Recruiting
Phase 3

Daraxonrasib

Sponsor:

Revolution Medicines, Inc.

Code:

NCT06881784

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)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

daraxonrasib

docetaxel

Study Details

Brief summary:

The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.

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)

Study ID

NCT06881784

Start date

May 6, 2025

Status verified date

Jul, 2026

Completion date

Dec 1, 2030

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

590 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: daraxonrasib

study drug

active comparator: docetaxel

Patients randomized to the comparator control arm will receive docetaxel as the standard of care therapy.

Interventions

daraxonrasib

oral tablets

docetaxel

intravenous (IV) infusion

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Revolution Medicines Study Director

1-844-2-REVMEDmedinfo@revmed.com

Locations

Alabama Oncology

Recruiting

Birmingham, Alabama, United States, 35243

Contacts

Stephanie (Sherbet) Abercrombie, CRC

205-803-4369Stephanie.Abercrombie@alabamaoncology.com

MemorialCare Long Beach Medical Center

Recruiting

Long Beach, California, United States, 90806

Contacts

Yale University, Smillow Cancer Center

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Florida Cancer Specialists & Research Institute - South

Recruiting

Fort Myers, Florida, United States, 33901

Contacts

BRCR Global

Recruiting

Plantation, Florida, United States, 33322

Contacts

Cancer Care Centers of Breevard

Recruiting

Rockledge, Florida, United States, 32955

Contacts

Florida Cancer Specialists & Research Institute - North

Recruiting

St. Petersburg, Florida, United States, 33705

Contacts

Cleveland Clinic Martin North

Recruiting

Stuart, Florida, United States, 34994

Contacts

Florida Cancer Specialists & Research Institute - East

Recruiting

West Palm Beach, Florida, United States, 33401

Contacts

University Cancer and Blood Center

Recruiting

Athens, Georgia, United States, 30607

Contacts

Piedmont Healthcare, Inc

Recruiting

Atlanta, Georgia, United States, 30318

Contacts

Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

University of Illinois Cancer Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Center for Care and Discovery

Recruiting

Chicago, Illinois, United States, 60637

Contacts

University of Iowa Health Care Cancer Services Quad Cities

Recruiting

Bettendorf, Iowa, United States, 52722

Contacts

University of Iowa Hospitals & Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

University of Iowa Health Care, Mission Cancer + Blood

Recruiting

Waukee, Iowa, United States, 50263

Contacts

The University of Kansas Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

Contacts

Johns Hopkins University of Medicine

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Trinity Health Ann Arbor Hospital

Recruiting

Ann Arbor, Michigan, United States, 48106

Contacts

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Henry Ford Health

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Washington University School of Medicine - Siteman Cancer Center

Recruiting

St Louis, Missouri, United States, 63110

Contacts

St. Vincent Frontier Cancer Center

Recruiting

Billings, Montana, United States, 59102

Contacts

Dartmouth-Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

John Theurer Cancer Center at Hackensack UMC

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Oncology Clinical Research Referral Office

551-996-1777OncologyResearchReferral@hmhn.org

Morristown Medical Center (MMCORC)

Recruiting

Morristown, New Jersey, United States, 07960

Contacts

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10461

Contacts

UNC Lineberger Comprehensive Cancer Center at University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

TriHealth Cancer & Blood Institute Research

Recruiting

Cincinnati, Ohio, United States, 45220

Contacts

Taylor Cancer Research Center

Recruiting

Maumee, Ohio, United States, 43537

Contacts

Oncology Associates of Oregon PC

Recruiting

Eugene, Oregon, United States, 97401

Contacts

Penn State Milton S. Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Avera Saint Luke's Hospital

Recruiting

Aberdeen, South Dakota, United States, 57401

Contacts

Avera Cancer Institute

Recruiting

Sioux Falls, South Dakota, United States, 57105

Contacts

SCRI Oncology Partners - Tennessee

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Texas Oncology - South Austin

Recruiting

Austin, Texas, United States, 78745

Contacts

Texas Oncology Dallas

Recruiting

Dallas, Texas, United States, 75251

Contacts

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Texas Oncology - Gulf Coast

Recruiting

The Woodlands, Texas, United States, 77380

Contacts

Utah Cancer Specialists

Recruiting

Salt Lake City, Utah, United States, 84106

Contacts

Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

More Information

Sponsor

Revolution Medicines, Inc.

Last update posted

Sep 29, 2026

Last verified

Jul, 2026

Keywords

  • NSCLC
  • Non-Small Cell Lung Cancer
  • Lung Cancer
  • RAS
  • KRAS
  • HRAS
  • NRAS
  • RAS Q61 Mutation
  • RAS G12 Mutation
  • RAS G13 Mutation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-04. This information was provided to ClinicalTrials.gov by Revolution Medicines, Inc. on 2026-09-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.