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

NCT06881784 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: RMC-6236-301
• Study Type: interventional
• Target: 420
• Locations: 19 countries
• Sites: 129

Brief Summary

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

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)

Keywords

NSCLC; Non-Small Cell Lung Cancer; Lung Cancer; RAS; KRAS; HRAS; NRAS; RAS Q61 Mutation; RAS G12 Mutation; RAS G13 Mutation

Outcome Measures

Primary Outcomes (2)

• Progression free survival (PFS) per Investigator 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 Investigator.

  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.

  Up to approximately 4 years

Secondary Outcomes (11)

• PFS in the RAS (MUT) population per Investigator

  Up to approximately 4 years

• OS in the RAS (MUT) population

  up to approximately 4 years

• Objective response per Investigator in the RAS (G12X-C) and RAS (MUT) populations

  Up to approximately 4 years

• PFS per BICR in the RAS (G12X-C) and RAS (MUT) populations

  Up to approximately 4 years

• Objective response per BICR in the RAS (G12X-C) and RAS (MUT) populations

  Up to approximately 4 years

Study Arms (2)

daraxonrasib

EXPERIMENTAL

study drug

Drug: daraxonrasib

docetaxel

ACTIVE COMPARATOR

Patients randomized to the comparator control arm will receive docetaxel as the standard of care therapy.

Drug: docetaxel

Interventions

daraxonrasib DRUG

oral tablets

daraxonrasib

docetaxel DRUG

intravenous (IV) infusion

docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Revolution Medicines, Inc.: lead

Study Sites (129)

Alabama Oncology

Birmingham, Alabama, 35243, United States

RECRUITING

MemorialCare Long Beach Medical Center

Long Beach, California, 90806, United States

RECRUITING

Yale University, Smillow Cancer Center

New Haven, Connecticut, 06519, United States

RECRUITING

Florida Cancer Specialists & Research Institute - South

Fort Myers, Florida, 33901, United States

RECRUITING

BRCR Global

Plantation, Florida, 33322, United States

RECRUITING

Cancer Care Centers of Breevard

Rockledge, Florida, 32955, United States

RECRUITING

Florida Cancer Specialists & Research Institute - North

St. Petersburg, Florida, 33705, United States

RECRUITING

Cleveland Clinic Martin North

Stuart, Florida, 34994, United States

RECRUITING

Florida Cancer Specialists & Research Institute - East

West Palm Beach, Florida, 33401, United States

RECRUITING

University Cancer and Blood Center

Athens, Georgia, 30607, United States

RECRUITING

Center for Care and Discovery

Chicago, Illinois, 60637, United States

RECRUITING

The University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

RECRUITING

Johns Hopkins University of Medicine

Baltimore, Maryland, 21224, United States

RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

Henry Ford Health

Detroit, Michigan, 48202, United States

RECRUITING

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, 63110, United States

RECRUITING

St. Vincent Frontier Cancer Center

Billings, Montana, 59102, United States

RECRUITING

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

Morristown Medical Center (MMCORC)

Morristown, New Jersey, 07960, United States

RECRUITING

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10461, United States

RECRUITING

UNC Lineberger Comprehensive Cancer Center at University of North Carolina

Chapel Hill, North Carolina, 27599, United States

RECRUITING

TriHealth Cancer & Blood Institute Research

Cincinnati, Ohio, 45220, United States

RECRUITING

Taylor Cancer Research Center

Maumee, Ohio, 43537, United States

RECRUITING

Oncology Associates of Oregon PC

Eugene, Oregon, 97401, United States

RECRUITING

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

RECRUITING

SCRI Oncology Partners - Tennessee

Nashville, Tennessee, 37203, United States

RECRUITING

Texas Oncology - South Austin

Austin, Texas, 78745, United States

RECRUITING

Texas Oncology Dallas

Dallas, Texas, 75251, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Texas Oncology - Gulf Coast

The Woodlands, Texas, 77380, United States

RECRUITING

Utah Cancer Specialists

Salt Lake City, Utah, 84106, United States

RECRUITING

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

RECRUITING

Blacktown Medical Oncology Research

Blacktown, New South Wales, 2148, Australia

RECRUITING

Chris O'Brien Lifehouse

Camperdown, New South Wales, 2050, Australia

RECRUITING

Calvary Mater Newcastle

Waratah, New South Wales, 2298, Australia

RECRUITING

Mater Misericordiae Limited

South Brisbane, Queensland, 4101, Australia

RECRUITING

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

Sir Charles Gairdner Hospital

Perth, Western Australia, 6009, Australia

RECRUITING

Institut Jules Bordet

Anderlecht, Belgium, 1070, Belgium

RECRUITING

Grand Hôpital de Charleroi - Les Viviers

Gilly, 6060, Belgium

RECRUITING

AZ Groeninge

Kortrijk, 8500, Belgium

RECRUITING

UZ Leuven-Campus Gasthuisberg

Leuven, 3000, Belgium

RECRUITING

AZ Delta

Roeselare, 8800, Belgium

RECRUITING

CHU Strasbourg - Nouvel Hôpital Civil

Strasbourg, Bas Rhin, 67091, France

RECRUITING

Hopital Nord - CHU Marseille

Marseille, Bouches-du-Rhône, 13915, France

RECRUITING

Institut régional du Cancer de Montpellier

Montpellier, Herault, 34298, France

RECRUITING

CHU Rennes Hôpital Pontchaillou

Rennes, Ille et Vilaine, 35033, France

RECRUITING

CHU de Grenoble - Hôpital Albert Michallon

La Tronche, Isere, 38700, France

RECRUITING

CHU Nantes - Hôpital Guillaume et René Laënnec

Saint-Herblain, Loire Atlantique, 44805, France

RECRUITING

Institut de Cancerologie de l Ouest

Saint-Herblain, Loire Atlantique, 44805, France

RECRUITING

Centre Leon Berard

Léon, Lyon, 69008, France

RECRUITING

Hopital Albert Calmette - CHU Lille

Lille, Nord, 59037, France

RECRUITING

Hôpital Bichat - Claude Bernard

Paris, Paris, 75018, France

RECRUITING

Hopital Louis Pradel

Bron, Rhone, 69677, France

RECRUITING

Centre Hospitalier Intercommunal de Créteil

Créteil, Val de Marne, 94000, France

RECRUITING

Institut Gustave Roussy

Vaillant, Villejuif, 94800, France

RECRUITING

CHU Brest - Hôpital Morvan

Brest, 29200, France

RECRUITING

Institut Bergonie

Gironde, 33076, France

RECRUITING

CHU de Toulouse - Hopital Larrey

Toulouse, 31059, France

RECRUITING

LKI Lungenfachklinik Immenhausen

Immenhausen, Hesse, 34376, Germany

RECRUITING

Universitaetsklinikum Essen

Essen, North Rhine-Westphalia, 45147, Germany

RECRUITING

Universitaetsklinikum Carl Gustav Carus TU Dresden

Dresden, Saxony, 01307, Germany

RECRUITING

Thoraxklinik Heidelberg gGmbH

Baden, Wuerttemberg, 69469, Germany

RECRUITING

Klinikum Esslingen GmbH

Baden, 73730, Germany

RECRUITING

Evangelische Lungenklinik Berlin

Berlin, 13125, Germany

RECRUITING

Hong Kong United Oncology Centre

Hong Kong, Hong Kong

RECRUITING

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

Mater Private Hospital

Dublin, Dublin, 7, Ireland

RECRUITING

University Hospital Limerick

Cork, Limerick, V94 F858, Ireland

RECRUITING

Beaumont Hospital Cancer Clinical

Dublin, D09 V2N0, Ireland

RECRUITING

IEO Istituto Europeo di Oncologia

Milan, Milano, 20141, Italy

RECRUITING

Azienda Socio Sanitaria Territoriale Niguarda

Milan, Milano, 21206, Italy

RECRUITING

Istituto Clinico Humanitas

Rossano, Milano, 20089, Italy

RECRUITING

Fondazione IRCCS San Gerardo dei Tintori

Monza, Milan, 20900, Italy

RECRUITING

Istituto Nazionale Tumori Fondazione G. Pascale

Naples, Napoli, 80131, Italy

RECRUITING

Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)

Pisa, Pisa, 56124, Italy

RECRUITING

Istituto Nazionale dei Tumori Regina Elena IRCCS

Roma, Roma, 00144, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, 464-8681, Japan

RECRUITING

Fujita Health University Hospital

Toyoake-shi, Aichi-ken, 470-1192, Japan

RECRUITING

National Cancer Center Hospital East

Kashiwa-shi, Chiba, 277-8577, Japan

RECRUITING

NHO Shikoku Cancer Center

Matsuyama, Ehime, 791-0280, Japan

RECRUITING

National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido, 003-0804, Japan

RECRUITING

Hyogo Cancer Center

Akashi, Hyōgo, 673-8558, Japan

RECRUITING

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, 920-8641, Japan

RECRUITING

Kanagawa Cancer Center

Yokohama, Kanagawa, 241-8515, Japan

RECRUITING

Tohoku University Hospital

Sendai, Miyagi, 980-8574, Japan

RECRUITING

Nara Medical University Hospital

Kashihara-shi, Nara, 634-8522, Japan

RECRUITING

Niigata Cancer Center

Niigata, Niigata, 951-8566, Japan

RECRUITING

Kansai Medical University Hospital

Hirakata-shi, Osaka, 573-1191, Japan

RECRUITING

Kindai University Hospital

Osakasayama-shi, Osaka, 589-8511, Japan

RECRUITING

Shizuoka Cancer Center

Nagaizumi-chō, Shizuoka, 411-8777, Japan

RECRUITING

National Cancer Center Hospital

Chuo Ku, Tokyo, 104-0045, Japan

RECRUITING

Cancer Institute Hospital of JFCR

Koto-Ku, Tokyo, 135-8550, Japan

RECRUITING

Wakayama Medical University Hospital

Wakayama, Wakayama, 641-8510, Japan

RECRUITING

Amsterdam UMC, Locatie VUMC

Amsterdam, Netherlands, 1081BT, Netherlands

RECRUITING

Erasmus Medisch Centrum

Rotterdam, Netherlands, 3015AA, Netherlands

RECRUITING

Antoni van Leeuwenhoek

Amsterdam, 1066 CX, Netherlands

RECRUITING

Maastricht University Medical Center P. Debyelaan 25

Maastricht, 6229, Netherlands

RECRUITING

Radboudumc

Nijmegen, 6525 GA, Netherlands

RECRUITING

Auckland City Hospital - Cancer and Blood Research

Grafton, Auckland, 1023, New Zealand

RECRUITING

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

Lublin, 29-609, Poland

RECRUITING

Med-Polonia Sp. z o.o.

Poznan, 60-693, Poland

RECRUITING

Aidport Sp. z o.o.

Skorzewo, 60-185, Poland

RECRUITING

Pan American Center for Oncology Trials

San Juan, Puerto Rico, 00909, Puerto Rico

RECRUITING

National University Hospital

Singapore, Singapore, 119074, Singapore

RECRUITING

National Cancer Centre Singapore

Singapore, 168583, Singapore

RECRUITING

Ajou University Hospital

Gyeonggi-do, Suwon-si, 16499, South Korea

RECRUITING

Chungbuk National University Hospital

Cheongju-si, 28644, South Korea

RECRUITING

Chonnam National University Hwasun Hospital

Hwasun, 58128, South Korea

RECRUITING

Korea University Anam Hospital

Seoul, 02841, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Complejo Hospitalario Universitario A Coruña

A Coruña, A Coruña, 15006, Spain

RECRUITING

Hospital Universitari Dexeus

Barcelona, Barcelona, 08028, Spain

RECRUITING

Hospital Universitario La Paz

Fuencarral-El Pardo, Madrid, 28046, Spain

RECRUITING

Hospital Universitario HM Madrid Sanchinarro

Madrid, Madrid, 28050, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

RECRUITING

Universitätsspital Basel

Basel, 4031, Switzerland

RECRUITING

HFR Fribourg/Kantonsspital Fribourg

Fribourg, 1708, Switzerland

RECRUITING

Kantonsspital St. Gallen

Sankt Gallen, 9000, Switzerland

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung, Taiwan, 100, Taiwan

RECRUITING

National Cheng Kung University Hospital

Tainan, Taiwan, 704, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, Taiwan, 10002, Taiwan

RECRUITING

Taipei Medical University Hospital

Taipei, 110, Taiwan

RECRUITING

Chang Gung Medical Foundation Linkou

Taoyuan District, 333, Taiwan

RECRUITING

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

Revolution Medicines Study Director

CONTACT

1-844-2-REVMED; medinfo@revmed.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The central reader of the tumor scans will be masked to the patients' treatment arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 18, 2025
• Study Start: May 6, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2030
• Last Updated: March 12, 2026

Record last verified: 2025-11

Locations

IE (3); TW (5); GB (1); US (34); PR (1); DE (6); SG (2); ES (5); IT (8); JP (17); NL (5); PL (3); AU (6); KR (6); CH (3); FR (16); HK (2); BE (5); NZ (1)