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Looking for participantsPhase3

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

Sponsor: Revolution Medicines, Inc.

NCT ID: NCT06881784

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
daraxonrasib (drug), docetaxel (drug)
How long the study runs
Study runs about 67 months (dates as stated)
About the drug or intervention
daraxonrasib — drug: oral tablets · docetaxel — drug: intravenous (IV) infusion
Patient visit burden
Not specified by the sponsor

In plain English

This study is testing a drug called daraxonrasib (RMC-6236) in adults with non-small cell lung cancer (NSCLC) that has a change (mutation) in a gene called RAS. The cancer must be locally advanced or spread to other parts of the body and cannot be cured by surgery or radiotherapy.

Who can take part

  • Age 18 or over, and able to agree (give consent) to take part
  • Generally well and active, as measured by a performance score of 0 or 1
  • Diagnosed with non-small cell lung cancer (NSCLC) that is locally advanced or has spread, and cannot be cured with surgery or radiotherapy
  • Cancer that can be measured on scans
  • Healthy enough bone marrow, liver, kidneys and blood clotting
  • Have already had one or two courses of treatment, including immunotherapy (anti-PD-1 or anti-PD-L1 drugs) and platinum chemotherapy
  • Have test results showing a RAS gene mutation (in KRAS, NRAS or HRAS at certain spots called G12, G13 or Q61)
  • Able to swallow tablets

Who may not be able to

  • Have already had treatment that directly targets RAS, or a chemotherapy drug called docetaxel
  • Cancer that has spread to the brain or spinal cord and has not been treated
  • Other serious health problems, such as heart disease, lung disease or stomach/bowel problems
  • Still having other cancer treatment
  • Pregnant or breastfeeding

What taking part involves

  • • Taking an oral medicine (a tablet) called daraxonrasib (RMC-6236)
  • • Further details of the treatment plan are not stated — ask the trial team

Time commitment: Treatment involves taking tablets by mouth; details about how long the study lasts and how often visits happen are not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
590
Started
2025-05-06
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for nsclc (non-small cell lung cancer)
  • • Phase3 - 590 participants
  • • The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with nsclc (non-small cell lung cancer)

Where?

  • • London - Royal Marsden Hospital-London
  • • Liverpool - The Clatterbridge Cancer Centre
  • • Sutton - Royal Marsden Hospital-Sutton
  • • London - Royal Free Hospital
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

More detail

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.

NSCLC (Non-small Cell Lung Cancer)Non-Small Cell Lung CancerNSCLCNSCLC (Non-small Cell Lung Carcinoma)NSCLC (Advanced Non-small Cell Lung Cancer)

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

KRAS

What the study is looking for

  • ✓At least 18 years old and has provided agreement to take part.
  • ✓activity scale (ECOG) performance status of 0 or 1.
  • ✓Pathologically confirmed NSCLC, either that has grown locally or that has spread, not amenable to curative surgery or radiotherapy.
  • ✓cancer that can be measured on scans v1.1.
  • ✓healthy organ (bone marrow, liver, kidney, coagulation).

Who cannot take part

  • ✗Prior therapy with direct RAS-treatment that targets specific changes in the cancer or docetaxel.
  • ✗Untreated central nervous system (CNS) metastases.
  • ✗Medically significant other health conditions (significant cardiovascular disease, lung disease, or impaired GI function).
  • ✗Ongoing anticancer therapy.
  • ✗Pregnant or breastfeeding.
See the full criteria
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.

Where Is This Study? (5 UK sites)

Royal Marsden Hospital-London

London SW3 6JJ, United Kingdom

Recruiting
Site contact (verified)

The Clatterbridge Cancer Centre

Liverpool L7 8YA, United Kingdom

Recruiting
Site contact (verified)

Royal Marsden Hospital-Sutton

Sutton SM2 5PT, United Kingdom

Recruiting
Site contact (verified)

Royal Free Hospital

London W3 2QG, United Kingdom

Recruiting
Site contact (verified)
Ekaterini BoletiEkaterini.Boleti@nhs.net

The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Revolution Medicines Study Director

Sponsor contact

CONTACT

1-844-2-REVMED medinfo@revmed.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-07