Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)

Last updated: May 27, 2026
Sponsor: Revolution Medicines, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Non-small Cell Lung Cancer

Treatment

docetaxel

daraxonrasib

Clinical Study ID

NCT06881784
RMC-6236-301
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.

Eligibility Criteria

Inclusion

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 amenableto 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 andplatinum-based chemotherapy.

  • Documented RAS mutation status, defined as Nonsynonymous mutations in KRAS, NRAS, orHRAS at codons 12, 13, or 61 (G12, G13, or Q61).

  • Able to take oral medications.

Exclusion

Exclusion Criteria:

  • Prior therapy with direct RAS-targeted therapy or docetaxel.

  • Untreated central nervous system (CNS) metastases.

  • Medically significant comorbidities (significant cardiovascular disease, lungdisease, or impaired GI function).

  • Ongoing anticancer therapy.

  • Pregnant or breastfeeding.

Study Design

Total Participants: 590
Treatment Group(s): 2
Primary Treatment: docetaxel
Phase: 3
Study Start date:
May 06, 2025
Estimated Completion Date:
December 01, 2030

Study 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.

Connect with a study center

  • Blacktown Medical Oncology Research

    Blacktown, New South Wales 2148
    Australia

    Active - Recruiting

  • Blacktown Medical Oncology Research, Blacktown Hospital

    Blacktown, New South Wales 2148
    Australia

    Active - Recruiting

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales 2050
    Australia

    Active - Recruiting

  • St. George Private Hospital Clinical Trials Unit

    Kogarah, New South Wales 2217
    Australia

    Active - Recruiting

  • Calvary Mater Newcastle

    Waratah, New South Wales 2298
    Australia

    Active - Recruiting

  • Mater Misericordiae Limited

    South Brisbane, Queensland 4101
    Australia

    Active - Recruiting

  • Alfred House

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Sir Charles Gairdner Hospital

    Perth, Western Australia 6009
    Australia

    Active - Recruiting

  • Institut Jules Bordet

    Anderlecht, Belgium 1070
    Belgium

    Active - Recruiting

  • Grand Hôpital de Charleroi - Les Viviers

    Gilly, 6060
    Belgium

    Active - Recruiting

  • AZ Groeninge

    Kortrijk, 8500
    Belgium

    Active - Recruiting

  • UZ Leuven-Campus Gasthuisberg

    Leuven, 3000
    Belgium

    Active - Recruiting

  • AZ Delta

    Roeselare, 8800
    Belgium

    Active - Recruiting

  • CHU Strasbourg - Nouvel Hôpital Civil

    Strasbourg, Bas Rhin 67091
    France

    Active - Recruiting

  • Hopital Nord - CHU Marseille

    Marseille, Bouches-du-Rhône 13915
    France

    Active - Recruiting

  • Institut régional du Cancer de Montpellier

    Montpellier, Herault 34298
    France

    Active - Recruiting

  • CHU Rennes Hôpital Pontchaillou

    Rennes, Ille et Vilaine 35033
    France

    Active - Recruiting

  • CHU de Grenoble - Hôpital Albert Michallon

    La Tronche, Isere 38700
    France

    Active - Recruiting

  • CHU Nantes - Hôpital Guillaume et René Laënnec

    Saint-Herblain, Loire Atlantique 44805
    France

    Active - Recruiting

  • Institut de Cancerologie de l Ouest

    Saint-Herblain, Loire Atlantique 44805
    France

    Active - Recruiting

  • CHU Nantes - Hôpital Guillaume et René Laënnec

    Saint-Herblain 2979590, Loire Atlantique 44805
    France

    Active - Recruiting

  • Centre Leon Berard

    Léon, Lyon 69008
    France

    Active - Recruiting

  • Hopital Albert Calmette - CHU Lille

    Lille, Nord 59037
    France

    Active - Recruiting

  • Hôpital Bichat - Claude Bernard

    Paris, Paris 75018
    France

    Active - Recruiting

  • Hopital Louis Pradel

    Bron, Rhone 69677
    France

    Active - Recruiting

  • Centre Hospitalier Intercommunal de Créteil

    Créteil, Val de Marne 94000
    France

    Active - Recruiting

  • Institut Gustave Roussy

    Vaillant, Villejuif 94800
    France

    Active - Recruiting

  • CHU Brest - Hôpital Morvan

    Brest, 29200
    France

    Active - Recruiting

  • Institut Bergonie

    Gironde, 33076
    France

    Active - Recruiting

  • CHU de Toulouse - Hopital Larrey

    Toulouse, 31059
    France

    Active - Recruiting

  • LKI Lungenfachklinik Immenhausen

    Immenhausen, Hesse 34376
    Germany

    Active - Recruiting

  • Universitaetsklinikum Essen

    Essen, North Rhine-Westphalia 45147
    Germany

    Active - Recruiting

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, Saxony 01307
    Germany

    Active - Recruiting

  • Thoraxklinik Heidelberg gGmbH

    Baden, Wuerttemberg 69469
    Germany

    Active - Recruiting

  • Klinikum Esslingen GmbH

    Baden, 73730
    Germany

    Active - Recruiting

  • Evangelische Lungenklinik Berlin

    Berlin, 13125
    Germany

    Active - Recruiting

  • Hong Kong United Oncology Centre

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • Queen Mary Hospital

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • The Chinese University of Hong Kong

    Shatin, 00000
    Hong Kong

    Active - Recruiting

  • Cork Univeristy Hospital

    Cork, Cork T12 DC4A
    Ireland

    Active - Recruiting

  • Mater Private Hospital

    Dublin, Dublin 7
    Ireland

    Active - Recruiting

  • University Hospital Limerick

    Cork, Limerick V94 F858
    Ireland

    Active - Recruiting

  • Beaumont Hospital Cancer Clinical

    Dublin, D09 V2N0
    Ireland

    Active - Recruiting

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, Milan 20900
    Italy

    Active - Recruiting

  • Azienda Socio Sanitaria Territoriale Niguarda

    Milan, Milano 21206
    Italy

    Active - Recruiting

  • IEO Istituto Europeo di Oncologia

    Milan, Milano 20141
    Italy

    Active - Recruiting

  • IEO Istituto Europeo di Oncologia

    Milan 6951411, Milano 20141
    Italy

    Active - Recruiting

  • Istituto Clinico Humanitas

    Rossano, Milano 20089
    Italy

    Active - Recruiting

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Naples, Napoli 80131
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)

    Pisa, Pisa 56124
    Italy

    Active - Recruiting

  • Istituto Nazionale dei Tumori Regina Elena IRCCS

    Roma, Roma 00144
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, 00168
    Italy

    Active - Recruiting

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken 464-8681
    Japan

    Active - Recruiting

  • Fujita Health University Hospital

    Toyoake-shi, Aichi-ken 470-1192
    Japan

    Active - Recruiting

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba 277-8577
    Japan

    Active - Recruiting

  • NHO Himeji Medical Center

    Matsuyama, Ehime 791-0280
    Japan

    Active - Recruiting

  • NHO Shikoku Cancer Center

    Matsuyama, Ehime 791-0280
    Japan

    Active - Recruiting

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido 003-0804
    Japan

    Active - Recruiting

  • Hyogo Cancer Center

    Akashi, Hyōgo 673-8558
    Japan

    Active - Recruiting

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken 920-8641
    Japan

    Active - Recruiting

  • Kanagawa Cancer Center

    Yokohama, Kanagawa 241-8515
    Japan

    Active - Recruiting

  • Tohoku University Hospital

    Sendai, Miyagi 980-8574
    Japan

    Active - Recruiting

  • Nara Medical University Hospital

    Kashihara-shi, Nara 634-8522
    Japan

    Active - Recruiting

  • Niigata Cancer Center

    Niigata, Niigata 951-8566
    Japan

    Active - Recruiting

  • Kansai Medical University Hospital

    Hirakata-shi, Osaka 573-1191
    Japan

    Active - Recruiting

  • Kindai University Hospital

    Osakasayama-shi, Osaka 589-8511
    Japan

    Active - Recruiting

  • Shizuoka Cancer Center

    Nagaizumi-chō, Shizuoka 411-8777
    Japan

    Active - Recruiting

  • National Cancer Center Hospital

    Chuo Ku, Tokyo 104-0045
    Japan

    Active - Recruiting

  • Cancer Institute Hospital of JFCR

    Koto-Ku, Tokyo 135-8550
    Japan

    Active - Recruiting

  • Wakayama Medical University Hospital

    Wakayama, Wakayama 641-8510
    Japan

    Active - Recruiting

  • Amsterdam UMC, Locatie VUMC

    Amsterdam, Netherlands 1081BT
    Netherlands

    Active - Recruiting

  • Erasmus Medisch Centrum

    Rotterdam, Netherlands 3015AA
    Netherlands

    Active - Recruiting

  • Antoni van Leeuwenhoek

    Amsterdam, 1066 CX
    Netherlands

    Active - Recruiting

  • Antoni van Leeuwenhoek

    Amsterdam 2759794, 1066 CX
    Netherlands

    Active - Recruiting

  • Maastricht University Medical Center P. Debyelaan 25

    Maastricht, 6229
    Netherlands

    Active - Recruiting

  • Radboudumc

    Nijmegen, 6525 GA
    Netherlands

    Active - Recruiting

  • Auckland City Hospital - Cancer and Blood Research

    Grafton, Auckland 1023
    New Zealand

    Active - Recruiting

  • INSTYTUT GENETYKI I IMMMUNOLOGII GENIM sp. z o.o.

    Lublin, 29-609
    Poland

    Active - Recruiting

  • Med-Polonia Sp. z o.o.

    Poznan, 60-693
    Poland

    Active - Recruiting

  • Aidport Sp. z o.o.

    Skorzewo, 60-185
    Poland

    Active - Recruiting

  • Pan American Center for Oncology Trials

    San Juan, Puerto Rico 00909
    Puerto Rico

    Active - Recruiting

  • Pan American Center for Oncology Trials

    San Juan 4568127, 00909
    Puerto Rico

    Active - Recruiting

  • National University Hospital

    Singapore, Singapore 119074
    Singapore

    Active - Recruiting

  • National University Hospital

    Singapore 1880252, Singapore 119074
    Singapore

    Active - Recruiting

  • Icon Cancer Centre

    Singapore, 574623
    Singapore

    Active - Recruiting

  • National Cancer Centre Singapore

    Singapore, 168583
    Singapore

    Active - Recruiting

  • Ajou University Hospital

    Gyeonggi-do, Suwon-si 16499
    South Korea

    Active - Recruiting

  • Chungbuk National University Hospital

    Cheongju-si, 28644
    South Korea

    Active - Recruiting

  • Chonnam National University Hwasun Hospital

    Hwasun, 58128
    South Korea

    Active - Recruiting

  • Korea University Anam Hospital

    Seoul, 02841
    South Korea

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 06351
    South Korea

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    South Korea

    Active - Recruiting

  • Samsung Medical Center

    Seoul 1835848, 06351
    South Korea

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul 1835848, 03722
    South Korea

    Active - Recruiting

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, A Coruña 15006
    Spain

    Active - Recruiting

  • Hospital Universitari Dexeus

    Barcelona, Barcelona 08028
    Spain

    Active - Recruiting

  • Hospital Universitari Dexeus

    Barcelona 3128760, Barcelona 08028
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Fuencarral-El Pardo, Madrid 28046
    Spain

    Active - Recruiting

  • Hospital Universitario HM Madrid Sanchinarro

    Madrid, Madrid 28050
    Spain

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041
    Spain

    Active - Recruiting

  • Universitätsspital Basel

    Basel, 4031
    Switzerland

    Active - Recruiting

  • HFR Fribourg/Kantonsspital Fribourg

    Fribourg, 1708
    Switzerland

    Active - Recruiting

  • Kantonsspital St. Gallen

    Sankt Gallen, 9000
    Switzerland

    Active - Recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung, Taiwan 100
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital

    Tainan, Taiwan 704
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, Taiwan 10002
    Taiwan

    Active - Recruiting

  • Taipei Medical University Hospital

    Taipei, 110
    Taiwan

    Active - Recruiting

  • Taipei Medical University Hospital

    Taipei 1668341, 110
    Taiwan

    Active - Recruiting

  • Chang Gung Medical Foundation Linkou

    Taoyuan, 333
    Taiwan

    Active - Recruiting

  • Royal Marsden Hospital-London

    London, Greater London SW3 6JJ
    United Kingdom

    Active - Recruiting

  • The Clatterbridge Cancer Centre

    Liverpool, Merseyside L7 8YA
    United Kingdom

    Active - Recruiting

  • Royal Marsden Hospital-Sutton

    Sutton, Surrey SM2 5PT
    United Kingdom

    Active - Recruiting

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX
    United Kingdom

    Active - Recruiting

  • Alabama Oncology

    Birmingham, Alabama 35243
    United States

    Active - Recruiting

  • MemorialCare Long Beach Medical Center

    Long Beach, California 90806
    United States

    Active - Recruiting

  • Yale University, Smillow Cancer Center

    New Haven, Connecticut 06519
    United States

    Active - Recruiting

  • Florida Cancer Specialists & Research Institute - South

    Fort Myers, Florida 33901
    United States

    Active - Recruiting

  • BRCR Global

    Plantation, Florida 33322
    United States

    Active - Recruiting

  • Cancer Care Centers of Breevard

    Rockledge, Florida 32955
    United States

    Active - Recruiting

  • Florida Cancer Specialists & Research Institute - North

    St. Petersburg, Florida 33705
    United States

    Active - Recruiting

  • Cleveland Clinic Martin North

    Stuart, Florida 34994
    United States

    Active - Recruiting

  • Florida Cancer Specialists & Research Institute - East

    West Palm Beach, Florida 33401
    United States

    Active - Recruiting

  • University Cancer and Blood Center

    Athens, Georgia 30607
    United States

    Active - Recruiting

  • Piedmont Healthcare, Inc

    Atlanta, Georgia 30318
    United States

    Active - Recruiting

  • Center for Care and Discovery

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • The University of Kansas Cancer Center

    Westwood, Kansas 66205
    United States

    Active - Recruiting

  • Johns Hopkins University of Medicine

    Baltimore, Maryland 21224
    United States

    Active - Recruiting

  • Henry Ford Health

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Karmanos Cancer Institute

    Detroit 4990729, Michigan 5001836 48201
    United States

    Active - Recruiting

  • Washington University School of Medicine - Siteman Cancer Center

    St Louis, Missouri 63110
    United States

    Active - Recruiting

  • St. Vincent Frontier Cancer Center

    Billings, Montana 59102
    United States

    Active - Recruiting

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Active - Recruiting

  • John Theurer Cancer Center at Hackensack UMC

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Morristown Medical Center (MMCORC)

    Morristown, New Jersey 07960
    United States

    Active - Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York 14263
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Montefiore Medical Center

    The Bronx, New York 10461
    United States

    Active - Recruiting

  • UNC Lineberger Comprehensive Cancer Center at University of North Carolina

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

  • TriHealth Cancer & Blood Institute Research

    Cincinnati, Ohio 45220
    United States

    Active - Recruiting

  • Taylor Cancer Research Center

    Maumee, Ohio 43537
    United States

    Active - Recruiting

  • Oncology Associates of Oregon PC

    Eugene, Oregon 97401
    United States

    Active - Recruiting

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

  • Avera Saint Luke's Hospital

    Aberdeen, South Dakota 57401
    United States

    Active - Recruiting

  • Avera Cancer Institute

    Sioux Falls, South Dakota 57105
    United States

    Active - Recruiting

  • SCRI Oncology Partners - Tennessee

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Texas Oncology - South Austin

    Austin, Texas 78745
    United States

    Active - Recruiting

  • Texas Oncology Dallas

    Dallas, Texas 75251
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Texas Oncology - Gulf Coast

    The Woodlands, Texas 77380
    United States

    Active - Recruiting

  • Huntsman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

  • Utah Cancer Specialists

    Salt Lake City, Utah 84106
    United States

    Active - Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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