-strasbourg.fr
Celine Mascaux
- Recruiting
CHU de Toulouse - Hopital Larrey
Toulouse, 31059
Mazieres Julien, +33567771836, mazieres.j@chu-toulouse.fr
- Recruiting
Institut Gustave Roussy
Vaillant, Villejuif, 94800
Fabrice Barlesi, +33142114899, fabrice.barlesi@gustaveroussy.fr
Australia8 sites, 8 recruiting
- Recruiting
Blacktown Medical Oncology Research, Blacktown Hospital
Blacktown, New South Wales, 2148
Bo Gao, 02 9881 8000
- Recruiting
Blacktown Medical Oncology Research
Blacktown, New South Wales, 2148
Genevieve Grant, +12 86705069, genevieve.grant@health.nsw.gov.au
- Recruiting
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050
Maryam Correa, +61 2 8514 194, maryam.correa@ih.org
- Recruiting
St. George Private Hospital Clinical Trials Unit
Kogarah, New South Wales, 2217
Tracy Liaw, 02 8594 5785, liawt@ramsayhealth.com.au
- Recruiting
Alfred House
Melbourne, Victoria, 3004
Nova Chamen, 03 9076 9768, N.Chamen@alfred.org.au
- Recruiting
Sir Charles Gairdner Hospital
Perth, Western Australia, 6009
Kevin Jasas, 08 6383 3185, SCGH.MedOncCTM@health.wa.gov.au
- Recruiting
Mater Misericordiae Limited
South Brisbane, Queensland, 4101
Bassel Ayoub, +61731631369, Bassel.ayoub@mater.org.au
oncology.clinicaltrials@mater.org.au
- Recruiting
Calvary Mater Newcastle
Waratah, New South Wales, 2298
Kerrie Cornall, 02 4014 3282, Kerrie.Cornall@health.nsw.gov.au
Italy8 sites, 8 recruiting
- Recruiting
IEO Istituto Europeo di Oncologia
Milan, Milano, 20141
Antonio Passaro, +39257489482, antonio.passaro@ieo.it
- Recruiting
Azienda Socio Sanitaria Territoriale Niguarda
Milan, Milano, 21206
Diego Signorelli, +39223903991, diego.signorelli@ospedaleniguarda.it
- Recruiting
Fondazione IRCCS San Gerardo dei Tintori
Monza, Milan, 20900
Diego Luigi Cortinovis, diegoluigi.cortinovis@irccs-sa
- Recruiting
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, Napoli, 80131
+398117770291, a.morabito@istitutotumori.na.it
Alessandro Morabito
- Recruiting
Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)
Pisa, Pisa, 56124
+3950996653, iacopo.petrini@gmail.com
Iacopo Petrini
- Recruiting
Istituto Nazionale dei Tumori Regina Elena IRCCS
Roma, Roma, 00144
federico.cappuzzo@ifo.it
Federico Cappuzzo
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00168
Emilio Bria, +39630154838, emilio.bria@policlinicogemelli.it
- Recruiting
Istituto Clinico Humanitas
Rossano, Milano, 20089
luca.toschi@cancercenter.humanitas.it
Luca Toschi
Germany6 sites, 6 recruiting
- Recruiting
Thoraxklinik Heidelberg gGmbH
Baden, Wuerttemberg, 69469
Farastuk Bozorgmehr, +4962213968077, farastuk.bozorgmehr@med.uni-heidelberg.de
- Recruiting
Klinikum Esslingen GmbH
Baden, 73730
Faehling Martin, +4971131032402, m.faehling@klinikum-esslingen.de
- Recruiting
Evangelische Lungenklinik Berlin
Berlin, 13125
Grohe Christian, +493094802112, christian.grohe@jsd.de
- Recruiting
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, Saxony, 01307
Felix Saalfeld, +4935145811924, felix.saalfeld@ukdd.de
- Recruiting
Universitaetsklinikum Essen
Essen, North Rhine-Westphalia, 45147
Martin Schuler, +492017232000, martin.schuler@uk-essen.de
- Recruiting
LKI Lungenfachklinik Immenhausen
Immenhausen, Hesse, 34376
a.rittmeyer@lungenfachklinik-immenhausen.de
Achim Rittmeyer
Ireland6 sites, 6 recruiting
- Recruiting
Cork Univeristy Hospital
Cork, Cork, T12 DC4A
Hazel O'Sullivan, 021-4922687, hazel.osullivan@hse.ie
- Recruiting
University Hospital Limerick
Cork, Limerick, V94 F858
Grzegorz Korpanty, 0035361482728, greg.korpanty2@hse.ie
- Recruiting
Mater Private Hospital
Dublin, Dublin, 7
+35318858888, Jane.sui@materprivate.ie
Jane Sui
- Recruiting
Tallaght University Hospital
Dublin, 24
Sebastian Trainor, Sebastian.Trainor@tuh.ie
- Recruiting
Beaumont Hospital Cancer Clinical
Dublin, D09 V2N0
Jarushka Naidoo, +35318092010, jarushkanaidoo@beaumont.ie
- Recruiting
Galway University Hospital
Galway, H91 YR71
Silvie Blazkova, +353 91 524222, silvie.blazkova@hse.ie
South Korea6 sites, 6 recruiting
- Recruiting
Chungbuk National University Hospital
Cheongju-si, 28644
Ki Hyeong Lee, +82-43-269-6015, kihlee@chungbuk.ac.kr
- Recruiting
Ajou University Hospital
Gyeonggi-do, Suwon-si, 16499
Hyun-Woo Lee, +82-31-219-5989, hwlee71@gmail.com
- Recruiting
Chonnam National University Hwasun Hospital
Hwasun, 58128
Young-Chul Kim, 82-10-3635-2876, kyc0923@jnu.ac.kr
- Recruiting
Korea University Anam Hospital
Seoul, 02841
Yoon Ji Choi, +82-2-920-6267, yj_choi@korea.ac.kr
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
Hye Ryun Kim, +82-2-2228-8125, nobelg@yuhs.ac
- Recruiting
Samsung Medical Center
Seoul, 06351
Se-Hoon Lee, +82-2-3410-1132, sehoon.lee119@gmail.com
Belgium5 sites, 5 recruiting
- Recruiting
Institut Jules Bordet
Anderlecht, Belgium, 1070
Christelle Swidryk, +32 (0) 2 541 32 38, Christelle.swidryk@hubruxelles.be
- Recruiting
Grand Hôpital de Charleroi - Les Viviers
Gilly, 6060
Christy VAN DER PERREN, christy.vanderperren@ghdc.be
- Recruiting
AZ Groeninge
Kortrijk, 8500
sofie.derijcke@azgroeninge.be
Sofie Derijcke
- Recruiting
UZ Leuven-Campus Gasthuisberg
Leuven, 3000
Larissa Cumps, +32 (0)16 33 84 97, Larissa.cumps@uzleuven.be
- Recruiting
AZ Delta
Roeselare, 8800
Melissa Masschelin, +32 (0)51 23 72 07, melissa.masschelin@azdelta.be
Netherlands5 sites, 5 recruiting
- Recruiting
Amsterdam UMC, Locatie VUMC
Amsterdam, Netherlands, 1081BT
Sayed Hashemi, +31204444444
- Recruiting
Antoni van Leeuwenhoek
Amsterdam, 1066 CX
Adrianus de Langen, 31205127942
- Recruiting
Maastricht University Medical Center P. Debyelaan 25
Maastricht, 6229
Lizza Hendricks, +31433875047
- Recruiting
Radboudumc
Nijmegen, 6525 GA
Chantal Smits Van der Graaf, studies@hospital.nl
- Recruiting
Erasmus Medisch Centrum
Rotterdam, Netherlands, 3015AA
Anne-Marie Dingemans, +31433876543
Spain5 sites, 5 recruiting
- Recruiting
Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña, 15006
Ana Carro Ramos, +34981178000 ext. x292414, Ana.Carro.Ramos@sergas.es
- Recruiting
Hospital Universitari Dexeus
Barcelona, Barcelona, 08028
Roxana Reyes, +34935460135, rreyes@oncorosell.com
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Andres Barba Joaquin, +34935565638, abarba@santpau.cat
- Recruiting
Hospital Universitario La Paz
Fuencarral-El Pardo, Madrid, 28046
Javier de Castro, +34917277516, javier.decastro@salud.madrid.org
- Recruiting
Hospital Universitario HM Madrid Sanchinarro
Madrid, Madrid, 28050
Gema Garcia Ledo, +34917567984, gmgarcialedo@hmhospitales.com
Taiwan5 sites, 5 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, 100
Mei-Chun Lu, +887-7-3121101 ext. 5664, s951627@gmail.com
- Recruiting
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Yi-Ying Liu, betty22276@gmail.com
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 10002
Xiu-Juan Lin, +886-2-2312-3456 ext. 268057, linkiki@ntuh.gov.tw
- Recruiting
Taipei Medical University Hospital
Taipei, 110
Chao-Hua Chiu (Lung Patients only), 886- 960303216, chaohuachiu@gmail.com
- Recruiting
Chang Gung Medical Foundation Linkou
Taoyuan, 333
Ho-Wen Ko, 886-9753-68089, howwenko@gmail.com
United Kingdom5 sites, 5 recruiting
- Recruiting
The Clatterbridge Cancer Centre
Liverpool, Merseyside, L7 8YA
Carles Escriu, + 44 7887844080, carles.escriu@nhs.net
- Recruiting
Royal Marsden Hospital-London
London, Greater London, SW3 6JJ
Sanjay Popat, Lung.Trials@rmh.nhs.uk
- Recruiting
Royal Free Hospital
London, W3 2QG
Ekaterini Boleti, Ekaterini.Boleti@nhs.net
- Recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
Colin Lindsay, 441614468125, the-christie.LungResearchTeam@nhs.net
- Recruiting
Royal Marsden Hospital-Sutton
Sutton, Surrey, SM2 5PT
Sanjay Popat, Lung.Trials@rmh.nhs.uk
Hong Kong4 sites, 4 recruiting
- Recruiting
Hong Kong United Oncology Centre
Hong Kong
+852 2386 8002, Enquiry@hkuoc.hk
- Recruiting
Queen Mary Hospital
Hong Kong
Victor Lee, + 852 2255 4352, oncology@hku.hk
- Recruiting
Princess Margaret Hospital
Lai Chi Kok
Fiona Mei Ying Lim, 2990 2393
- Recruiting
The Chinese University of Hong Kong
Shatin, 00000
Molly LI, 35051042
Poland4 sites, 4 recruiting
- Recruiting
Klinika Onkologii I Radioterapii UCK
Gdansk, 80-214
Rafal Dziadziuszko, +48 58 584 45 71, rafald@gumed.edu.pl
- Recruiting
INSTYTUT GENETYKI I IMMMUNOLOGII GENIM sp. z o.o.
Lublin, 29-609
izachm@wp.pl
Izabela Chmielewska
- Recruiting
Med-Polonia Sp. z o.o.
Poznan, 60-693
Rodryg Ramlau, +48 513 155 613, rodrygramlau@gmail.com
- Recruiting
Aidport Sp. z o.o.
Skorzewo, 60-185
marcin.bednarek@aidport.pl
Marcin Bednarek
Singapore3 sites, 3 recruiting
- Recruiting
National University Hospital
Singapore, Singapore, 119074
Haematology-Oncology Research Group (HORG), 6908 2222, horg@nuhs.edu.sg
- Recruiting
National Cancer Centre Singapore
Singapore, 168583
National Cancer Centre Singapore, +65-6436 8000, clinical.trials@nccs.com.sg
- Recruiting
Icon Cancer Centre
Singapore, 574623
ICON Cancer Centre (Research Singapore Team), +65-66049919, researchsingapore@icon.team
Switzerland3 sites, 3 recruiting
- Recruiting
Universitätsspital Basel
Basel, 4031
benjamin.kasenda@usb.ch
Benjamin Kasenda
- Recruiting
HFR Fribourg/Kantonsspital Fribourg
Fribourg, 1708
alessandra.curioni-fontecedro@h-fr.ch
Alessandra Curioni-Fontecedro
- Recruiting
Kantonsspital St. Gallen
Sankt Gallen, 9000
martin.frueh@h-och.ch
Martin Frueh
New Zealand1 site, 1 recruiting
- Recruiting
Auckland City Hospital - Cancer and Blood Research
Grafton, Auckland, 1023
Merina Matthew, 093074949 ext. Ext 21650, merina.mathew@tewhatuora.govt.nz
Puerto Rico1 site, 1 recruiting
- Recruiting
Pan American Center for Oncology Trials
San Juan, Puerto Rico, 00909
Carlos Quijano, (787) 407-3333, info@panoncologytrials.com
About this study
Official title: 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
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.
Read the 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.
- Conditions
- NSCLC (Non-small Cell Lung Cancer), Non-Small Cell Lung Cancer, NSCLC, NSCLC (Non-small Cell Lung Carcinoma), NSCLC (Advanced Non-small Cell Lung Cancer)
- Being tested
- daraxonrasib, docetaxel
- Keywords
- NSCLC, Non-Small Cell Lung Cancer, Lung Cancer, RAS, KRAS, HRAS, NRAS, RAS Q61 Mutation, RAS G12 Mutation, RAS G13 Mutation
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
daraxonrasibDrug
oral tablets
docetaxelDrug
intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| daraxonrasib | Experimental | study drug Receives: Drug: daraxonrasib |
| docetaxel | Active comparator | Patients randomized to the comparator control arm will receive docetaxel as the standard of care therapy. Receives: Drug: docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS) per Blinded Independent Central Review (BICR) in the RAS G12X-C population (i.e RAS G12X excluding G12C)
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.
Measured: Up to approximately 4 years
Overall survival (OS) in the RAS G12X-C population
OS is defined as the time from randomization until death from any cause.
Measured: Up to approximately 4 years
Secondary outcomes (11)
PFS in the RAS (MUT) population per BICR
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.
Measured: Up to approximately 4 years
OS in the RAS (MUT) population
OS is defined as time from randomization until death from any cause.
Measured: up to approximately 4 years
Objective response per BICR in the RAS (G12X-C) and RAS (MUT) populations
Objective response of partial response (PR) or complete response (CR) per RECIST v1.1 as assessed by BICR.
Measured: Up to approximately 4 years
PFS per Investigator in the RAS (G12X-C) and RAS (MUT) populations
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.
Measured: Up to approximately 4 years
Objective response per Investigator in the RAS (G12X-C) and RAS (MUT) populations
Objective response of PR or CR per RECIST v1.1 as assessed by Investigator.
Measured: Up to approximately 4 years
Duration of response (DOR) per Investigator and per BICR in the RAS (G12X-C) and RAS (MUT) populations
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.
Measured: Up to approximately 4 years
Time to response (TTR) per Investigator and per BICR in the RAS (G12X-C) and RAS (MUT) populations
TTR is defined as time from randomization to first evidence of objective response (PR or CR), as assessed by Investigator and by BICR.
Measured: 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 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).
Measured: 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
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).
Measured: Up to approximately 4 years
Safety and tolerability in the RAS (G12X-C) and RAS (MUT) population
Incidence of treatment emergent adverse events (TEAEs), treatment related adverse events (TRAEs), serious adverse events (SAEs), changes in vital signs and clinical laboratory tests.
Measured: Up to approximately 4 years
PK characterization of daraxonrasib In the RAS (MUT) population
Predose and post-dose blood concentrations of daraxonrasib over time.
Measured: Up to approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start6 May 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Non-small Cell Lung Cancer)Studies of the same condition, open and under way.
- More trials run by Revolution Medicines, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 590 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Revolution Medicines, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881784
- Sponsor's protocol ID
- RMC-6236-301
- Acronym
- RASolve 301
- Status last verified
- Jul 2026
- First submitted
- 10 Mar 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No