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

NCT ID: NCT06881784

Last Updated: 2026-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-06

Study Completion Date

2030-12-01

Brief Summary

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

Detailed Description

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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

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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)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

The central reader of the tumor scans will be masked to the patients' treatment arm.

Study Groups

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daraxonrasib

study drug

Group Type EXPERIMENTAL

daraxonrasib

Intervention Type DRUG

oral tablets

docetaxel

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

Group Type ACTIVE_COMPARATOR

docetaxel

Intervention Type DRUG

intravenous (IV) infusion

Interventions

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daraxonrasib

oral tablets

Intervention Type DRUG

docetaxel

intravenous (IV) infusion

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Revolution Medicines, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Alabama Oncology

Birmingham, Alabama, United States

Site Status RECRUITING

MemorialCare Long Beach Medical Center

Long Beach, California, United States

Site Status RECRUITING

Yale University, Smillow Cancer Center

New Haven, Connecticut, United States

Site Status RECRUITING

Florida Cancer Specialists & Research Institute - South

Fort Myers, Florida, United States

Site Status RECRUITING

BRCR Global

Plantation, Florida, United States

Site Status RECRUITING

Cancer Care Centers of Breevard

Rockledge, Florida, United States

Site Status RECRUITING

Florida Cancer Specialists & Research Institute - North

St. Petersburg, Florida, United States

Site Status RECRUITING

Cleveland Clinic Martin North

Stuart, Florida, United States

Site Status RECRUITING

Florida Cancer Specialists & Research Institute - East

West Palm Beach, Florida, United States

Site Status RECRUITING

University Cancer and Blood Center

Athens, Georgia, United States

Site Status RECRUITING

Center for Care and Discovery

Chicago, Illinois, United States

Site Status RECRUITING

The University of Kansas Cancer Center

Westwood, Kansas, United States

Site Status RECRUITING

Johns Hopkins University of Medicine

Baltimore, Maryland, United States

Site Status RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status RECRUITING

Henry Ford Health

Detroit, Michigan, United States

Site Status RECRUITING

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, United States

Site Status RECRUITING

St. Vincent Frontier Cancer Center

Billings, Montana, United States

Site Status RECRUITING

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status RECRUITING

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

Montefiore Medical Center

The Bronx, New York, United States

Site Status RECRUITING

UNC Lineberger Comprehensive Cancer Center at University of North Carolina

Chapel Hill, North Carolina, United States

Site Status RECRUITING

TriHealth Cancer & Blood Institute Research

Cincinnati, Ohio, United States

Site Status RECRUITING

Taylor Cancer Research Center

Maumee, Ohio, United States

Site Status RECRUITING

Oncology Associates of Oregon PC

Eugene, Oregon, United States

Site Status RECRUITING

SCRI Oncology Partners - Tennessee

Nashville, Tennessee, United States

Site Status RECRUITING

Texas Oncology - South Austin

Austin, Texas, United States

Site Status RECRUITING

Texas Oncology Dallas

Dallas, Texas, United States

Site Status RECRUITING

MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Texas Oncology - Gulf Coast

The Woodlands, Texas, United States

Site Status RECRUITING

Utah Cancer Specialists

Salt Lake City, Utah, United States

Site Status RECRUITING

Virginia Cancer Specialists

Fairfax, Virginia, United States

Site Status RECRUITING

Blacktown Medical Oncology Research

Blacktown, New South Wales, Australia

Site Status RECRUITING

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Site Status RECRUITING

Mater Misericordiae Limited

South Brisbane, Queensland, Australia

Site Status RECRUITING

Sir Charles Gairdner Hospital

Perth, Western Australia, Australia

Site Status RECRUITING

Institut Jules Bordet

Anderlecht, Belgium, Belgium

Site Status RECRUITING

Grand Hôpital de Charleroi - Les Viviers

Gilly, , Belgium

Site Status RECRUITING

AZ Groeninge

Kortrijk, , Belgium

Site Status RECRUITING

UZ Leuven-Campus Gasthuisberg

Leuven, , Belgium

Site Status RECRUITING

AZ Delta

Roeselare, , Belgium

Site Status RECRUITING

CHU Strasbourg - Nouvel Hôpital Civil

Strasbourg, Bas Rhin, France

Site Status RECRUITING

Hopital Nord - CHU Marseille

Marseille, Bouches-du-Rhône, France

Site Status RECRUITING

Institut régional du Cancer de Montpellier

Montpellier, Herault, France

Site Status RECRUITING

CHU Rennes Hôpital Pontchaillou

Rennes, Ille et Vilaine, France

Site Status RECRUITING

CHU de Grenoble - Hôpital Albert Michallon

La Tronche, Isere, France

Site Status RECRUITING

CHU Nantes - Hôpital Guillaume et René Laënnec

Saint-Herblain, Loire Atlantique, France

Site Status RECRUITING

Institut de Cancerologie de l Ouest

Saint-Herblain, Loire Atlantique, France

Site Status RECRUITING

Centre Leon Berard

Léon, Lyon, France

Site Status RECRUITING

Hopital Albert Calmette - CHU Lille

Lille, Nord, France

Site Status RECRUITING

Hôpital Bichat - Claude Bernard

Paris, Paris, France

Site Status RECRUITING

Hopital Louis Pradel

Bron, Rhone, France

Site Status RECRUITING

Centre Hospitalier Intercommunal de Créteil

Créteil, Val de Marne, France

Site Status RECRUITING

CHU Brest - Hôpital Morvan

Brest, , France

Site Status RECRUITING

LKI Lungenfachklinik Immenhausen

Immenhausen, Hesse, Germany

Site Status RECRUITING

Universitaetsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Site Status RECRUITING

Hong Kong United Oncology Centre

Hong Kong, , Hong Kong

Site Status RECRUITING

Mater Private Hospital

Dublin, Dublin, Ireland

Site Status RECRUITING

University Hospital Limerick

Cork, Limerick, Ireland

Site Status RECRUITING

IEO Istituto Europeo di Oncologia

Milan, Milano, Italy

Site Status RECRUITING

Azienda Socio Sanitaria Territoriale Niguarda

Milan, Milano, Italy

Site Status RECRUITING

Istituto Clinico Humanitas

Rossano, Milano, Italy

Site Status RECRUITING

Istituto Nazionale Tumori Fondazione G. Pascale

Napoli, Napoli, Italy

Site Status RECRUITING

Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)

Pisa, Pisa, Italy

Site Status RECRUITING

Istituto Nazionale dei Tumori Regina Elena IRCCS

Roma, Roma, Italy

Site Status RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, , Italy

Site Status RECRUITING

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, Japan

Site Status RECRUITING

Fujita Health University Hospital

Toyoake-shi, Aichi-ken, Japan

Site Status RECRUITING

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

Site Status RECRUITING

NHO Shikoku Cancer Center

Matsuyama, Ehime, Japan

Site Status RECRUITING

National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido, Japan

Site Status RECRUITING

Hyogo Cancer Center

Akashi, Hyōgo, Japan

Site Status RECRUITING

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

Site Status RECRUITING

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

Site Status RECRUITING

Tohoku University Hospital

Sendai, Miyagi, Japan

Site Status RECRUITING

Nara Medical University Hospital

Kashihara-shi, Nara, Japan

Site Status RECRUITING

Niigata Cancer Center

Niigata, Niigata, Japan

Site Status RECRUITING

Kansai Medical University Hospital

Hirakata-shi, Osaka, Japan

Site Status RECRUITING

Kindai University Hospital

Osakasayama-shi, Osaka, Japan

Site Status RECRUITING

Shizuoka Cancer Center

Nagaizumi-chō, Shizuoka, Japan

Site Status RECRUITING

National Cancer Center Hospital

Chuo Ku, Tokyo, Japan

Site Status RECRUITING

Cancer Institute Hospital of JFCR

Koto-Ku, Tokyo, Japan

Site Status RECRUITING

Wakayama Medical University Hospital

Wakayama, Wakayama, Japan

Site Status RECRUITING

Amsterdam UMC, Locatie VUMC

Amsterdam, Netherlands, Netherlands

Site Status RECRUITING

Erasmus Medisch Centrum

Rotterdam, Netherlands, Netherlands

Site Status RECRUITING

Antoni van Leeuwenhoek

Amsterdam, , Netherlands

Site Status RECRUITING

Maastricht University Medical Center P. Debyelaan 25

Maastricht, , Netherlands

Site Status RECRUITING

Radboudumc

Nijmegen, , Netherlands

Site Status RECRUITING

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

Lublin, , Poland

Site Status RECRUITING

Med-Polonia Sp. z o.o.

Poznan, , Poland

Site Status RECRUITING

Aidport Sp. z o.o.

Skorzewo, , Poland

Site Status RECRUITING

Pan American Center for Oncology Trials

San Juan, Puerto Rico, Puerto Rico

Site Status RECRUITING

National University Hospital

Singapore, Singapore, Singapore

Site Status RECRUITING

National Cancer Centre Singapore

Singapore, , Singapore

Site Status RECRUITING

Ajou University Hospital

Gyeonggi-do, Suwon-si, South Korea

Site Status RECRUITING

Chungbuk National University Hospital

Cheongju-si, , South Korea

Site Status RECRUITING

Chonnam National University Hwasun Hospital

Hwasun, , South Korea

Site Status RECRUITING

Korea University Anam Hospital

Seoul, , South Korea

Site Status RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status RECRUITING

Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Complejo Hospitalario Universitario A Coruña

A Coruña, A Coruña, Spain

Site Status RECRUITING

Hospital Universitari Dexeus

Barcelona, Barcelona, Spain

Site Status RECRUITING

Hospital Universitario La Paz

Fuencarral-El Pardo, Madrid, Spain

Site Status RECRUITING

Hospital Universitario HM Madrid Sanchinarro

Madrid, Madrid, Spain

Site Status RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status RECRUITING

Universitätsspital Basel

Basel, , Switzerland

Site Status RECRUITING

HFR Fribourg/Kantonsspital Fribourg

Fribourg, , Switzerland

Site Status RECRUITING

Kantonsspital St. Gallen

Sankt Gallen, , Switzerland

Site Status RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung, Taiwan, Taiwan

Site Status RECRUITING

National Cheng Kung University Hospital

Tainan, Taiwan, Taiwan

Site Status RECRUITING

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

Site Status RECRUITING

Taipei Medical University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Chang Gung Medical Foundation Linkou

Taoyuan District, , Taiwan

Site Status RECRUITING

Countries

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United States Australia Belgium France Germany Hong Kong Ireland Italy Japan Netherlands Poland Puerto Rico Singapore South Korea Spain Switzerland Taiwan

Central Contacts

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Revolution Medicines Study Director

Role: CONTACT

1-844-2-REVMED

Facility Contacts

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Stephanie (Sherbet) Abercrombie, CRC

Role: primary

205-803-4369

Laura Macias

Role: primary

562-706-2701

Jennifer Pope

Role: primary

(203) 494-3732

Martina Bedford

Role: primary

727-216-1143

Fabiany Chacin, CRC

Role: primary

+1 (561) 447-0614

Karla Childers

Role: primary

321-725-8300

Martina Bedford

Role: primary

239-274-9930

Angelic Gamez

Role: primary

772-419-2146

Martina Bedford

Role: primary

561-366-4100

Nikki Pope

Role: primary

706-353-5006

Role: primary

1-855-702-8222

Role: primary

913-945-7552

Tiffany Loftus

Role: primary

Tarik Hadid

Role: primary

1-800-537-6266

Dalia Abdullah

Role: primary

313 - 874-7518

Role: primary

314-747-1171

Heather Duyck

Role: primary

(406) 238-6996

Role: primary

Edwin Yau

Role: primary

716-845-3099

Kathryn Arbour

Role: primary

646-608-3792

Yoko Eng

Role: primary

718-405-8516

Charlotte Sklow

Role: backup

718-405-8535

Mel Canter

Role: primary

1 (919) 962-0000

Patrick Newbury

Role: primary

513-865-5249

Stephanie Ambrose

Role: primary

567-402-4500

Jeanne Schaffer

Role: primary

541-683-5001

Melissa Johnson, PI

Role: primary

844-482-4812

Aide Borrego

Role: primary

512-447-2202

Christine Terraciano

Role: primary

214-370-1000

Ferdinandos Skoulidis, MD

Role: primary

713-792-7734

Tara Gray

Role: primary

(281) 316-4912

Vanessa Johnson

Role: backup

(281) 316-4912

Stephan Kendall

Role: primary

801-281-6864

Carrie Friedman

Role: primary

703-636-1473

Genevieve Grant

Role: primary

+12 86705069

Kerrie Cornall

Role: primary

02 4014 3282

Bassel Ayoub

Role: primary

+61731631369

Role: backup

Kevin Jasas

Role: primary

08 6383 3185

Christelle Swidryk

Role: primary

+32 (0) 2 541 32 38

Christy VAN DER PERREN

Role: primary

Role: primary

Larissa Cumps

Role: primary

+32 (0)16 33 84 97

Melissa Masschelin

Role: primary

+32 (0)51 23 72 07

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Sandrine Hiret

Role: primary

+33240679705

Role: primary

Role: primary

Gérard Zalcman

Role: primary

+33 1 40 25 75 18

Michael Duruisseaux

Role: primary

+33478863780

Role: primary

Role: primary

Role: primary

Martin Schuler

Role: primary

+492017232000

Role: primary

+852 2386 8002

Role: primary

+35318858888

Grzegorz Korpanty

Role: primary

0035361482728

Antonio Passaro

Role: primary

+39257489482

Diego Signorelli

Role: primary

+39223903991

Role: primary

Role: primary

+398117770291

Role: primary

+3950996653

Role: primary

Emilio Bria

Role: primary

+39630154838

Role: primary

052-762-6111

Role: primary

0562-93-2111

Role: primary

04-7133-1111

Role: primary

089-999-1111

Role: primary

+81-11-811-9111

Role: primary

+81-78-929-1151

Role: primary

076-265-2000

Role: primary

045-520-2222

Role: primary

022-717-7000

Role: primary

0744-22-3051

Role: primary

025-266-5111

Role: primary

072-804-0101

Role: primary

072-366-0221

Role: primary

055-989-5222

Role: primary

+81-3-3542-2511

Role: primary

+81-3-3520-0111

Role: primary

073-447-2300

Sayed Hashemi

Role: primary

+31204444444

Anne-Marie Dingemans

Role: primary

+31433876543

Adrianus de Langen

Role: primary

31205127942

Lizza Hendricks

Role: primary

+31433875047

Chantal Smits Van der Graaf

Role: primary

Role: primary

Rodryg Ramlau

Role: primary

+48 513 155 613

Role: primary

Carlos Quijano

Role: primary

(787) 407-3333

Haematology-Oncology Research Group (HORG)

Role: primary

6908 2222

National Cancer Centre Singapore

Role: primary

+65-6436 8000

Hyun-Woo Lee

Role: primary

+82-31-219-5989

Ki Hyeong Lee

Role: primary

+82-43-269-6015

Young-Chul Kim

Role: primary

82-10-3635-2876

Yoon Ji Choi

Role: primary

+82-2-920-6267

Hye Ryun Kim

Role: primary

+82-2-2228-8125

Se-Hoon Lee

Role: primary

+82-2-3410-1132

Ana Carro Ramos

Role: primary

+34981178000 ext. x292414

Roxana Reyes

Role: primary

+34935460135

Javier de Castro

Role: primary

+34917277516

Gema Garcia Ledo

Role: primary

+34917567984

Andres Barba Joaquin

Role: primary

+34935565638

Role: primary

Role: primary

Role: primary

Mei-Chun Lu

Role: primary

+887-7-3121101 ext. 5664

Yi-Ying Liu

Role: primary

+887-6-2353535 ext. 3117

Xiu-Juan Lin

Role: primary

+886-2-2312-3456 ext. 268057

Chao-Hua Chiu (Lung Patients only)

Role: primary

886- 960303216

Ho-Wen Ko

Role: primary

886-9753-68089

Other Identifiers

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RMC-6236-301

Identifier Type: -

Identifier Source: org_study_id

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