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

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05054725
• Other study ID #: RMC-4630-03
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 30, 2021
• Est. completion date: March 3, 2024

Study information

• Verified date: October 2022
• Source: Revolution Medicines, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 47
• Est. completion date: March 3, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• RMC-4630
RMC-4630 administered orally as a capsule
• Sotorasib
Sotorasib administered orally as a tablet

Locations

Country	Name	City	State
Australia	Blacktown Hospital	Blacktown
Australia	Goulburn Valley Health	Shepparton
Australia	South West Oncology	Warrnambool	Victoria
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	William Osler Health System	Mississauga	Ontario
France	APHM Hopital Nord, Service d'Oncologie Multidisciplinaire et innovations therapeutics	Marseille
France	Hospital Larrey Universite Paul Sabatier	Toulouse
Germany	Charite Benjamin Franklin Comprehensive Cancer center	Berlin
Germany	Evangelische Lung Clinic	Berlin
Germany	Klinikum Esslingen GmbH	Esslingen	Baden-Wurttemberg
Germany	Asklepios Fachkliniken Munchen	Gauting	Bavaria
Germany	Hamato-Onkologie Hamburg	Hamburg
Germany	Lungenklinik Hemer	Hemer	North Rhine- Westphalia
Germany	Comprehensive Cancer Center Mainfranken, University Wuerzburg	Homburg	Saarland
Germany	Lung Cancer Center, University of Saarland	Homburg	Saarland
Germany	POIS Sachsen GmbH	Leipzig	Sachsen
Germany	Bethanien Hospital Moers	Moers	North Rhine-Westphalia
Italy	Istituto Europeo Di Oncologia	Milano
Italy	Azienda Ospedaliera dei Colli	Napoli	Campania
Italy	Azienda Sanitaria Ospedaliera S Luigi Gonzaga	Orbassano	Piedmont
Korea, Republic of	Chungbuk National University Hospital	Cheongju-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Spain	Complejo Hospitalario Universitario A Coruña	A Coruña	Galicia
Spain	Hospital Clinic de Barcelona	Barcelona	Catalonia
Spain	Clinica Universidad de Navarra	Madrid
Spain	Clinica Universidad de Navarra	Pamplona	Navarra
Spain	Hospital Universitario Virgen Macarena	Sevilla	Andalucia
Spain	Hospital Universitario y Politecnico La Fe	Valencia
Taiwan	E-DA Hospital	Kaohsiung
Taiwan	Kaohsiung Medical University Chung Ho Memorial Hospital	Kaohsiung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei
United Kingdom	The Christie NHS Foundation Trust	Manchester	Greater Manchester
United Kingdom	The Royal Marsden NHS Foundation Trust	Sutton	Surrey
United States	University of New Mexico Comprehensive Cancer Center	Albuquerque	New Mexico
United States	Hematology Oncology Clinic	Baton Rouge	Louisiana
United States	American Oncology Partners of Maryland, PA	Bethesda	Maryland
United States	New Jersey Center for Cancer Research	Brick	New Jersey
United States	Roswell Park cancer Institute	Buffalo	New York
United States	Charleston Oncology	Charleston	South Carolina
United States	Tennessee Oncology	Chattanooga	Tennessee
United States	Maryland Oncology Hematology, P.A.	Columbia	Maryland
United States	Zangmeister Cancer Center	Columbus	Ohio
United States	GenHarp Clinical Solutions	Evergreen Park	Illinois
United States	Virginia Cancer Specialists	Fairfax	Virginia
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Minnesota Oncology Hematology, P.A.	Minneapolis	Minnesota
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Clinical Research Alliance, Inc.	New York	New York
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	Nebraska Cancer Specialists	Omaha	Nebraska
United States	BRCR Medical Center Inc.	Plantation	Florida
United States	Cancer Specialists of North Florida	Saint Augustine	Florida
United States	New England Cancer Specialists	Scarborough	Maine
United States	CHRISTUS St. Michael-Colom and Carney Clinic P.A	Texarkana	Texas
United States	Northwest Cancer specialists, P.C.	Vancouver	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Revolution Medicines, Inc.	Amgen, Sanofi

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Italy,  Korea, Republic of,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	ORR as assessed per RECIST v1.1	approximately 12 months
Secondary	Adverse Events	Number of Participants with Adverse Events	approximately 12 months
Secondary	Serious Adverse Events	Number of Participants with Serious Adverse Events	approximately 12 months
Secondary	Vital signs	Number of subjects with clinically significant changes in vital signs	approximately 12 months
Secondary	Clinical laboratory test values	Number of subjects with clinically significant changes in clinical laboratory test values	approximately 12 months
Secondary	ECGs Measurements	Number of subjects with clinically significant changes in ECGs Measurements	approximately 12 months
Secondary	Concentration of RMC-4630	Trough Concentration of RMC-4630	approximately 12 months
Secondary	Concentration of sotorasib	Trough Concentration of sotorasib	approximately 12 months
Secondary	Duration of response (DOR)	DOR as assessed by RECIST v1.1	approximately 12 months
Secondary	Disease Control Rate (DCR)	DCR as assessed by RECIST v1.1	approximately 12 months
Secondary	Progression-free survival (PFS)	PFS as assessed by RECIST v1.1	approximately 12 months
Secondary	Overall survival (OS)	Overall survival (OS)	approximately 12 months