Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC
Recruiting · NCT06162221 · Interventional (participants receive a specific treatment) · Lead sponsor: Revolution Medicines, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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
- ther inclusion/exclusion criteria may apply.
Where it is running
60 locations listed across 16 US states.
- Banner MD Anderson Cancer Center - Gilbert, Arizona, United States
- City of Hope - Duarte - Duarte, California, United States
- City of Hope - Lennar - Irvine, California, United States
- UC Davis, Davis Comprehensive Cancer Center - Sacramento, California, United States
- University of California, San Diego Moores Cancer Center - San Diego, California, United States
- UCSF Medical Center - Mission Bay - San Francisco, California, United States
- Stanford University - Stanford Cancer Institute - Stanford, California, United States
- Colorado Health Medical Group - Medical Oncology & Hematology - Colorado Springs, Colorado, United States
- Georgetown University Medical Center - Washington D.C., District of Columbia, United States
- Boca Raton Clinical Research Associates - Plantation, Florida, United States
- Cancer Specialists of North Florida - Saint Augustine, Florida, United States
- H Lee Moffitt Cancer Center and Research Institute - Tampa, Florida, United States
- Dana Farber Cancer Institute - Boston, Massachusetts, United States
- Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion) - Detroit, Michigan, United States
- Intermountain Health - St. Vincent Frontier Cancer Center - Billings, Montana, United States
- Nebraska Cancer Specialist - Grand Island, Nebraska, United States
- New York University Langone Health - New York, New York, United States
- Icahn School of Medicine at Mount Sinai - New York, New York, United States
- Columbia University Medical Center - New York, New York, United States
- Clinical Research Alliance - Westbury, New York, United States
- University Hospitals Cleveland Medical Center - Cleveland, Ohio, United States
- UPMC Hillman Cancer Center - Pittsburgh, Pennsylvania, United States
- Baptist Medical Center - Memphis, Tennessee, United States
- Tennessee Oncology - Nashville, Tennessee, United States
- The University of Texas MD Anderson Cancer Center - Houston, Texas, United States
- NEXT Oncology Dallas - Irving, Texas, United States
- NEXT Oncology Virginia - Fairfax, Virginia, United States
- Fred Hutchinson Cancer Research Center - Seattle, Washington, United States
- Complejo Hospitalario Universitario A Coruña - A Coruña, Spain
- The Netherlands Cancer Institute (NKI) - Amsterdam, Netherlands
- Institut de Cancerologie de Ouest (ICO) - Angers - Angers, France
- Henry Dunant Hospital Center - Athens, Greece
- Thoracic General Hospital of Athens "I SOTIRIA" - Athens, Greece
- Hospital Universitari Vall D' Hebron - Barcelona, Spain
- ICO Badalona - H.U. Germans Trias i Pujol - Barcelona, Spain
- Charite-Universitaetsmedizin Berlin - Campus Charite Mitte - Berlin, Germany
- Ambroise-Paré Hospital - Boulogne, France
- Centre François Baclesse - Caen, France
- Uniklinik Köln - Cologne, Germany
- Rigshospitalet - Copenhagen, Denmark
- Universitätsklinikum Carl Gustav Carus an der TU Dresden - Dresden, Germany
- Universitätsklinikum Frankfurt - Frankfurt am Main, Germany
- University Medical Centre Groningen - Groningen, Netherlands
- Thoraxklinik Heidelberg gGmbH - Universitätsklinikum Heidelberg - Heidelberg, Germany
- Lungenfachklinik Immenhausen - Immenhausen, Germany
- Kaohsiung Medical University Chung-Ho Memorial Hospital - Kaohsiung City, Taiwan
- Leiden University Medical Center - Leiden, Netherlands
- Hospital Universitario Ramon y Cajal - Madrid, Spain
- Hospital Universitario Fundacion Jimenez Diaz - Madrid, Spain
- Fondazione IRCCS Istituto Nazionale dei tumori - Milan, Italy
- ASST Grande Ospedale Metropolitano Niguarda - Milan, Italy
- Krankenhaus Bethanien Moers - Moers, Germany
- Hospital Regional Universitario de Malaga - Hospital Civil - Málaga, Spain
- Odense University Hospital, Department of Oncology - Odense, Denmark
- A.O.U. San Luigi Gonzaga-Orbassano - SCDU Oncologia Medica - Orbassano, Italy
- Hôpital Cochin - Paris, France
- Hopital Tenon - AP-HP - Paris, France
- Ospedale Santa Maria Delle Croci - Ravenna, Italy
- IRCCS Instituto Nazionale tumori Ragina Elena - Rome, Italy
- Fondazione Policlinico Universitario A Gemelli-Rome - Rome, Italy
Showing 60 of 93 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →