Trials / Recruiting
RecruitingNCT06881784
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 420 (estimated)
- Sponsor
- Revolution Medicines, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.
Detailed description
This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with daraxonrasib will improve progression free survival (PFS) or overall survival (OS) compared to docetaxel chemotherapy in patients with NSCLC who were previously treated. Patients will be randomized in a 1:1 ratio to receive daraxonrasib or docetaxel chemotherapy.
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
| Type | Name | Description |
|---|---|---|
| DRUG | daraxonrasib | oral tablets |
| DRUG | docetaxel | intravenous (IV) infusion |
Timeline
- Start date
- 2025-05-06
- Primary completion
- 2027-12-01
- Completion
- 2030-12-01
- First posted
- 2025-03-18
- Last updated
- 2026-03-12
Locations
129 sites across 19 countries: United States, Australia, Belgium, France, Germany, Hong Kong, Ireland, Italy, Japan, Netherlands, New Zealand, Poland, Puerto Rico, Singapore, South Korea, Spain, Switzerland, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06881784. Inclusion in this directory is not an endorsement.