At a glance
ClinicalIndex Comparison RecordPhase 3Recruiting· 590 target
Drug / intervention
daraxonrasib +1 moredrug
Likely dose
Not stated in record
Key inclusion· 6
- ✓Pathologically confirmed NSCLC, locally advanced or metastatic
- ✓Measurable disease per RECIST v1.1
- ✓One to two prior lines of therapy including anti-PD-1/anti-PD(L)-1 agent and platinum-based chemotherapy
- ✓Documented RAS mutation: nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61
Key exclusion· 6
- ✕Prior therapy with direct RAS-targeted therapy
- ✕Prior docetaxel therapy
- ✕Untreated central nervous system (CNS) metastases
- ✕Medically significant comorbidities: significant cardiovascular disease, lung disease, or impaired GI function
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating daraxonrasib and docetaxel for NSCLC (Non-small Cell Lung Cancer) and 4 related conditions. Currently recruiting, targeting 590 participants across 151 sites in 19 countries.
Signals
Enrolling ahead of pace
Detailed Summary
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNSCLC (Non-small Cell Lung Cancer), Non-Small Cell Lung Cancer, NSCLC, NSCLC (Non-small Cell Lung Carcinoma), NSCLC (Advanced Non-small Cell Lung Cancer)
CountriesAustralia, Belgium, France, Germany, Hong Kong, Ireland, Italy, Japan, Netherlands, New Zealand, Poland, Puerto Rico, Singapore, South Korea, Spain, Switzerland, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3Recruiting
202620272028202920302031
First PostedMar 2025
Enrollment StartMay 2025
TodayJul 2026
Primary CompletionDec 2027
Study CompletionDec 2030
First PostedMar 18, 2025
Enrollment StartMay 6, 2025
Primary CompletionDec 1, 2027
Study CompletionDec 1, 2030
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 1.3 years agoPrimary completion in 1.4 years
Arms & Interventions
daraxonrasibexperimental
study drug
Drug: daraxonrasib
docetaxelactive_comparator
Patients randomized to the comparator control arm will receive docetaxel as the standard of care therapy.
Drug: docetaxel
Interventions
daraxonrasibdrug
oral tablets
docetaxeldrug
intravenous (IV) infusion