Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
NCT ID: NCT06881784
Last Updated: 2025-12-24
Study Results
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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RECRUITING
PHASE3
420 participants
INTERVENTIONAL
2025-05-06
2030-12-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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docetaxel
Patients randomized to the comparator control arm will receive docetaxel as the standard of care therapy.
docetaxel
intravenous (IV) infusion
daraxonrasib
study drug
daraxonrasib
oral tablets
Interventions
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daraxonrasib
oral tablets
docetaxel
intravenous (IV) infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* Untreated central nervous system (CNS) metastases.
* Medically significant comorbidities (significant cardiovascular disease, lung disease, or impaired GI function).
* Ongoing anticancer therapy.
* Pregnant or breastfeeding.
18 Years
ALL
No
Sponsors
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Revolution Medicines, Inc.
INDUSTRY
Responsible Party
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Locations
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Alabama Oncology
Birmingham, Alabama, United States
MemorialCare Long Beach Medical Center
Long Beach, California, United States
Yale University, Smillow Cancer Center
New Haven, Connecticut, United States
Florida Cancer Specialists & Research Institute - South
Fort Myers, Florida, United States
BRCR Global
Plantation, Florida, United States
Cancer Care Centers of Breevard
Rockledge, Florida, United States
Florida Cancer Specialists & Research Institute - North
St. Petersburg, Florida, United States
Cleveland Clinic Martin North
Stuart, Florida, United States
Florida Cancer Specialists & Research Institute - East
West Palm Beach, Florida, United States
University Cancer and Blood Center
Athens, Georgia, United States
The University of Kansas Cancer Center
Westwood, Kansas, United States
Johns Hopkins University of Medicine
Baltimore, Maryland, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, United States
St. Vincent Frontier Cancer Center
Billings, Montana, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
UNC Lineberger Comprehensive Cancer Center at University of North Carolina
Chapel Hill, North Carolina, United States
TriHealth Cancer & Blood Institute Research
Cincinnati, Ohio, United States
Taylor Cancer Research Center
Maumee, Ohio, United States
Oncology Associates of Oregon PC
Eugene, Oregon, United States
SCRI Oncology Partners - Tennessee
Nashville, Tennessee, United States
Texas Oncology - South Austin
Austin, Texas, United States
Texas Oncology Dallas
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Texas Oncology - Gulf Coast
The Woodlands, Texas, United States
Utah Cancer Specialists
Salt Lake City, Utah, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Mater Misericordiae Limited
South Brisbane, Queensland, Australia
Grand Hôpital de Charleroi - Les Viviers
Gilly, , Belgium
AZ Groeninge
Kortrijk, , Belgium
AZ Delta
Roeselare, , Belgium
CHU Strasbourg - Nouvel Hôpital Civil
Strasbourg, Bas Rhin, France
Hopital Nord - CHU Marseille
Marseille, Bouches-du-Rhône, France
Institut régional du Cancer de Montpellier
Montpellier, Herault, France
CHU Rennes Hôpital Pontchaillou
Rennes, Ille et Vilaine, France
CHU de Grenoble - Hôpital Albert Michallon
La Tronche, Isere, France
CHU Nantes - Hôpital Guillaume et René Laënnec
Saint-Herblain, Loire Atlantique, France
Institut de Cancerologie de l Ouest
Saint-Herblain, Loire Atlantique, France
Centre Leon Berard
Léon, Lyon, France
Hopital Albert Calmette - CHU Lille
Lille, Nord, France
Hôpital Bichat - Claude Bernard
Paris, Paris, France
Hopital Louis Pradel
Bron, Rhone, France
Centre Hospitalier Intercommunal de Créteil
Créteil, Val de Marne, France
CHU Brest - Hôpital Morvan
Brest, , France
LKI Lungenfachklinik Immenhausen
Immenhausen, Hesse, Germany
Universitaetsklinikum Essen
Essen, North Rhine-Westphalia, Germany
Hong Kong United Oncology Centre
Hong Kong, , Hong Kong
Mater Private Hospital
Dublin, Dublin, Ireland
IEO Istituto Europeo di Oncologia
Milan, Milano, Italy
Azienda Socio Sanitaria Territoriale Niguarda
Milan, Milano, Italy
Istituto Clinico Humanitas
Rossano, Milano, Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, Napoli, Italy
Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)
Pisa, Pisa, Italy
Istituto Nazionale dei Tumori Regina Elena IRCCS
Roma, Roma, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, , Italy
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan
Fujita Health University Hospital
Toyoake-shi, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
NHO Shikoku Cancer Center
Matsuyama, Ehime, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan
Hyogo Cancer Center
Akashi, Hyōgo, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Nara Medical University Hospital
Kashihara-shi, Nara, Japan
Niigata Cancer Center
Niigata, Niigata, Japan
Kansai Medical University Hospital
Hirakata-shi, Osaka, Japan
Kindai University Hospital
Osakasayama-shi, Osaka, Japan
Shizuoka Cancer Center
Nagaizumi-chō, Shizuoka, Japan
National Cancer Center Hospital
Chuo Ku, Tokyo, Japan
Cancer Institute Hospital of JFCR
Koto-Ku, Tokyo, Japan
Wakayama Medical University Hospital
Wakayama, Wakayama, Japan
Amsterdam UMC, Locatie VUMC
Amsterdam, Netherlands, Netherlands
Erasmus Medisch Centrum
Rotterdam, Netherlands, Netherlands
Antoni van Leeuwenhoek
Amsterdam, , Netherlands
Maastricht University Medical Center P. Debyelaan 25
Maastricht, , Netherlands
Radboudumc
Nijmegen, , Netherlands
INSTYTUT GENETYKI I IMMMUNOLOGII GENIM sp. z o.o.
Lublin, , Poland
Med-Polonia Sp. z o.o.
Poznan, , Poland
Aidport Sp. z o.o.
Skorzewo, , Poland
Pan American Center for Oncology Trials
San Juan, Puerto Rico, Puerto Rico
National University Hospital
Singapore, Singapore, Singapore
National Cancer Centre Singapore
Singapore, , Singapore
Ajou University Hospital
Gyeonggi-do, Suwon-si, South Korea
Chungbuk National University Hospital
Cheongju-si, , South Korea
Chonnam National University Hwasun Hospital
Hwasun, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña, Spain
Hospital Universitari Dexeus
Barcelona, Barcelona, Spain
Hospital Universitario La Paz
Fuencarral-El Pardo, Madrid, Spain
Hospital Universitario HM Madrid Sanchinarro
Madrid, Madrid, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Universitätsspital Basel
Basel, , Switzerland
HFR Fribourg/Kantonsspital Fribourg
Fribourg, , Switzerland
Kantonsspital St. Gallen
Sankt Gallen, , Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan, Taiwan
Taipei Medical University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Stephanie (Sherbet) Abercrombie, CRC
Role: primary
Laura Macias
Role: primary
Jennifer Pope
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
Nikki Pope
Role: primary
Role: primary
Tiffany Loftus
Role: primary
Tarik Hadid
Role: primary
Role: primary
Heather Duyck
Role: primary
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
Bassel Ayoub
Role: primary
Role: backup
Christy VAN DER PERREN
Role: primary
Role: primary
Melissa Masschelin
Role: primary
Role: primary
Role: primary
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Role: primary
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Role: primary
Sandrine Hiret
Role: primary
Role: primary
Role: primary
Gérard Zalcman
Role: primary
Michael Duruisseaux
Role: primary
Role: primary
Role: primary
Role: primary
Martin Schuler
Role: primary
Role: primary
Role: primary
Antonio Passaro
Role: primary
Diego Signorelli
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Emilio Bria
Role: primary
Role: primary
Role: primary
Role: primary
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Role: primary
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Role: primary
Sayed Hashemi
Role: primary
Anne-Marie Dingemans
Role: primary
Adrianus de Langen
Role: primary
Lizza Hendricks
Role: primary
Role: primary
Role: primary
Rodryg Ramlau
Role: primary
Role: primary
Carlos Quijano
Role: primary
Haematology-Oncology Research Group (HORG)
Role: primary
National Cancer Centre Singapore
Role: primary
Hyun-Woo Lee
Role: primary
Ki Hyeong Lee
Role: primary
Young-Chul Kim
Role: primary
Hye Ryun Kim
Role: primary
Ana Carro Ramos
Role: primary
Roxana Reyes
Role: primary
Javier de Castro
Role: primary
Gema Garcia Ledo
Role: primary
Andres Barba Joaquin
Role: primary
Role: primary
Role: primary
Role: primary
Mei-Chun Lu
Role: primary
Yi-Ying Liu
Role: primary
Xiu-Juan Lin
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