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
- Akashi, Chuo Ku, Hidaka, Hirakata-shi, Kanazawa, Kashihara-shi, Kashiwa-shi, Koto-Ku, Kyoto, Matsuyama, Nagaizumi-chō, Nagoya, Niigata, Osakasayama-Shi, Sagamihara, Sapporo, Sendai, Toyoake-shi, Wakayama, and Yokohama, JapanSee the 22 sites
- Phase
- Phase 3
Where in Japan
- Hyogo Cancer CenterAkashi, JapanTaking people
- National Cancer Center HospitalChuo Ku, JapanTaking people
- Saitama Medical University International Medical CenterHidaka, JapanTaking people
- Kansai Medical University HospitalHirakata-shi, JapanTaking people
- Kanazawa University HospitalKanazawa, JapanTaking people
- Nara Medical University HospitalKashihara-shi, JapanTaking people
- National Cancer Center Hospital EastKashiwa-shi, JapanTaking people
- Cancer Institute Hospital of JFCRKoto-Ku, JapanTaking people
- University Hospital Kyoto Prefectural University of MedicineKyoto, JapanTaking people
- NHO Himeji Medical CenterMatsuyama, JapanTaking people
- NHO Shikoku Cancer CenterMatsuyama, JapanTaking people
- Shizuoka Cancer CenterNagaizumi-chō, JapanTaking people
- Aichi Cancer Center HospitalNagoya, JapanTaking people
- Niigata Cancer CenterNiigata, JapanTaking people
- Kindai University HospitalOsakasayama-Shi, JapanTaking people
- Kitasato University HospitalSagamihara, JapanTaking people
- National Hospital Organization Hokkaido Cancer CenterSapporo, JapanTaking people
- Sendai Kousei HospitalSendai, JapanTaking people
- Tohoku University HospitalSendai, JapanTaking people
- Fujita Health University HospitalToyoake-shi, JapanTaking people
- Wakayama Medical University HospitalWakayama, JapanTaking people
- Kanagawa Cancer CenterYokohama, JapanTaking 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.