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

NCT06162221 · tracked via the Priya Life Science Italy tracker

Sponsor

Revolution Medicines, Inc

Phase

Phase 1/2

Started

2024-01-18

Last updated

2026-06-30

Condition(s) studied

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 NSCLC

Investigational drug(s) / intervention(s)

RMC-6291 →RMC-6236 →Pembrolizumab →Cisplatin →Carboplatin →Pemetrexed →RMC-9805 →

RMC-6291: Oral tablet

RMC-6236: Oral tablet

Pembrolizumab: IV Infusion

Cisplatin: IV Infusion

Carboplatin: IV Infusion

Pemetrexed: IV infusion

RMC-9805: Oral Tablet

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Adverse events — Up to 5 years
Incidence and severity of treatment-emergent Adverse Events (AEs) and serious AEs and clinically significant changes in laboratory values, ECGs and vital signs
Dose limiting toxicities — 21 days
Number of participants with dose limiting toxicities

Trial sites (93)

Facility	City	Region	Status
Banner MD Anderson Cancer Center	Gilbert	Arizona	Recruiting
City of Hope - Duarte	Duarte	California	Recruiting
City of Hope - Lennar	Irvine	California	Recruiting
UC Davis, Davis Comprehensive Cancer Center	Sacramento	California	Recruiting
University of California, San Diego Moores Cancer Center	San Diego	California	Recruiting
UCSF Medical Center - Mission Bay	San Francisco	California	Recruiting
Stanford University - Stanford Cancer Institute	Stanford	California	Recruiting
Colorado Health Medical Group - Medical Oncology & Hematology	Colorado Springs	Colorado	Recruiting
Georgetown University Medical Center	Washington D.C.	District of Columbia	Recruiting
Boca Raton Clinical Research Associates	Plantation	Florida	Recruiting
Cancer Specialists of North Florida	Saint Augustine	Florida	Recruiting
H Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	Recruiting
Dana Farber Cancer Institute	Boston	Massachusetts	Recruiting
Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)	Detroit	Michigan	Recruiting
Intermountain Health - St. Vincent Frontier Cancer Center	Billings	Montana	Recruiting
Nebraska Cancer Specialist	Grand Island	Nebraska	Recruiting
New York University Langone Health	New York	New York	Recruiting
Icahn School of Medicine at Mount Sinai	New York	New York	Recruiting
Columbia University Medical Center	New York	New York	Recruiting
Clinical Research Alliance	Westbury	New York	Recruiting
University Hospitals Cleveland Medical Center	Cleveland	Ohio	Recruiting
UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania	Recruiting
Baptist Medical Center	Memphis	Tennessee	Recruiting
Tennessee Oncology	Nashville	Tennessee	Recruiting
The University of Texas MD Anderson Cancer Center	Houston	Texas	Recruiting
NEXT Oncology Dallas	Irving	Texas	Recruiting
NEXT Oncology Virginia	Fairfax	Virginia	Recruiting
Fred Hutchinson Cancer Research Center	Seattle	Washington	Recruiting
Chris O'Brien Lifehouse Hosptial	Camperdown	New South Wales	Recruiting
Liverpool Hospital	Liverpool	New South Wales	Recruiting
Royal North Shore Hospital	St Leonards	New South Wales	Recruiting
Monash Health	Clayton	Victoria	Recruiting
Linear Clinical Research	Nedlands	Western Australia	Recruiting
Universitätsklinikum St. Pölten	Sankt Pölten	Austria	Recruiting
Nemocnice AGEL Novy Jicin a.s	Nový Jičín	Czech Republic	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	Recruiting
Centre Georges François Leclerc	Dijon	Bourgogne-Franche-Comté	Recruiting
CHU de Lille Institut Cœur Poumon	Lille	Hauts-de-France	Recruiting

+ 53 more sites — see the full list on the official registry below.

On this site

📄 Keytruda (pembrolizumab) drug profile →

More Revolution Medicines, Inc. trials in Italy

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

Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors Active, not recruiting

Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC) Recruiting

Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors Recruiting

Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06162221 on ClinicalTrials.gov ↗ ← All trials in Italy