RECRUITING

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

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Conditions

NSCLC (Non-small Cell Lung Cancer)Non-Small Cell Lung CancerNSCLCNSCLC (Non-small Cell Lung Carcinoma)NSCLC (Advanced Non-small Cell Lung Cancer)Lung CancerRASKRASHRASNRASRAS Wild-TypeRAS Q61 MutationRAS G12 MutationRAS G13 Mutation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-05-30
Study Completion:2030-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06881784

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * At least 18 years old and has provided informed consent.
  2. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  3. * Histologically confirmed NSCLC, either locally advanced or metastatic, not amenable to curative surgery or radiotherapy.
  4. * Measurable disease per RECIST v1.1.
  5. * Adequate organ function (bone marrow, liver, kidney, coagulation).
  6. * One to two prior lines of therapy including an anti-PD-1/anti-PD(L)-1 agent and platinum-based chemotherapy.
  7. * Documented RAS mutation status, defined as Nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61).
  8. * Able to take oral medications.
  1. * Prior therapy with direct RAS-targeted therapy or docetaxel.
  2. * Untreated central nervous system (CNS) metastases.
  3. * Medically significant comorbidities (significant cardiovascular disease, lung disease, or impaired GI function).
  4. * Ongoing anticancer therapy.
  5. * Pregnancy and/or breastfeeding.

Contacts and Locations

Study Contact

Revolution Medicines Study Director
CONTACT
1-844-2-REVMED
medinfo@revmed.com

Study Locations (Sites)

Taylor Cancer Research Center
Maumee, Ohio, 43537
United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106
United States

Collaborators and Investigators

Sponsor: Revolution Medicines, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-30
Study Completion Date2030-12-01

Study Record Updates

Study Start Date2025-05-30
Study Completion Date2030-12-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • 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)