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

a study on Lung Cancer Non-Small Cell Lung Cancer Lung Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
study ends around
Principal Investigator
by Zhaohui Arter (uci)

Description

Summary

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

Official Title

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

Details

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.

Keywords

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), Lung Cancer, RAS, KRAS, HRAS, NRAS, RAS Q61 Mutation, RAS G12 Mutation, RAS G13 Mutation, Non-Small-Cell Lung Carcinoma, Lung Neoplasms, Docetaxel, daraxonrasib

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • UC Irvine Health accepting new patients
    Orange California 92868 United States
  • MemorialCare Long Beach Medical Center in progress, not accepting new patients
    Long Beach California 90806 United States
  • Aichi Cancer Center Hospital accepting new patients
    Nagoya Aichi-ken 464-8681 Japan
  • Fujita Health University Hospital accepting new patients
    Toyoake-shi Aichi-ken 470-1192 Japan
  • National Cancer Center Hospital East accepting new patients
    Kashiwa-shi Chiba 277-8577 Japan
  • NHO Himeji Medical Center accepting new patients
    Matsuyama Ehime 791-0280 Japan
  • NHO Shikoku Cancer Center accepting new patients
    Matsuyama Ehime 791-0280 Japan
  • National Hospital Organization Hokkaido Cancer Center accepting new patients
    Sapporo Hokkaido 003-0804 Japan
  • Hyogo Cancer Center accepting new patients
    Akashi Hyōgo 673-8558 Japan
  • Kanazawa University Hospital accepting new patients
    Kanazawa Ishikawa-ken 920-8641 Japan

Lead Scientist at University of California Health

  • Zhaohui Arter (uci)
    Assistant Health Sciences Professor, Medicine, School of Medicine. Authored (or co-authored) 44 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Revolution Medicines, Inc.
ID
NCT06881784
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 590 study participants
Last Updated
Contact us about this trial