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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.

Study Description
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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
Non-Small Cell Lung Cancer Drug: RMC-4630 Drug: Sotorasib 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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 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 : December 30, 2021
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : March 3, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Sotorasib

Arms and Interventions
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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 Name: 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 Name: SAR442720

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


Outcome Measures
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Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: approximately 12 months ]
    ORR as assessed per RECIST v1.1


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: approximately 12 months ]
    Number of Participants with Adverse Events

  2. Serious Adverse Events [ Time Frame: approximately 12 months ]
    Number of Participants with Serious Adverse Events

  3. Vital signs [ Time Frame: approximately 12 months ]
    Number of subjects with clinically significant changes in vital signs

  4. Clinical laboratory test values [ Time Frame: approximately 12 months ]
    Number of subjects with clinically significant changes in clinical laboratory test values

  5. ECGs Measurements [ Time Frame: approximately 12 months ]
    Number of subjects with clinically significant changes in ECGs Measurements

  6. Concentration of RMC-4630 [ Time Frame: approximately 12 months ]
    Trough Concentration of RMC-4630

  7. Concentration of sotorasib [ Time Frame: approximately 12 months ]
    Trough Concentration of sotorasib

  8. Duration of response (DOR) [ Time Frame: approximately 12 months ]
    DOR as assessed by RECIST v1.1

  9. Disease Control Rate (DCR) [ Time Frame: approximately 12 months ]
    DCR as assessed by RECIST v1.1

  10. Progression-free survival (PFS) [ Time Frame: approximately 12 months ]
    PFS as assessed by RECIST v1.1

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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05054725


Locations
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Sponsors and Collaborators
Revolution Medicines, Inc.
Sanofi
Amgen
Investigators
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Study Director: Revolution Medicines, Inc. Revolution Medicines, Inc.
More Information
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Responsible Party: Revolution Medicines, Inc.
ClinicalTrials.gov Identifier: NCT05054725    
Other Study ID Numbers: RMC-4630-03
First Posted: September 23, 2021    Key Record Dates
Last Update Posted: April 3, 2023
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Sotorasib
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Antineoplastic Agents