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Study of Daraxonrasib for RAS-Mutated Non-Small Cell Lung Cancer

This study is testing a new oral medication called daraxonrasib for people with non-small cell lung cancer (NSCLC) that has a specific change in the RAS gene (RAS mutated). Researchers want to see if daraxonrasib is safer and more effective than docetaxel, a chemotherapy given through an IV. To join, you must be at least 18 years old, have NSCLC that has spread or cannot be removed by surgery or radiation, and have a good general health status (ECOG performance status of 0 or 1). The study will measure how long people live without their cancer getting worse (progression-free survival) and how long they live overall (overall survival). The study is currently recruiting about 590 participants.

Study design
This is a global, randomized, open-label Phase 3 study. Participants will be randomly assigned to receive either daraxonrasib or docetaxel.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately 4 years to measure progression-free survival and overall survival.

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NCT06881784

Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)

Recruiting
PHASE3Ages 18+InterventionalTreatment
Revolution Medicines, Inc.
~590 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:daraxonrasibdocetaxel

At a glance

Recruiting sites
153 of 153 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival (PFS) per Blinded Independent Central Review (BICR) in the RAS G12X-C population (i.e RAS G12X excluding G12C)
Measured over Up to approximately 4 years
+1 more outcome measured

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)

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

153 sites across 89 states
Florida6
New South Wales5
Belgium5
Netherlands5
South Korea5
Taiwan5
Texas4
Hong Kong4

Who to contact

Revolution Medicines Study Director
[email protected]
1-844-2-REVMED
Email the study team

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Eligibility criteria

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.
Untreated central nervous system (CNS) metastases.
Medically significant comorbidities (significant cardiovascular disease, lung disease, or impaired GI function).
Ongoing anticancer therapy.
Pregnant or breastfeeding.

What this trial measures

  • Progression free survival (PFS) per Blinded Independent Central Review (BICR) in the RAS G12X-C population (i.e RAS G12X excluding G12C)Up to approximately 4 years

    PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per response evaluation criteria in solid tumors (RECIST) v1.1 and as assessed by BICR.

  • Overall survival (OS) in the RAS G12X-C populationUp to approximately 4 years

    OS is defined as the time from randomization until death from any cause.