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.
Plain-language title generated from the registry record
Registry title: Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
Key facts
- Where
- Milan, Monza, Naples, Orbassano, Parma, Perugia, Pisa, Rome, Rozzano, and Verona, ItalySee the 16 sites
- Phase
- Phase 3
Where in Italy
- 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
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Revolution Medicines, Inc.
- Trial code
- NCT06881784EU 2024-518154-16-00
- Record updated
- 6 November 2026
- Original description
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.Read full original descriptionShow less
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.
Inclusion: 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: 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.