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Trial record 1 of 1 for:    4630-03
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Combination Study of RMC-4630 and Sotorasib for NSCLC Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies

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ClinicalTrials.gov Identifier: NCT05054725
Recruitment Status : Active, not recruiting
First Posted : September 23, 2021
Last Update Posted : April 3, 2023
Sponsor:
Collaborators:
Sanofi
Amgen
Information provided by (Responsible Party):
Revolution Medicines, Inc.

Tracking Information
First Submitted Date  ICMJE September 14, 2021
First Posted Date  ICMJE September 23, 2021
Last Update Posted Date April 3, 2023
Actual Study Start Date  ICMJE December 30, 2021
Estimated Primary Completion Date September 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2021)		 Objective response rate (ORR) [ Time Frame: approximately 12 months ]
ORR as assessed per RECIST v1.1
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2021)
  • Adverse Events [ Time Frame: approximately 12 months ]
    Number of Participants with Adverse Events
  • Serious Adverse Events [ Time Frame: approximately 12 months ]
    Number of Participants with Serious Adverse Events
  • Vital signs [ Time Frame: approximately 12 months ]
    Number of subjects with clinically significant changes in vital signs
  • Clinical laboratory test values [ Time Frame: approximately 12 months ]
    Number of subjects with clinically significant changes in clinical laboratory test values
  • ECGs Measurements [ Time Frame: approximately 12 months ]
    Number of subjects with clinically significant changes in ECGs Measurements
  • Concentration of RMC-4630 [ Time Frame: approximately 12 months ]
    Trough Concentration of RMC-4630
  • Concentration of sotorasib [ Time Frame: approximately 12 months ]
    Trough Concentration of sotorasib
  • Duration of response (DOR) [ Time Frame: approximately 12 months ]
    DOR as assessed by RECIST v1.1
  • Disease Control Rate (DCR) [ Time Frame: approximately 12 months ]
    DCR as assessed by RECIST v1.1
  • Progression-free survival (PFS) [ Time Frame: approximately 12 months ]
    PFS as assessed by RECIST v1.1
  • Overall survival (OS) [ Time Frame: approximately 12 months ]
    Overall survival (OS)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Study of RMC-4630 and Sotorasib for NSCLC Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies
Official Title  ICMJE A Phase 2, Open-Label, Multicenter Study of the Combination of RMC-4630 and Sotorasib for Non-Small Cell Lung Cancer Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies
Brief Summary The purpose of this study is to evaluate the antitumor effects of sotorasib and RMC-4630 in subjects with KRASG12C mutant NSCLC
Detailed Description This is a phase 2 multicenter, open-label study evaluating the efficacy, safety, tolerability, and pharmacokinetics (PK) of RMC-4630 in combination with sotorasib in subjects with KRASG12C mutant NSCLC after failure of prior standard therapies.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: RMC-4630
    RMC-4630 administered orally as a capsule
    Other Name: SAR442720
  • Drug: Sotorasib
    Sotorasib administered orally as a tablet
    Other Names:
    • AMG 510
    • Lumakras
Study Arms  ICMJE
  • Experimental: RMC-4630 and sotorasib, Safety Run-in

    Safety Run-In:

    RMC-4630 and sotorasib

    Interventions:
    • Drug: RMC-4630
    • Drug: Sotorasib
  • Experimental: RMC-4630 and sotorasib, Expansion

    Dose Expansion:

    RMC-4630 and sotorasib

    Interventions:
    • Drug: RMC-4630
    • Drug: Sotorasib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 30, 2023)		 47
Original Estimated Enrollment  ICMJE
 (submitted: September 14, 2021)		 46
Estimated Study Completion Date  ICMJE March 3, 2024
Estimated Primary Completion Date September 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject must be ≥18 years of age.
  • Subject must have pathologically documented, locally advanced or metastatic KRASG12C NSCLC (not amenable to curative surgery) that has progressed on prior standard therapies (no more than 3 prior lines of therapies are allowed)

Exclusion Criteria

  • Primary central nervous system (CNS) tumors
  • Known or suspected leptomeningeal or brain metastases or spinal cord compression
  • Clinically significant cardiac disease
  • Known impairment of GI function that would alter the absorption
  • Active autoimmune disease requiring systemic treatment within past 2 years
  • History of severe allergic reactions to any of the study intervention components
  • Major surgical procedures within 28 days or non-study-related minor procedures within 7 days of treatment.
  • Prior therapy with KRASG12C inhibitor and/or SHP2 inhibitor
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   France,   Germany,   Italy,   Korea, Republic of,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05054725
Other Study ID Numbers  ICMJE RMC-4630-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Revolution Medicines, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Revolution Medicines, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Sanofi
  • Amgen
Investigators  ICMJE
Study Director: Revolution Medicines, Inc. Revolution Medicines, Inc.
PRS Account Revolution Medicines, Inc.
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP