Evaluating RAS inhibitors for advanced lung cancer
A Platform Study of RAS(ON) Inhibitors in Patients With RAS-Mutated Non-Small Cell Lung Cancer (NSCLC)
PHASE1; PHASE2 · Revolution Medicines, Inc. · NCT06162221
This study is testing new RAS inhibitors combined with standard treatments to see if they can help people with advanced lung cancer that has specific RAS mutations.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 616 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Revolution Medicines, Inc. (industry) |
| Drugs / interventions | pembrolizumab, chemotherapy |
| Locations | 89 sites (Gilbert, Arizona and 88 other locations) |
| Trial ID | NCT06162221 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of novel RAS(ON) inhibitors in combination with standard cancer treatments for patients with advanced RAS-mutated non-small cell lung cancer (NSCLC). The study is structured as a platform trial with three subprotocols, each focusing on different combinations of RAS inhibitors and standard therapies. Patients with specific RAS mutations will be enrolled to determine the recommended doses and schedules for these treatments.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with advanced RAS-mutated NSCLC who have previously received standard therapy.
Not a fit: Patients with primary central nervous system tumors or significant gastrointestinal function impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new effective treatment options for patients with advanced RAS-mutated NSCLC.
How similar studies have performed: Other studies have shown promise with similar approaches targeting RAS mutations, indicating potential for success in this novel treatment strategy.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Gilbert, Arizona and 88 other locations
- Banner MD Anderson Cancer Center — Gilbert, Arizona, United States (RECRUITING)
- City of Hope - Duarte — Duarte, California, United States (RECRUITING)
- City of Hope - Lennar — Irvine, California, United States (RECRUITING)
- UC Davis, Davis Comprehensive Cancer Center — Sacramento, California, United States (RECRUITING)
- University of California, San Diego Moores Cancer Center — San Diego, California, United States (RECRUITING)
- UCSF Medical Center - Mission Bay — San Francisco, California, United States (RECRUITING)
- Stanford University - Stanford Cancer Institute — Stanford, California, United States (RECRUITING)
- Georgetown University Medical Center — Washington D.C., District of Columbia, United States (RECRUITING)
- Boca Raton Clinical Research Associates — Plantation, Florida, United States (RECRUITING)
- Cancer Specialists of North Florida — Saint Augustine, Florida, United States (RECRUITING)
- H Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States (RECRUITING)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (RECRUITING)
- Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion) — Detroit, Michigan, United States (RECRUITING)
- Intermountain Health - St. Vincent Frontier Cancer Center — Billings, Montana, United States (RECRUITING)
- Nebraska Cancer Specialist — Grand Island, Nebraska, United States (RECRUITING)
- New York University Langone Health — New York, New York, United States (RECRUITING)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (RECRUITING)
- Columbia University Medical Center — New York, New York, United States (RECRUITING)
- Clinical Research Alliance — Westbury, New York, United States (RECRUITING)
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (RECRUITING)
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (RECRUITING)
- Baptist Medical Center — Memphis, Tennessee, United States (RECRUITING)
- Tennessee Oncology — Nashville, Tennessee, United States (RECRUITING)
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
- NEXT Oncology Dallas — Irving, Texas, United States (RECRUITING)
- NEXT Oncology Virginia — Fairfax, Virginia, United States (RECRUITING)
- Chris O'Brien Lifehouse Hosptial — Camperdown, New South Wales, Australia (RECRUITING)
- Liverpool Hospital — Liverpool, New South Wales, Australia (RECRUITING)
- Royal North Shore Hospital — St Leonards, New South Wales, Australia (RECRUITING)
- Monash Health — Clayton, Victoria, Australia (RECRUITING)
- Linear Clinical Research — Nedlands, Western Australia, Australia (RECRUITING)
- Rigshospitalet — Copenhagen, Denmark (RECRUITING)
- Odense University Hospital, Department of Oncology — Odense, Denmark (RECRUITING)
- Hospices Civils de Lyon - Hôpital Louis Pradel — Bron, Auvergne-Rhône-Alpes, France (RECRUITING)
- Centre Georges François Leclerc — Dijon, Bourgogne-Franche-Comté, France (RECRUITING)
- CHU de Lille Institut Cœur Poumon — Lille, Hauts-de-France, France (RECRUITING)
- CHU de Nantes — Nantes, Hauts-de-France, France (RECRUITING)
- EDOG - Institut Bergonié — Bordeaux, New Aquitaine, France (RECRUITING)
- Institut de Cancerologie de Ouest (ICO) - Angers — Angers, France (RECRUITING)
- Ambroise-Paré Hospital — Boulogne, France (RECRUITING)
- Centre François Baclesse — Caen, France (RECRUITING)
- Hôpital Cochin — Paris, France (RECRUITING)
- Hopital Tenon - AP-HP — Paris, France (RECRUITING)
- Hopital Foch — Suresnes, France (RECRUITING)
- Oncopole Claudius Regaud — Toulouse, France (RECRUITING)
- Institut Gustave Roussy — Villejuif, France (RECRUITING)
- Institut Curie — Paris, Île-de-France Region, France (RECRUITING)
- Charite-Universitaetsmedizin Berlin - Campus Charite Mitte — Berlin, Germany (RECRUITING)
- Uniklinik Köln — Cologne, Germany (RECRUITING)
- Universitätsklinikum Carl Gustav Carus an der TU Dresden — Dresden, Germany (RECRUITING)
+39 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Revolution Medicines
- Email: medinfo@RevMed.com
- Phone: 1-844-2-REVMED
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: 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, NSCLC, KRAS G12C, RAS Mutation