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Non-Small Cell Lung CancerPhase 2NCT05054725

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

A Phase 2 study testing RMC-4630 and Sotorasib in people with Non-Small Cell Lung Cancer, run by Revolution Medicines, Inc. at 60 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
RMC-4630 and Sotorasib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
60 sitesin 10 countries
Study dates
30 Dec 2021to 29 Aug 2024
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

60 sites in 10 countries.

60 sites in 10 countries

United States23 sites

  • University of New Mexico Comprehensive Cancer Center

    Albuquerque, New Mexico, 87131

  • Hematology Oncology Clinic

    Baton Rouge, Louisiana, 70809

  • American Oncology Partners of Maryland, PA

    Bethesda, Maryland, 20817

  • New Jersey Center for Cancer Research

    Brick, New Jersey, 08724

  • Roswell Park cancer Institute

    Buffalo, New York, 14263

  • Charleston Oncology

    Charleston, South Carolina, 29414

  • Tennessee Oncology

    Chattanooga, Tennessee, 37404

  • Maryland Oncology Hematology, P.A.

    Columbia, Maryland, 21044

  • Zangmeister Cancer Center

    Columbus, Ohio, 43219

  • GenHarp Clinical Solutions

    Evergreen Park, Illinois, 60805

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota, 55404

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Clinical Research Alliance, Inc.

    New York, New York, 10021

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

  • BRCR Medical Center Inc.

    Plantation, Florida, 33322

  • Cancer Specialists of North Florida

    Saint Augustine, Florida, 32086

  • New England Cancer Specialists

    Scarborough, Maine, 04074

  • CHRISTUS St. Michael-Colom and Carney Clinic P.A

    Texarkana, Texas, 75503

  • Northwest Cancer specialists, P.C.

    Vancouver, Washington, 98684

Other trials in United States

Germany10 sites

  • Charite Benjamin Franklin Comprehensive Cancer center

    Berlin, 12200

  • Evangelische Lung Clinic

    Berlin, 13125

  • Klinikum Esslingen GmbH

    Esslingen am Neckar, Baden-Wurttemberg, 73730

  • Asklepios Fachkliniken Munchen

    Gauting, Bavaria, 82131

  • Hamato-Onkologie Hamburg

    Hamburg, 20251

  • Lungenklinik Hemer

    Hemer, North Rhine-Westphalia, 58675

  • Comprehensive Cancer Center Mainfranken, University Wuerzburg

    Homburg, Saarland, 66421

  • Lung Cancer Center, University of Saarland

    Homburg, Saarland, 66421

  • POIS Sachsen GmbH

    Leipzig, Saxony, 04347

  • Bethanien Hospital Moers

    Moers, North Rhine-Westphalia, 47441

Other trials in Germany

Spain6 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, Galicia, 15006

  • Hospital Clinic de Barcelona

    Barcelona, Catalonia, 08036

  • Clinica Universidad de Navarra

    Madrid, 28027

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitario Virgen Macarena

    Seville, Andalusia, 41009

  • Hospital Universitario y Politecnico La Fe

    Valencia, 46026

Other trials in Spain

Taiwan5 sites

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 807

  • E-DA Hospital

    Kaohsiung City, 824

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 10002

Other trials in Taiwan

South Korea4 sites

  • Chungbuk National University Hospital

    Cheongju-si, 28644

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Australia3 sites

  • Blacktown Hospital

    Blacktown, 2148

  • Goulburn Valley Health

    Shepparton, 3630

  • South West Oncology

    Warrnambool, Victoria, 3280

Other trials in Australia

Italy3 sites

  • Istituto Europeo Di Oncologia

    Milan, 20141

  • Azienda Ospedaliera dei Colli

    Naples, Campania, 80131

  • Azienda Sanitaria Ospedaliera S Luigi Gonzaga

    Orbassano, Piedmont, 10043

Other trials in Italy

Canada2 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • William Osler Health System

    Mississauga, Ontario, L5N 5M8

Other trials in Canada

France2 sites

  • APHM Hopital Nord, Service d'Oncologie Multidisciplinaire et innovations therapeutics

    Marseille, 13015

  • Hospital Larrey Universite Paul Sabatier

    Toulouse, 31059

Other trials in France

United Kingdom2 sites

  • The Christie NHS Foundation Trust

    Manchester, Greater Manchester, M20 4BX

  • The Royal Marsden NHS Foundation Trust

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

About this study

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

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

Read the 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.

Being tested
RMC-4630, Sotorasib
Keywords
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
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Hereditary Sensory and Autonomic Neuropathies, Carcinoma, Bronchial Neoplasms, Lung Neoplasms, Respiratory Tract Neoplasms, Neoplasms by Site, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RMC-4630Drug

    Also called SAR442720

    RMC-4630 administered orally as a capsule

  • SotorasibDrug

    Also called AMG 510, Lumakras

    Sotorasib administered orally as a tablet

Study groups in NCT05054725
Study groupRoleWhat they receive
RMC-4630 and sotorasib, Safety Run-inExperimentalSafety Run-In: RMC-4630 and sotorasib
Receives: Drug: RMC-4630; Drug: Sotorasib
RMC-4630 and sotorasib, ExpansionExperimentalDose Expansion: RMC-4630 and sotorasib
Receives: Drug: RMC-4630; Drug: Sotorasib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR) as Assessed Per RECIST v1.1

    Evaluation of the antitumor effects of RMC-4630 and sotorasib in locally advanced or metastatic NSCLC patients with KRASG12C mutation with and without co-existing genetic aberrations in specific genes such as STK11/LKB1, KEAP1, and PIK3CA after failure of prior standard therapy. Objective Response Rate (%) is defined as the proportion of patients with Best Overall Response of confirmed CR, or PR. Response was confirmed by a repeat assessment no less than 28 days.

    Measured: 31 months

Secondary outcomes (10)

  1. Clinically Significant Changes in Vital Signs

    Characterization of the safety, tolerability of RMC-4630 in combination with sotorasib for subjects with KRASG12C mutant NSCLC after failure of prior standard therapy

    Measured: 31 months

  2. Clinically Significant Changes in Laboratory Tests

    Characterization of the safety, tolerability of RMC-4630 in combination with sotorasib for subjects with KRASG12C mutant NSCLC after failure of prior standard therapy

    Measured: 31 months

  3. Clinically Significant Changes in ECGs

    Characterization of the safety, tolerability of RMC-4630 in combination with sotorasib for subjects with KRASG12C mutant NSCLC after failure of prior standard therapy

    Measured: 31 months

  4. Trough and Approximate Peak Concentrations of RMC-4630

    Characterization of PK of RMC-4630 in combination with sotorasib for subjects with KRASG12C mutant NSCLC.

    Measured: 31 months

  5. Trough and Approximate Peak Concentrations of Sotorasib

    Characterization of PK of RMC-4630 in combination with Sotorasib for subjects with KRASG12C mutant NSCLC

    Measured: 31 months

  6. Duration of Response (DOR) as Assessed Per RECIST v1.1

    Characterization of efficacy or RMC-4630 in combination with Sotorasib as assessed by DOR, DCR, PFS, and OS in patients with KRAS G12C-mutant locally advanced or metastatic NSCLC after failure of prior standard therapy

    Measured: 31 months

  7. Disease Control Rate (DCR) as Assessed Per RECIST v.1.1

    Characterization of efficacy or RMC-4630 in combination with Sotorasib as assessed by DOR, DCR, PFS, and OS in patients with KRAS G12C-mutant locally advanced or metastatic NSCLC after failure of prior standard therapy

    Measured: 31 months

  8. Progression-free Survival (PFS) as Assessed Per RECIST v1.1

    Characterization of efficacy or RMC-4630 in combination with Sotorasib as assessed by DOR, DCR, PFS, and OS in patients with KRAS G12C-mutant locally advanced or metastatic NSCLC after failure of prior standard therapy

    Measured: 31 months

  9. Overall Survival (OS)

    Characterization of efficacy or RMC-4630 in combination with Sotorasib as assessed by DOR, DCR, PFS, and OS in patients with KRAS G12C-mutant locally advanced or metastatic NSCLC after failure of prior standard therapy

    Measured: 31 months

  10. Incidence, Nature and Severity of TEAEs, SAEs

    Characterization of the safety, tolerability of RMC-4630 in combination with sotorasib for patients with KRASG12C-mutant NSCLC after failure of prior standard therapy. The specifics of the incidence, nature and severity data can be found under the Adverse Events section.

    Measured: 31 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2021
  2. Study start30 Dec 2021
  3. Primary completion3 Jul 2024
  4. Study completion29 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05054725
Sponsor's protocol ID
RMC-4630-03
Status last verified
Dec 2025
First submitted
14 Sep 2021
Last updated
6 Jan 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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