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

RecruitingPhase 1/2

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion criteria:

All Patients (unless otherwise noted):

* ≥ 18 years of age
* ECOG PS is 0 to 1
* Adequate organ function as outlined by the study
* Received prior standard therapy appropriate for tumor type and stage
* Must have pathologically documented, locally advanced or metastatic KRAS G12C-mutated solid tumor malignancy (not amenable to curative surgery) (Subprotocol A)
* Must have pathologically documented, locally advanced or metastatic RAS-mutated NSCLC (Subprotocol B)
* Must have pathologically documented, locally advanced or metastatic RAS G12D-mutated NSCLC (Subprotocol C and Subprotocol D)

Exclusion criteria:

All Patients:

* Primary central nervous system (CNS) tumors
* Impaired gastrointestinal (GI) function that may significantly alter the absorption of RMC drugs
* Major surgery \< 28 days of first dose
* Active or history of interstitial lung disease (ILD) or pneumonitis requiring steroids

Other inclusion/exclusion criteria may apply.

About the study

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

What is being tested

Sponsor: Revolution Medicines, Inc. · Participants: 616 · Started: Jan 18, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06162221

Locations in the U.S.

ArizonaBanner MD Anderson Cancer Center, Gilbert
CaliforniaCity of Hope - Duarte, Duarte
City of Hope - Lennar, Irvine
UC Davis, Davis Comprehensive Cancer Center, Sacramento
University of California, San Diego Moores Cancer Center, San Diego
UCSF Medical Center - Mission Bay, San Francisco
Stanford University - Stanford Cancer Institute, Stanford
ColoradoColorado Health Medical Group - Medical Oncology & Hematology, Colorado Springs
District of ColumbiaGeorgetown University Medical Center, Washington D.C.
FloridaBoca Raton Clinical Research Associates, Plantation
Cancer Specialists of North Florida, Saint Augustine
H Lee Moffitt Cancer Center and Research Institute, Tampa
MassachusettsDana Farber Cancer Institute, Boston
MichiganHenry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion), Detroit
MontanaIntermountain Health - St. Vincent Frontier Cancer Center, Billings
NebraskaNebraska Cancer Specialist, Grand Island
New YorkColumbia University Medical Center, New York
Icahn School of Medicine at Mount Sinai, New York
New York University Langone Health, New York
Clinical Research Alliance, Westbury
OhioUniversity Hospitals Cleveland Medical Center, Cleveland
PennsylvaniaUPMC Hillman Cancer Center, Pittsburgh
TennesseeBaptist Medical Center, Memphis
Tennessee Oncology, Nashville
TexasThe University of Texas MD Anderson Cancer Center, Houston
NEXT Oncology Dallas, Irving
VirginiaNEXT Oncology Virginia, Fairfax
WashingtonFred Hutchinson Cancer Research Center, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.