RECRUITING

Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC

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Conditions

Non-Small Cell Lung Cancer, NSCLCKRAS, NRAS, HRAS-mutated NSCLCKRAS G12C-mutated Solid Tumors, Lung CancerLung Cancer Stage IV, Advanced Solid Tumor, CancerRAS G12D-mutated NSCLCNSCLCKRAS G12CRAS MutationKRAS G12XNon-Small Cell Lung CancerLung CancerLung Cancer Stage IVAdvanced Solid TumorCancerRAS G12D

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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 platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors as a monotherapy or combined with Standard(s) of Care (SOC) or with each other. The first four subprotocols include the following: Subprotocol A: RMC-6291 +/- RMC-6236 + SOC Subprotocol B: RMC-6236 + SOC Subprotocol C: RMC-9805 +/- RMC-6236 + SOC Subprotocol D: RMC-9805

Official Title

A Platform Study of RAS(ON) Inhibitors in Patients With RAS-Mutated Non-Small Cell Lung Cancer (NSCLC)

Quick Facts

Study Start:2024-01-18
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06162221

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. * ≥ 18 years of age
  2. * ECOG PS is 0 to 1
  3. * Adequate organ function as outlined by the study
  4. * Received prior standard therapy appropriate for tumor type and stage
  5. * Must have pathologically documented, locally advanced or metastatic KRAS G12C-mutated solid tumor malignancy (not amenable to curative surgery) (Subprotocol A)
  6. * Must have pathologically documented, locally advanced or metastatic RAS-mutated NSCLC (Subprotocol B)
  7. * Must have pathologically documented, locally advanced or metastatic RAS G12D-mutated NSCLC (Subprotocol C and Subprotocol D)
  1. * Primary central nervous system (CNS) tumors
  2. * Impaired gastrointestinal (GI) function that may significantly alter the absorption of RMC drugs
  3. * Major surgery \< 28 days of first dose
  4. * Active or history of interstitial lung disease (ILD) or pneumonitis requiring steroids

Contacts and Locations

Study Contact

Revolution Medicines
CONTACT
1-844-2-REVMED
medinfo@RevMed.com

Principal Investigator

Revolution Medicines
STUDY_DIRECTOR
Revolution Medicines

Study Locations (Sites)

City of Hope - Duarte
Duarte, California, 91010
United States
City of Hope - Lennar
Irvine, California, 92618
United States
UC Davis, Davis Comprehensive Cancer Center
Sacramento, California, 95817
United States
University of California, San Diego Moores Cancer Center
San Diego, California, 92037
United States
UCSF Medical Center - Mission Bay
San Francisco, California, 94158
United States
Stanford University - Stanford Cancer Institute
Stanford, California, 94305
United States
Georgetown University Medical Center
Washington, District of Columbia, 20007
United States
Boca Raton Clinical Research Associates
Plantation, Florida, 33322
United States
Cancer Specialists of North Florida
St Augustine, Florida, 32086
United States
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
United States
Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)
Detroit, Michigan, 48202
United States
Intermountain Health - St. Vincent Frontier Cancer Center
Billings, Montana, 59102
United States
New York University Langone Health
New York, New York, 10016
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Columbia University Medical Center
New York, New York, 10032
United States
Clinical Research Alliance
Westbury, New York, 11590
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
NEXT Oncology Dallas
Irving, Texas, 75039
United States
NEXT Oncology Virginia
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Revolution Medicines, Inc.

  • Revolution Medicines, STUDY_DIRECTOR, Revolution Medicines

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 Date2024-01-18
Study Completion Date2028-12

Study Record Updates

Study Start Date2024-01-18
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • NSCLC
  • KRAS G12C
  • RAS Mutation
  • KRAS G12X
  • Non-Small Cell Lung Cancer
  • Lung Cancer
  • Lung Cancer Stage IV
  • Advanced Solid Tumor
  • Cancer
  • RAS G12D

Additional Relevant MeSH Terms

  • Non-Small Cell Lung Cancer, NSCLC
  • KRAS, NRAS, HRAS-mutated NSCLC
  • KRAS G12C-mutated Solid Tumors, Lung Cancer
  • Lung Cancer Stage IV, Advanced Solid Tumor, Cancer
  • RAS G12D-mutated NSCLC