Clinical trial · Interventional
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
NCT06881784CI-TRIAL-00124260RASolve 301recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| NSCLC (Advanced Non-small Cell Lung Cancer) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
| NSCLC (Non-small Cell Lung Cancer) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
| NSCLC (Non-small Cell Lung Carcinoma) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| daraxonrasib | Drug | — | UNRESOLVED |
| docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- daraxonrasib
- description
- study drug
- interventionNames
- Drug: daraxonrasib
- type
- ACTIVE_COMPARATOR
- label
- docetaxel
- description
- Patients randomized to the comparator control arm will receive docetaxel as the standard of care therapy.
- interventionNames
- Drug: docetaxel
Primary outcomes (2)
- measure
- Progression free survival (PFS) per Blinded Independent Central Review (BICR) in the RAS G12X-C population (i.e RAS G12X excluding G12C)
- timeFrame
- Up to approximately 4 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.