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Taking people in ItalyPhase 3

Tests daraxonrasib against docetaxel in previously treated lung cancer with RAS mutations

Compares daraxonrasib with docetaxel in adults with previously treated RAS-mutated lung cancer.

Key facts

Who runs it
Revolution Medicines, Inc.
Where
Milan, Monza, Naples, Orbassano, Parma, Perugia, Pisa, Rome, Rozzano, and Verona, ItalySee the 16 sitesAlso in 18 other countries, 185 sites
Registry title
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
Status
Recruiting
Phase
Phase 3
People taking part
590 people, planned
Started
6 May 2025
Expected to end
1 Dec 2030
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • daraxonrasib
  • docetaxel
Record updated
6 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced or metastatic non-small cell lung cancer that has a RAS gene change and has already been treated. It compares the study drug daraxonrasib with docetaxel.

Age
18 years or older
Sex
All sexes can join
Disease stage
Non-small cell lung cancer that is locally advanced or has spread, and cannot be treated with surgery or radiotherapy meant to remove all of the disease. The disease must be measurable on scans (RECIST v1.1).
Earlier treatment
1 to 2 earlier lines of treatment, including an anti-PD-1/anti-PD(L)-1 drug and platinum-based chemotherapy. No earlier RAS-targeted therapy or docetaxel.
Biomarker or test result
A documented RAS mutation: a change in KRAS, NRAS or HRAS at codon 12, 13 or 61 (G12, G13 or Q61).

Main reasons for not taking part

  • Earlier treatment with a direct RAS-targeted drug or docetaxel
  • Brain or spinal cord metastases that have not been treated
  • Serious heart, lung or gut problems
  • Anticancer treatment that is still ongoing
  • Pregnant or breastfeeding

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Prior therapy with direct RAS-targeted therapy or docetaxel
  • Ongoing anticancer therapy
  • Medically significant comorbidities (significant cardiovascular disease, lung disease, or impaired GI function)
  • Untreated central nervous system (CNS) metastases
  • Pregnant or breastfeeding

Where in Italy

Also in 18 other countries, 185 sites

  • ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyTaking people
  • Fondazione IRCCS - Istituto Nazionale dei TumoriMilan, ItalyTaking people
  • Istituto Europeo di Oncologia s.r.lMilan, ItalyTaking people
  • Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
  • Fondazione IRCCS San Gerardo dei TintoriMonza, ItalyTaking people
  • Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi VanvitelliNaples, ItalyTaking people
  • IRCCS Istituto Nazionale Tumori Fondazione PascaleNaples, ItalyTaking people
  • Azienda Ospedaliero-Universitaria San Luigi GonzagaOrbassano, ItalyTaking people
  • Azienda Ospedaliero Universitaria ParmaParma, ItalyTaking people
  • Azienda Ospedaliera di PerugiaPerugia, ItalyTaking people
  • Azienda Ospedaliero Universitaria PisanaPisa, ItalyTaking people
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
  • Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata FonRome, ItalyTaking people
  • I.F.O. Istituti Fisioterapici OspitalieriRome, ItalyTaking people
  • Humanitas Mirasole S.p.A.Rozzano, ItalyTaking people
  • Azienda Ospedaliera Universitaria Integrata VeronaVerona, ItalyTaking people

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • daraxonrasibTreatment being tested

    study drug

  • docetaxelExisting treatment, for comparison

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests daraxonrasib against docetaxel in previously treated lung cancer with RAS mutationsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
6 November 2026