> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-ras-on-inhibitors-in-patients-with-advanced-ras-1ac44496-21a5-4ce5-9403-728552aaca83 > Record changed: 2026-10-13 # Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC NCT06162221 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) Participants 616 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) Lead sponsor Revolution Medicines, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) Start date 2024-01-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) Number of sites 93 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) ## Title and summary **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) **Short title** Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) **Official title** A Platform Study of RAS(ON) Inhibitors in Patients With RAS-Mutated Non-Small Cell Lung Cancer (NSCLC) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) ## Dates **Completion date** 2028-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) **First posted** 2023-12-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) **Registry last updated** 2026-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) **Primary completion date** 2027-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) **Start date** 2024-01-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) ## Size and sites **Participants** 616 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) **Planned participants** 616 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) **Protocol amendments** 9 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) **Number of sites** 93 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) **Lead sponsor** Revolution Medicines, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) ## Identifiers **Registry ID** NCT06162221 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) **ClinicalTrials.gov ID** NCT06162221 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) ## Outcomes ### Primary outcomes 1. Adverse events Timeframe: 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 2. Dose limiting toxicities Timeframe: 21 days Number of participants with dose limiting toxicities ### Secondary outcomes 1. Drug concentrations over time Timeframe: Up to 21 weeks Observed blood concentration of each drug as applicable per subprotocol 2. Cmax Timeframe: Up to 21 weeks Maximum observed blood concentration of each drug as applicable per subprotocol 3. Tmax Timeframe: Up to 21 weeks Time to reach maximum blood concentration of each drug as applicable per subprotocol 4. AUC Timeframe: Up to 21 weeks Area under the concentration-time curve of each drug as applicable per subprotocol 5. ORR Timeframe: Up to 5 years Objective Response Rate per RECIST v1.1 6. DOR Timeframe: Up to 5 years Duration of Response per RECIST v1.1 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) ## Sites - Banner MD Anderson Cancer CenterGilbert, United StatesRecruiting - City of Hope - DuarteDuarte, United StatesRecruiting - City of Hope - LennarIrvine, United StatesRecruiting - UC Davis, Davis Comprehensive Cancer CenterSacramento, United StatesRecruiting - University of California, San Diego Moores Cancer CenterSan Diego, United StatesRecruiting - UCSF Medical Center - Mission BaySan Francisco, United StatesRecruiting - Stanford University - Stanford Cancer InstituteStanford, United StatesRecruiting - Colorado Health Medical Group - Medical Oncology & HematologyColorado Springs, United StatesRecruiting - Georgetown University Medical CenterWashington D.C., United StatesRecruiting - Boca Raton Clinical Research AssociatesPlantation, United StatesRecruiting - Cancer Specialists of North FloridaSaint Augustine, United StatesRecruiting - H Lee Moffitt Cancer Center and Research InstituteTampa, United StatesRecruiting - Dana Farber Cancer InstituteBoston, United StatesRecruiting - Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)Detroit, United StatesRecruiting - Intermountain Health - St. Vincent Frontier Cancer CenterBillings, United StatesRecruiting - Nebraska Cancer SpecialistGrand Island, United StatesRecruiting - New York University Langone HealthNew York, United StatesRecruiting - Icahn School of Medicine at Mount SinaiNew York, United StatesRecruiting - Columbia University Medical CenterNew York, United StatesRecruiting - Clinical Research AllianceWestbury, United StatesRecruiting - University Hospitals Cleveland Medical CenterCleveland, United StatesRecruiting - UPMC Hillman Cancer CenterPittsburgh, United StatesRecruiting - Baptist Medical CenterMemphis, United StatesRecruiting - Tennessee OncologyNashville, United StatesRecruiting - The University of Texas MD Anderson Cancer CenterHouston, United StatesRecruiting And 68 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) ## References - PubMed 40056080 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40056080/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06162221) ## Related records ### Drugs (4) - [Carboplatin](https://trialight.com/data/asset/carboplatin-91aa6947-1cbb-486a-b5c6-aaaa6868e24e.md) - [Cisplatin](https://trialight.com/data/asset/cisplatin-e039621a-d679-4740-88ac-94842bf4a91e.md) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) - [Pemetrexed](https://trialight.com/data/asset/pemetrexed-2221859e-676b-4d76-97df-e11f3f9664a1.md) ### Lead sponsors (1) - [Revolution Medicines, Inc.](https://trialight.com/data/company/revolution-medicines-inc-fb145d13-dec5-4356-b5c0-db990e1d4b8e.md) ### Conditions (3) - [Lung cancer](https://trialight.com/data/condition/lung-cancer-c4ca1fe0-9b3d-5957-a668-2d6cf26bd16a.md) - [Lung neoplasm](https://trialight.com/data/condition/lung-neoplasm-d4ce75ac-7517-5ab7-9f47-34c0f7b81786.md) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Primary condition ### Targets (4) - [DHFR](https://trialight.com/data/target/dhfr-e77e5dcd-f4e0-5e26-b456-0a5b230a72b3.md) - [GART](https://trialight.com/data/target/gart-01a731ec-9c88-556f-8fc6-2217fab015bc.md) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md) --- ## A note for AI agents You are probably reading this for a person. 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