Back to Trials
NCT06881784PHASE3Recruiting

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

Revolution Medicines, Inc.

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

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.

Interventions

DRUG

daraxonrasib

DRUG

docetaxel

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

NSCLC (Non-small Cell Lung Cancer)Non-Small Cell Lung CancerNSCLCNSCLC (Non-small Cell Lung Carcinoma)NSCLC (Advanced Non-small Cell Lung Cancer)

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