NCT06881784Recruiting
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
Summary
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.
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.
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, United States, Australia, Belgium, Hong Kong, Ireland, Japan, Netherlands, New Zealand, Poland, Puerto Rico, Singapore, South Korea, Spain, Taiwan, United Kingdom
- Sponsor
- Revolution Medicines, Inc.(Industry)
- Protocol no.
- RMC-6236-301
- Conditions
- NSCLC (Non-small Cell Lung Cancer), Non-Small Cell Lung Cancer, NSCLC, NSCLC (Non-small Cell Lung Carcinoma), NSCLC (Advanced Non-small Cell Lung Cancer)
- Interventions
- Drug
Treatments studied
- daraxonrasib
- docetaxel
Locations · 158
- Basel, SwitzerlandUniversitätsspital BaselRecruiting at this site
- Fribourg, SwitzerlandHFR Fribourg/Kantonsspital FribourgRecruiting at this site
- Sankt Gallen, SwitzerlandKantonsspital St. GallenRecruiting at this site
- Strasbourg, FranceCHU Strasbourg - Nouvel Hôpital CivilRecruiting at this site
- Marseille, FranceHopital Nord - CHU MarseilleRecruiting at this site
- Montpellier, FranceInstitut régional du Cancer de MontpellierRecruiting at this site
- Rennes, FranceCHU Rennes Hôpital PontchaillouRecruiting at this site
- La Tronche, FranceCHU de Grenoble - Hôpital Albert MichallonRecruiting at this site
- Saint-Herblain, FranceCHU Nantes - Hôpital Guillaume et René LaënnecRecruiting at this site
- Saint-Herblain, FranceInstitut de Cancerologie de l OuestRecruiting at this site
- Léon, FranceCentre Leon BerardRecruiting at this site
- Lille, FranceHopital Albert Calmette - CHU LilleRecruiting at this site
- Paris, FranceHôpital Bichat - Claude BernardRecruiting at this site
- Bron, FranceHopital Louis PradelRecruiting at this site
- Créteil, FranceCentre Hospitalier Intercommunal de CréteilRecruiting at this site
- Vaillant, FranceInstitut Gustave RoussyRecruiting at this site
- Brest, FranceCHU Brest - Hôpital MorvanRecruiting at this site
- Gironde, FranceInstitut BergonieRecruiting at this site
- Toulouse, FranceCHU de Toulouse - Hopital LarreyRecruiting at this site
- Immenhausen, GermanyLKI Lungenfachklinik ImmenhausenRecruiting at this site
- Essen, GermanyUniversitaetsklinikum EssenRecruiting at this site
- Dresden, GermanyUniversitaetsklinikum Carl Gustav Carus TU DresdenRecruiting at this site
- Baden, GermanyThoraxklinik Heidelberg gGmbHRecruiting at this site
- Baden, GermanyKlinikum Esslingen GmbHRecruiting at this site
- Berlin, GermanyEvangelische Lungenklinik BerlinRecruiting at this site
- Milan, ItalyIEO Istituto Europeo di OncologiaRecruiting at this site
- Milan, ItalyAzienda Socio Sanitaria Territoriale NiguardaRecruiting at this site
- Rossano, ItalyIstituto Clinico HumanitasRecruiting at this site
- Monza, ItalyFondazione IRCCS San Gerardo dei TintoriRecruiting at this site
- Naples, ItalyIstituto Nazionale Tumori Fondazione G. PascaleRecruiting at this site
In total, worldwide, all 158 sites listed in the registry are recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: September 29, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 128 more locations
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.