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

August 26, 2026 updated by: Revolution Medicines, Inc.

RASolve 301: Phase 3 Multicenter, Open Label, Randomized Study of RMC-6236 Versus Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic RAS[MUT] NSCLC

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

590

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Revolution Medicines Study Director
  • Phone Number: 1-844-2-REVMED
  • Email: medinfo@revmed.com

Study Locations

  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
      • Blacktown, New South Wales, Australia, 2148
        • Recruiting
        • Blacktown Medical Oncology Research, Blacktown Hospital
        • Contact:
          • Bo Gao
          • Phone Number: 02 9881 8000
      • Camperdown, New South Wales, Australia, 2050
        • Recruiting
        • Chris O'Brien Lifehouse
        • Contact:
      • Kogarah, New South Wales, Australia, 2217
        • Recruiting
        • St. George Private Hospital Clinical Trials Unit
        • Contact:
      • Waratah, New South Wales, Australia, 2298
    • Queensland
    • Victoria
      • Melbourne, Victoria, Australia, 3004
    • Western Australia
      • Perth, Western Australia, Australia, 6009
  • Belgium
      • Gilly, Belgium, 6060
      • Kortrijk, Belgium, 8500
      • Leuven, Belgium, 3000
        • Recruiting
        • UZ Leuven-Campus Gasthuisberg
        • Contact:
      • Roeselare, Belgium, 8800
    • Belgium
      • Anderlecht, Belgium, Belgium, 1070
  • France
      • Brest, France, 29200
      • Gironde, France, 33076
      • Toulouse, France, 31059
        • Recruiting
        • CHU de Toulouse - Hopital Larrey
        • Contact:
    • Bas Rhin
      • Strasbourg, Bas Rhin, France, 67091
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, France, 13915
    • Herault
      • Montpellier, Herault, France, 34298
    • Ille et Vilaine
      • Rennes, Ille et Vilaine, France, 35033
        • Recruiting
        • Chu Rennes Hopital Pontchaillou
        • Contact:
        • Principal Investigator:
          • Herva Lena
    • Isere
      • La Tronche, Isere, France, 38700
        • Recruiting
        • CHU de Grenoble - Hôpital Albert Michallon
        • Principal Investigator:
          • Denis Moro-Sibilot
        • Contact:
    • Loire Atlantique
      • Saint-Herblain, Loire Atlantique, France, 44805
        • Recruiting
        • CHU Nantes - Hôpital Guillaume et René Laënnec
        • Principal Investigator:
          • Elvire Pons-Tostivint
        • Contact:
      • Saint-Herblain, Loire Atlantique, France, 44805
    • Lyon
    • Nord
      • Lille, Nord, France, 59037
    • Paris
      • Paris, Paris, France, 75018
        • Recruiting
        • Hôpital Bichat - Claude Bernard
        • Contact:
    • Rhone
      • Bron, Rhone, France, 69677
    • Val de Marne
      • Créteil, Val de Marne, France, 94000
    • Villejuif
      • Vaillant, Villejuif, France, 94800
  • Germany
      • Baden, Germany, 73730
      • Berlin, Germany, 13125
        • Recruiting
        • Evangelische Lungenklinik Berlin
        • Contact:
    • Hesse
    • North Rhine-Westphalia
      • Essen, North Rhine-Westphalia, Germany, 45147
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Recruiting
        • Universitaetsklinikum Carl Gustav Carus TU Dresden
        • Contact:
    • Wuerttemberg
  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital
        • Contact:
      • Hong Kong, Hong Kong
        • Recruiting
        • Hong Kong United Oncology Centre
        • Contact:
      • Lai Chi Kok, Hong Kong
        • Recruiting
        • Princess Margaret Hospital
        • Contact:
          • Fiona Mei Ying Lim
          • Phone Number: 2990 2393
      • Shatin, Hong Kong, 00000
        • Recruiting
        • The Chinese University of Hong Kong
        • Contact:
          • Molly LI
          • Phone Number: 35051042
  • Ireland
      • Dublin, Ireland, D09 V2N0
        • Recruiting
        • Beaumont Hospital Cancer Clinical
        • Contact:
      • Dublin, Ireland, 24
      • Galway, Ireland, H91 YR71
        • Recruiting
        • Galway University Hospital
        • Contact:
    • Cork
      • Cork, Cork, Ireland, T12 DC4A
        • Recruiting
        • Cork Univeristy Hospital
        • Contact:
    • Dublin
      • Dublin, Dublin, Ireland, 7
        • Recruiting
        • Mater Private Hospital
        • Contact:
        • Principal Investigator:
          • Jane Sui
    • Limerick
      • Cork, Limerick, Ireland, V94 F858
        • Recruiting
        • University Hospital Limerick
        • Contact:
  • Italy
      • Rome, Italy, 00168
    • Milan
      • Monza, Milan, Italy, 20900
        • Recruiting
        • Fondazione IRCCS San Gerardo dei Tintori
        • Contact:
          • Diego Luigi Cortinovis
          • Phone Number: diegoluigi.cortinovis@irccs-sa
    • Milano
      • Milan, Milano, Italy, 20141
        • Recruiting
        • IEO Istituto Europeo di Oncologia
        • Contact:
      • Milan, Milano, Italy, 21206
      • Rossano, Milano, Italy, 20089
    • Napoli
      • Naples, Napoli, Italy, 80131
        • Recruiting
        • Istituto Nazionale Tumori Fondazione G. Pascale
        • Principal Investigator:
          • Alessandro Morabito
        • Contact:
    • Pisa
      • Pisa, Pisa, Italy, 56124
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)
        • Principal Investigator:
          • Iacopo Petrini
        • Contact:
    • Roma
      • Roma, Roma, Italy, 00144
        • Recruiting
        • Istituto Nazionale dei Tumori Regina Elena IRCCS
        • Principal Investigator:
          • Federico Cappuzzo
        • Contact:
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 464-8681
        • Recruiting
        • Aichi Cancer Center Hospital
        • Contact:
          • Phone Number: 052-762-6111
      • Toyoake-shi, Aichi-ken, Japan, 470-1192
        • Recruiting
        • Fujita Health University Hospital
        • Contact:
          • Phone Number: 0562-93-2111
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East
        • Contact:
          • Phone Number: 04-7133-1111
    • Ehime
      • Matsuyama, Ehime, Japan, 791-0280
        • Recruiting
        • NHO Shikoku Cancer Center
        • Contact:
          • Phone Number: 089-999-1111
      • Matsuyama, Ehime, Japan, 791-0280
        • Recruiting
        • NHO Himeji Medical Center
        • Contact:
          • Phone Number: 81 79-225-3211
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 003-0804
        • Recruiting
        • National Hospital Organization Hokkaido Cancer Center
        • Contact:
          • Phone Number: +81-11-811-9111
    • Hyōgo
      • Akashi, Hyōgo, Japan, 673-8558
        • Recruiting
        • Hyogo Cancer Center
        • Contact:
          • Phone Number: +81-78-929-1151
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8641
        • Recruiting
        • Kanazawa University Hospital
        • Contact:
          • Phone Number: 076-265-2000
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-8515
        • Recruiting
        • Kanagawa Cancer Center
        • Contact:
          • Phone Number: 045-520-2222
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Recruiting
        • Tohoku University Hospital
        • Contact:
          • Phone Number: 022-717-7000
      • Sendai, Miyagi, Japan, 981-0914
        • Recruiting
        • Sendai Kousei Hospital
        • Contact:
          • Phone Number: +81-22-728-8000
    • Nara
      • Kashihara-shi, Nara, Japan, 634-8522
        • Recruiting
        • Nara Medical University Hospital
        • Contact:
          • Phone Number: 0744-22-3051
    • Niigata
      • Niigata, Niigata, Japan, 951-8566
        • Recruiting
        • Niigata Cancer Center
        • Contact:
          • Phone Number: 025-266-5111
    • Osaka
      • Hirakata-shi, Osaka, Japan, 573-1191
        • Recruiting
        • Kansai Medical University Hospital
        • Contact:
          • Phone Number: 072-804-0101
      • Osakasayama-shi, Osaka, Japan, 589-8511
        • Recruiting
        • Kindai University Hospital
        • Contact:
          • Phone Number: 072-366-0221
    • Shizuoka
      • Nagaizumi-chō, Shizuoka, Japan, 411-8777
        • Recruiting
        • Shizuoka Cancer Center
        • Contact:
          • Phone Number: 055-989-5222
    • Tokyo
      • Chuo Ku, Tokyo, Japan, 104-0045
        • Recruiting
        • National Cancer Center Hospital
        • Contact:
          • Phone Number: +81-3-3542-2511
      • Koto-Ku, Tokyo, Japan, 135-8550
        • Recruiting
        • Cancer Institute Hospital of JFCR
        • Contact:
          • Phone Number: +81-3-3520-0111
    • Wakayama
      • Wakayama, Wakayama, Japan, 641-8510
        • Recruiting
        • Wakayama Medical University Hospital
        • Contact:
          • Phone Number: 073-447-2300
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Recruiting
        • Antoni van Leeuwenhoek
        • Contact:
          • Adrianus de Langen
          • Phone Number: 31205127942
      • Maastricht, Netherlands, 6229
        • Recruiting
        • Maastricht University Medical Center P. Debyelaan 25
        • Contact:
          • Lizza Hendricks
          • Phone Number: +31433875047
      • Nijmegen, Netherlands, 6525 GA
    • Netherlands
      • Amsterdam, Netherlands, Netherlands, 1081BT
        • Recruiting
        • Amsterdam UMC, Locatie VUMC
        • Contact:
          • Sayed Hashemi
          • Phone Number: +31204444444
      • Rotterdam, Netherlands, Netherlands, 3015AA
        • Recruiting
        • Erasmus Medisch Centrum
        • Contact:
          • Anne-Marie Dingemans
          • Phone Number: +31433876543
  • New Zealand
    • Auckland
      • Grafton, Auckland, New Zealand, 1023
        • Recruiting
        • Auckland City Hospital - Cancer and Blood Research
        • Contact:
  • Poland
      • Gdansk, Poland, 80-214
        • Recruiting
        • Klinika Onkologii I Radioterapii UCK
        • Contact:
      • Lublin, Poland, 29-609
        • Recruiting
        • INSTYTUT GENETYKI I IMMMUNOLOGII GENIM sp. z o.o.
        • Principal Investigator:
          • Izabela Chmielewska
        • Contact:
      • Poznan, Poland, 60-693
        • Recruiting
        • Med-Polonia Sp. z o.o.
        • Contact:
      • Skorzewo, Poland, 60-185
  • Puerto Rico
    • Puerto Rico
      • San Juan, Puerto Rico, Puerto Rico, 00909
        • Recruiting
        • Pan American Center for Oncology Trials
        • Contact:
  • Singapore
      • Singapore, Singapore, 168583
        • Recruiting
        • National Cancer Centre Singapore
        • Contact:
      • Singapore, Singapore, 574623
        • Recruiting
        • ICON Cancer Centre
        • Contact:
    • Singapore
      • Singapore, Singapore, Singapore, 119074
        • Recruiting
        • National University Hospital
        • Contact:
          • Haematology-Oncology Research Group (HORG)
          • Phone Number: 6908 2222
          • Email: horg@nuhs.edu.sg
  • South Korea
      • Cheongju-si, South Korea, 28644
        • Recruiting
        • Chungbuk National University Hospital
        • Contact:
      • Hwasun, South Korea, 58128
        • Recruiting
        • Chonnam National University Hwasun Hospital
        • Contact:
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System
        • Contact:
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
        • Contact:
      • Seoul, South Korea, 02841
        • Recruiting
        • Korea University Anam Hospital
        • Contact:
    • Suwon-si
      • Gyeonggi-do, Suwon-si, South Korea, 16499
        • Recruiting
        • Ajou University Hospital
        • Contact:
  • Spain
      • Barcelona, Spain, 08041
        • Recruiting
        • Hospital de La Santa Creu I Sant Pau
        • Contact:
    • A Coruña
      • A Coruña, A Coruña, Spain, 15006
        • Recruiting
        • Complejo Hospitalario Universitario A Coruna
        • Contact:
    • Barcelona
      • Barcelona, Barcelona, Spain, 08028
        • Recruiting
        • Hospital Universitari Dexeus
        • Contact:
    • Madrid
      • Fuencarral-El Pardo, Madrid, Spain, 28046
      • Madrid, Madrid, Spain, 28050
        • Recruiting
        • Hospital Universitario HM Madrid Sanchinarro
        • Contact:
  • Switzerland
      • Basel, Switzerland, 4031
        • Recruiting
        • Universitatsspital Basel
        • Principal Investigator:
          • Benjamin Kasenda
        • Contact:
      • Fribourg, Switzerland, 1708
      • Sankt Gallen, Switzerland, 9000
        • Recruiting
        • Kantonsspital St. Gallen
        • Contact:
        • Principal Investigator:
          • Martin Frueh
  • Taiwan
      • Taipei, Taiwan, 110
        • Recruiting
        • Taipei Medical University Hospital
        • Contact:
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung Medical Foundation Linkou
        • Contact:
    • Taiwan
      • Kaohsiung, Taiwan, Taiwan, 100
        • Recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Contact:
      • Tainan, Taiwan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital
        • Contact:
      • Taipei, Taiwan, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
  • United Kingdom
    • Greater London
      • London, Greater London, United Kingdom, SW3 6JJ
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L7 8YA
        • Recruiting
        • The Clatterbridge Cancer Centre
        • Contact:
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
  • United States
    • Alabama
    • California
      • Long Beach, California, United States, 90806
        • Recruiting
        • MemorialCare Long Beach Medical Center
        • Contact:
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Recruiting
        • Yale University, Smillow Cancer Center
        • Contact:
    • Florida
      • Fort Myers, Florida, United States, 33901
      • Plantation, Florida, United States, 33322
        • Recruiting
        • BRCR Global
        • Contact:
      • Rockledge, Florida, United States, 32955
      • St. Petersburg, Florida, United States, 33705
      • Stuart, Florida, United States, 34994
        • Recruiting
        • Cleveland Clinic Martin North
        • Contact:
      • West Palm Beach, Florida, United States, 33401
    • Georgia
      • Athens, Georgia, United States, 30607
      • Atlanta, Georgia, United States, 30322
      • Atlanta, Georgia, United States, 30318
    • Illinois
    • Iowa
      • Bettendorf, Iowa, United States, 52722
        • Recruiting
        • University of Iowa Health Care Cancer Services Quad Cities
        • Contact:
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Hospitals & Clinics
        • Contact:
      • Waukee, Iowa, United States, 50263
        • Recruiting
        • University of Iowa Health Care, Mission Cancer + Blood
        • Contact:
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • The University of Kansas Cancer Center
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21224
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Karmanos Cancer Institute
        • Contact:
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health
        • Contact:
    • Missouri
    • Montana
      • Billings, Montana, United States, 59102
        • Recruiting
        • St. Vincent Frontier Cancer Center
        • Contact:
    • New Hampshire
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • John Theurer Cancer Center at Hackensack UMC
        • Contact:
      • Morristown, New Jersey, United States, 07960
    • New York
      • Buffalo, New York, United States, 14263
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
      • The Bronx, New York, United States, 10461
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • UNC Lineberger Comprehensive Cancer Center at University of North Carolina
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Recruiting
        • TriHealth Cancer & Blood Institute Research
        • Contact:
      • Maumee, Ohio, United States, 43537
        • Recruiting
        • Taylor Cancer Research Center
        • Contact:
    • Oregon
      • Eugene, Oregon, United States, 97401
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
    • South Dakota
      • Aberdeen, South Dakota, United States, 57401
        • Recruiting
        • Avera Saint Luke's Hospital
        • Contact:
      • Sioux Falls, South Dakota, United States, 57105
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • SCRI Oncology Partners - Tennessee
        • Contact:
    • Texas
      • Austin, Texas, United States, 78745
      • Dallas, Texas, United States, 75251
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Contact:
      • The Woodlands, Texas, United States, 77380
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Recruiting
        • Utah Cancer Specialists
        • Contact:
      • Salt Lake City, Utah, United States, 84112
    • Virginia
      • Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: daraxonrasib
study drug
Drug: daraxonrasib
oral tablets
Active Comparator: docetaxel
Patients randomized to the comparator control arm will receive docetaxel as the standard of care therapy.
Drug: docetaxel
intravenous (IV) infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS) in the RAS G12X-C population
Time Frame: Up to approximately 4 years
OS is defined as the time from randomization until death from any cause.
Up to approximately 4 years
Progression free survival (PFS) per Blinded Independent Central Review (BICR) in the RAS G12X-C population (i.e RAS G12X excluding G12C)
Time Frame: Up to approximately 4 years
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 BICR.
Up to approximately 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS in the RAS (MUT) population
Time Frame: up to approximately 4 years
OS is defined as time from randomization until death from any cause.
up to approximately 4 years
Time to response (TTR) per Investigator and per BICR in the RAS (G12X-C) and RAS (MUT) populations
Time Frame: Up to approximately 4 years
TTR is defined as time from randomization to first evidence of objective response (PR or CR), as assessed by Investigator and by BICR.
Up to approximately 4 years
Treatment effect on quality of life (QoL) using EORTC QLQ-LC13 In the RAS (G12X-C) and RAS (MUT) populations
Time Frame: Up to approximately 4 years

Time to deterioration (TTD) in selected symptoms (dyspnea, chest pain, cough) defined as the time from randomization to the first onset of 10 points or more deterioration from baseline in the corresponding symptom scales (dyspnea, chest pain, cough) on European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire LC-13 (EORTC QLQ-LC13).

Change from baseline on EORTC QLQ-LC13 in symptom scales (dyspnea, cough, chest pain).
Up to approximately 4 years
Treatment effect on quality of life (QoL) using EORTC QLQ-C30 In the RAS (G12X-C) and RAS (MUT) populations
Time Frame: Up to approximately 4 years

Change from baseline in global quality of life score from European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) questionnaire.

Change from baseline on EORTC QLQ-C30 functioning domains (physical role, cognitive, emotional, social).
Up to approximately 4 years
Safety and tolerability in the RAS (G12X-C) and RAS (MUT) population
Time Frame: Up to approximately 4 years
Incidence of treatment emergent adverse events (TEAEs), treatment related adverse events (TRAEs), serious adverse events (SAEs), changes in vital signs and clinical laboratory tests.
Up to approximately 4 years
PFS in the RAS (MUT) population per BICR
Time Frame: Up to approximately 4 years
PFS is defined as time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per RECIST v1.1 as assessed by BICR.
Up to approximately 4 years
Objective response per BICR in the RAS (G12X-C) and RAS (MUT) populations
Time Frame: Up to approximately 4 years
Objective response of partial response (PR) or complete response (CR) per RECIST v1.1 as assessed by BICR.
Up to approximately 4 years
PFS per Investigator in the RAS (G12X-C) and RAS (MUT) populations
Time Frame: Up to approximately 4 years
PFS is defined as time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per RECIST v1.1 as assessed by Investigator.
Up to approximately 4 years
Objective response per Investigator in the RAS (G12X-C) and RAS (MUT) populations
Time Frame: Up to approximately 4 years
Objective response of PR or CR per RECIST v1.1 as assessed by Investigator.
Up to approximately 4 years
Duration of response (DOR) per Investigator and per BICR in the RAS (G12X-C) and RAS (MUT) populations
Time Frame: Up to approximately 4 years
DOR is defined as time from first evidence of objective response (PR or CR) to disease progression or death due to any cause, whichever occurs first, as assessed by Investigator and by BICR.
Up to approximately 4 years
PK characterization of daraxonrasib In the RAS (MUT) population
Time Frame: Up to approximately 4 years
Predose and post-dose blood concentrations of daraxonrasib over time.
Up to approximately 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Revolution Medicines, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 18, 2025

Study Record Updates

Last Update Posted (Actual)

August 27, 2026

Last Update Submitted That Met QC Criteria

August 26, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMC-6236-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe