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

NCT ID: NCT06881784

Last Updated: 2025-11-12

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)

Keywords

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

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

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

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

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

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

Grand Hôpital de Charleroi - Les Viviers

Gilly, , Belgium

Site Status RECRUITING

AZ Groeninge

Kortrijk, , 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

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

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

Hong Kong United Oncology Centre

Hong Kong, , Hong Kong

Site Status RECRUITING

Mater Private Hospital

Dublin, Dublin, Ireland

Site Status RECRUITING

Istituto Clinico Humanitas

Rossano, Milano, Italy

Site Status RECRUITING

Istituto Nazionale Tumori Fondazione G. Pascale

Napoli, Napoli, Italy

Site Status RECRUITING

Istituto Nazionale dei Tumori Regina Elena IRCCS

Roma, Roma, 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

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

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

Site Status RECRUITING

Nara Medical University Hospital

Kashihara-shi, Nara, Japan

Site Status RECRUITING

Niigata Cancer Center

Niigata, Niigata, 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

Antoni van Leeuwenhoek

Amsterdam, , Netherlands

Site Status RECRUITING

Radboudumc

Nijmegen, , Netherlands

Site Status RECRUITING

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

Lublin, , 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

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

Taipei Medical University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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

Central Contacts

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Revolution Medicines Study Director

Role: CONTACT

Phone: 1-844-2-REVMED

Email: [email protected]

Facility Contacts

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Stephanie (Sherbet) Abercrombie, CRC

Role: primary

Martina Bedford

Role: primary

Fabiany Chacin, CRC

Role: primary

Karla Childers

Role: primary

Martina Bedford

Role: primary

Angelic Gamez

Role: primary

Martina Bedford

Role: primary

Role: primary

Tiffany Loftus

Role: primary

Cathy Galaso

Role: primary

Sharon Prokop

Role: backup

Role: primary

Heather Duyck

Role: primary

Kathryn Arbour

Role: primary

Yoko Eng

Role: primary

Charlotte Sklow

Role: backup

Mel Canter

Role: primary

Patrick Newbury

Role: primary

Stephanie Ambrose

Role: primary

Jeanne Schaffer

Role: primary

Melissa Johnson, PI

Role: primary

Aide Borrego

Role: primary

Christine Terraciano

Role: primary

Ferdinandos Skoulidis, MD

Role: primary

Tara Gray

Role: primary

Vanessa Johnson

Role: backup

Stephan Kendall

Role: primary

Carrie Friedman

Role: primary

Christy VAN DER PERREN

Role: primary

Role: primary

Melissa Masschelin

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Gérard Zalcman

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

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Role: primary

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Role: primary

Adrianus de Langen

Role: primary

Role: primary

Role: primary

Role: primary

Carlos Quijano

Role: primary

Haematology-Oncology Research Group (HORG)

Role: primary

Role: primary

Role: primary

Role: primary

Mei-Chun Lu

Role: primary

Chao-Hua Chiu (Lung Patients only)

Role: primary

Other Identifiers

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RMC-6236-301

Identifier Type: -

Identifier Source: org_study_id