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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05054725




Registration number
NCT05054725
Ethics application status
Date submitted
14/09/2021
Date registered
23/09/2021
Date last updated
3/04/2023

Titles & IDs
Public title
Combination Study of RMC-4630 and Sotorasib for NSCLC Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies
Scientific 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
Secondary ID [1] 0 0
RMC-4630-03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RMC-4630
Treatment: Drugs - Sotorasib

Experimental: RMC-4630 and sotorasib, Safety Run-in - Safety Run-In:
RMC-4630 and sotorasib

Experimental: RMC-4630 and sotorasib, Expansion - Dose Expansion:
RMC-4630 and sotorasib


Treatment: Drugs: RMC-4630
RMC-4630 administered orally as a capsule

Treatment: Drugs: Sotorasib
Sotorasib administered orally as a tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective response rate (ORR)
Timepoint [1] 0 0
approximately 12 months
Secondary outcome [1] 0 0
Adverse Events
Timepoint [1] 0 0
approximately 12 months
Secondary outcome [2] 0 0
Serious Adverse Events
Timepoint [2] 0 0
approximately 12 months
Secondary outcome [3] 0 0
Vital signs
Timepoint [3] 0 0
approximately 12 months
Secondary outcome [4] 0 0
Clinical laboratory test values
Timepoint [4] 0 0
approximately 12 months
Secondary outcome [5] 0 0
ECGs Measurements
Timepoint [5] 0 0
approximately 12 months
Secondary outcome [6] 0 0
Concentration of RMC-4630
Timepoint [6] 0 0
approximately 12 months
Secondary outcome [7] 0 0
Concentration of sotorasib
Timepoint [7] 0 0
approximately 12 months
Secondary outcome [8] 0 0
Duration of response (DOR)
Timepoint [8] 0 0
approximately 12 months
Secondary outcome [9] 0 0
Disease Control Rate (DCR)
Timepoint [9] 0 0
approximately 12 months
Secondary outcome [10] 0 0
Progression-free survival (PFS)
Timepoint [10] 0 0
approximately 12 months
Secondary outcome [11] 0 0
Overall survival (OS)
Timepoint [11] 0 0
approximately 12 months

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
3/03/2024
Actual
Sample size
Target
Accrual to date
Final
47
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
South West Oncology - Warrnambool
Recruitment hospital [2] 0 0
Blacktown Hospital - Blacktown
Recruitment hospital [3] 0 0
Goulburn Valley Health - Shepparton
Recruitment postcode(s) [1] 0 0
3280 - Warrnambool
Recruitment postcode(s) [2] 0 0
2148 - Blacktown
Recruitment postcode(s) [3] 0 0
3630 - Shepparton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Louisiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Maine
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
Nevada
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New Mexico
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
South Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
Canada
State/province [18] 0 0
Alberta
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
France
State/province [20] 0 0
Marseille
Country [21] 0 0
France
State/province [21] 0 0
Toulouse
Country [22] 0 0
Germany
State/province [22] 0 0
Baden-Wurttemberg
Country [23] 0 0
Germany
State/province [23] 0 0
Bavaria
Country [24] 0 0
Germany
State/province [24] 0 0
North Rhine- Westphalia
Country [25] 0 0
Germany
State/province [25] 0 0
North Rhine-Westphalia
Country [26] 0 0
Germany
State/province [26] 0 0
Saarland
Country [27] 0 0
Germany
State/province [27] 0 0
Sachsen
Country [28] 0 0
Germany
State/province [28] 0 0
Berlin
Country [29] 0 0
Germany
State/province [29] 0 0
Hamburg
Country [30] 0 0
Italy
State/province [30] 0 0
Campania
Country [31] 0 0
Italy
State/province [31] 0 0
Piedmont
Country [32] 0 0
Italy
State/province [32] 0 0
Milano
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Cheongju-si
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Seoul
Country [35] 0 0
Spain
State/province [35] 0 0
Andalucia
Country [36] 0 0
Spain
State/province [36] 0 0
Catalonia
Country [37] 0 0
Spain
State/province [37] 0 0
Galicia
Country [38] 0 0
Spain
State/province [38] 0 0
Navarra
Country [39] 0 0
Spain
State/province [39] 0 0
Madrid
Country [40] 0 0
Spain
State/province [40] 0 0
Valencia
Country [41] 0 0
Taiwan
State/province [41] 0 0
Kaohsiung
Country [42] 0 0
Taiwan
State/province [42] 0 0
Taichung
Country [43] 0 0
Taiwan
State/province [43] 0 0
Tainan
Country [44] 0 0
Taiwan
State/province [44] 0 0
Taipei
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Greater Manchester
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Revolution Medicines, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Sanofi
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Amgen
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the antitumor effects of sotorasib and RMC-4630 in
subjects with KRASG12C mutant NSCLC
Trial website
https://clinicaltrials.gov/ct2/show/NCT05054725
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Revolution Medicines, Inc.
Address 0 0
Revolution Medicines, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries