Home › Trials › NCT06881784

Evaluating daraxonrasib for previously treated patients with RAS mutated lung cancer

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

Phase 3 Interventional Revolution Medicines, Inc. · NCT06881784

This study is testing if a new drug called daraxonrasib can help people with RAS mutated lung cancer live longer and feel better compared to standard chemotherapy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment420 (estimated)
Ages18 Years and up
SexAll
SponsorRevolution Medicines, Inc. Industry-sponsored
Drugs / interventionschemotherapy
Locations129 sites (Birmingham, Alabama and 128 other locations)
Trial IDNCT06881784 on ClinicalTrials.gov

What this trial studies

This global, randomized, open-label Phase 3 study aims to assess the safety and efficacy of daraxonrasib, a novel RAS(ON) inhibitor, compared to standard docetaxel chemotherapy in patients with previously treated non-small cell lung cancer (NSCLC). Participants will be randomly assigned in a 1:1 ratio to receive either daraxonrasib or docetaxel. The primary focus is to determine if daraxonrasib can improve progression-free survival (PFS) or overall survival (OS) in this patient population. Eligible patients must have documented RAS mutations and measurable disease.

Who should consider this trial

Good fit: Ideal candidates are adults with previously treated NSCLC who have documented RAS mutations and meet specific health criteria.

Not a fit: Patients who have previously received direct RAS-targeted therapy or docetaxel, or those with untreated CNS metastases, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option that improves survival outcomes for patients with RAS mutated NSCLC.

How similar studies have performed: Other studies have shown promise with RAS-targeted therapies, but this specific approach with daraxonrasib is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 128 other locations

+79 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions NSCLCNon-Small Cell Lung CancerLung CancerRASKRASHRASNRASRAS Q61 Mutation
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.