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

NCT06162221
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Phase
Phase 1/Phase 2
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Recruitment status
Recruiting
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Participants
616
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Lead sponsor
Revolution Medicines, Inc.
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Start date
2024-01-18
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Number of sites
93
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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
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Short title
Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC
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Official title
A Platform Study of RAS(ON) Inhibitors in Patients With RAS-Mutated Non-Small Cell Lung Cancer (NSCLC)
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2028-12-01
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First posted
2023-12-08
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Registry last updated
2026-06-30
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Primary completion date
2027-06-01
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Start date
2024-01-18
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Participants
616
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Participant count basis
Estimated
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Planned participants
616
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Protocol amendments
9
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Number of sites
93
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Revolution Medicines, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06162221
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ClinicalTrials.gov ID
NCT06162221
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Registry record
Open registry record
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Allocation
Not randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  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

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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)

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
clinicaltrials.gov

  • 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
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (4)

Lead sponsors (1)

Conditions (3)

Targets (4)