Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05054725
Ethics application status
Date submitted
14/09/2021
Date registered
23/09/2021

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
UNKNOWN
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05054725