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Combination Study of RMC-4630 and Sotorasib for NSCLC Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies

Sponsor
Revolution Medicines, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05054725
Collaborator
Sanofi (Industry), Amgen (Industry)
46
Enrollment
39
Locations
2
Arms
24.6
Anticipated Duration (Months)
1.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the antitumor effects of sotorasib and RMC-4630 in subjects with KRASG12C mutant NSCLC

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
46 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Dec 30, 2021
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Jan 19, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: RMC-4630 and sotorasib, Safety Run-in

Safety Run-In: RMC-4630 and sotorasib

Drug: RMC-4630
RMC-4630 administered orally as a capsule
Other Names:
  • SAR442720

    • Drug: Sotorasib
    Sotorasib administered orally as a tablet
    Other Names:
  • AMG 510
  • Lumakras

    		•
    Experimental: RMC-4630 and sotorasib, Expansion

    Dose Expansion: RMC-4630 and sotorasib

    Drug: RMC-4630
    RMC-4630 administered orally as a capsule
    Other Names:
  • SAR442720

    • Drug: Sotorasib
    Sotorasib administered orally as a tablet
    Other Names:
  • AMG 510
  • Lumakras

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective response rate (ORR) [approximately 12 months]

      ORR as assessed per RECIST v1.1

    Secondary Outcome Measures

    1. Adverse Events [approximately 12 months]

      Number of Participants with Adverse Events

    2. Serious Adverse Events [approximately 12 months]

      Number of Participants with Serious Adverse Events

    3. Vital signs [approximately 12 months]

      Number of subjects with clinically significant changes in vital signs

    4. Clinical laboratory test values [approximately 12 months]

      Number of subjects with clinically significant changes in clinical laboratory test values

    5. ECGs Measurements [approximately 12 months]

      Number of subjects with clinically significant changes in ECGs Measurements

    6. Concentration of RMC-4630 [approximately 12 months]

      Trough Concentration of RMC-4630

    7. Concentration of sotorasib [approximately 12 months]

      Trough Concentration of sotorasib

    8. Duration of response (DOR) [approximately 12 months]

      DOR as assessed by RECIST v1.1

    9. Disease Control Rate (DCR) [approximately 12 months]

      DCR as assessed by RECIST v1.1

    10. Progression-free survival (PFS) [approximately 12 months]

      PFS as assessed by RECIST v1.1

    11. Overall survival (OS) [approximately 12 months]

      Overall survival (OS)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Florida Cancer Specialists Fort Myers Florida United States 33901
    2 BRCR Medical Center Inc. Plantation Florida United States 33322
    3 Cancer Specialists of North Florida Saint Augustine Florida United States 32086
    4 GenHarp Clinical Solutions Evergreen Park Illinois United States 60805
    5 Hematology Oncology Clinic Baton Rouge Louisiana United States 70809
    6 New England Cancer Specialists Scarborough Maine United States 04074
    7 Minnesota Oncology Hematology, P.A. Minneapolis Minnesota United States 55404
    8 Nebraska Cancer Specialists Omaha Nebraska United States 68130
    9 Comprehensive Cancer Centers of Nevada Las Vegas Nevada United States 89169
    10 New Jersey Center for Cancer Research Brick New Jersey United States 08724
    11 Roswell Park cancer Institute Buffalo New York United States 14263
    12 Clinical Research Alliance, Inc. New York New York United States 10021
    13 Zangmeister Cancer Center Columbus Ohio United States 43219
    14 Charleston Oncology Charleston South Carolina United States 29414
    15 Tennessee Oncology Chattanooga Tennessee United States 37404
    16 Sarah Cannon Research Institute Nashville Tennessee United States 37203
    17 CHRISTUS St. Michael-Colom and Carney Clinic P.A Texarkana Texas United States 75503
    18 Virginia Cancer Specialists Fairfax Virginia United States 22031
    19 Virginia Oncology Associates Norfolk Virginia United States 23502
    20 Northwest Cancer specialists, P.C. Vancouver Washington United States 98684
    21 South West Oncology Warrnambool Victoria Australia 3280
    22 Blacktown Hospital Blacktown Australia 2148
    23 Goulburn Valley Health Shepparton Australia 3630
    24 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2
    25 Klinikum Esslingen GmbH Esslingen Baden-Wurttemberg Germany 73730
    26 Asklepios Fachkliniken Munchen Gauting Bavaria Germany 82131
    27 Lungenklinik Hemer Hemer North Rhine- Westphalia Germany 58675
    28 POIS Sachsen GmbH Leipzig Sachsen Germany 04347
    29 Charite Benjamin Franklin Comprehensive Cancer center Berlin Germany 12200
    30 Azienda Ospedaliera dei Colli Napoli Campania Italy 80131
    31 Azienda Sanitaria Ospedaliera S Luigi Gonzaga Orbassano Piedmont Italy 10043
    32 Chungbuk National University Hospital Cheongju-si Korea, Republic of 28644
    33 Seoul National University Hospital Seoul Korea, Republic of 03080
    34 Asan Medical Center Seoul Korea, Republic of 05505
    35 Samsung Medical Center Seoul Korea, Republic of 06351
    36 Kaohsiung Medical University Chung Ho Memorial Hospital Kaohsiung Taiwan 807
    37 E-DA Hospital Kaohsiung Taiwan 824
    38 National Cheng Kung University Hospital Tainan Taiwan 704
    39 National Taiwan University Hospital Taipei Taiwan 10002

    Sponsors and Collaborators

    • Revolution Medicines, Inc.
    • Sanofi
    • Amgen

    Investigators

    • Study Director: Revolution Medicines, Inc., Revolution Medicines, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Revolution Medicines, Inc.
    ClinicalTrials.gov Identifier:
    NCT05054725
    Other Study ID Numbers:
    • RMC-4630-03
    First Posted:
    Sep 23, 2021
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Revolution Medicines, Inc.
    SHP2
    NSCLC
    KRAS G12C
    BRAF Class 1/2/unclassified
    KRAS amplification
    KRAS mutation
    STK11/LKB1
    KEAP1
    PIK3CA
    ATRX
    BRCA2
    carcinoma, non-small lung cancer
    bronchial neoplasms
    lung neoplasms
    respiratory tract neoplasms
    neoplasms by site
    neoplasms
    lung diseases
    respiratory tract diseases
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Aug 19, 2022