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

Last updated: May 7, 2025
Sponsor: Revolution Medicines, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Non-small Cell Lung Cancer

Treatment

daraxonrasib

docetaxel

Clinical Study ID

NCT06881784
RMC-6236-301
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • At least 18 years old and has provided informed consent.

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

  • Histologically confirmed NSCLC, either locally advanced or metastatic, not amenableto 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 andplatinum-based chemotherapy.

  • Documented RAS mutation status, defined as Nonsynonymous mutations in KRAS, NRAS, orHRAS at codons 12, 13, or 61 (G12, G13, or Q61).

  • Able to take oral medications.

Exclusion

Exclusion Criteria:

  • Prior therapy with direct RAS-targeted therapy or docetaxel.

  • Untreated central nervous system (CNS) metastases.

  • Medically significant comorbidities (significant cardiovascular disease, lungdisease, or impaired GI function).

  • Ongoing anticancer therapy.

  • Pregnancy and/or breastfeeding.

Study Design

Total Participants: 420
Treatment Group(s): 2
Primary Treatment: daraxonrasib
Phase: 3
Study Start date:
May 30, 2025
Estimated Completion Date:
December 01, 2030

Study 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.

Connect with a study center

  • Pan American Center for Oncology Trials

    San Juan, 00909
    Puerto Rico

    Active - Recruiting

  • Taylor Cancer Research Center

    Maumee, Ohio 43537
    United States

    Active - Recruiting

  • Utah Cancer Specialists

    Salt Lake City, Utah 84106
    United States

    Active - Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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