Status:
ACTIVE_NOT_RECRUITING
Studying Pathways of Resistance in KRAS-driven Cancers
Lead Sponsor:
Addario Lung Cancer Medical Institute
Conditions:
KRAS P.G12C
Eligibility:
All Genders
18+ years
Brief Summary
Up to 250 patients from anywhere in the United States can remotely consent and participate to have plasma drawn locally and submitted to Foundation Medicine, Inc. (FMI), for the FoundationOne® Liquid ...
Detailed Description
A hypothesis is that a remote participation plasma NGS study will characterize resistance mechanisms arising in KRAS-mutant cancers among individuals experiencing disease progression while on a KRAS-t...
Eligibility Criteria
Inclusion
- Cohort 1A- Liquid Biopsy
- Participants older than 18 years old at the time of consent or age of majority for residential state.
- Demonstration of having advanced KRAS G12C positive cancer.
- Systemic progression (not CNS only progression) within the past 30 days, having previously been treated with a therapeutic, targeting the specific KRAS mutation.
- Patient must not have started a new line of therapy before signing the informed consent form.
- Willingness to provide a blood specimen prior to the initiation of a new line of treatment.
- Willingness to provide clinical and medical information to the study team as required.
- Ability to read, write and communicate in English.
- Ability to sign a web-based informed consent form.
- Cohort 1B- Data Sharing
- Participants older than 18 years old at the time of consent or age of majority for residential state.
- Demonstration of having advanced KRAS G12C positive cancer.
- Systemic progression (not CNS only progression) after being treated with a therapeutic targeting the specific KRAS mutation.
- Patient must have prior tumor genotyping available (tissue or plasma) after progression on therapeutic targeting the specific KRAS mutation.
- Willingness to provide clinical and medical information to the study team as required.
- Ability to read, write and communicate in English.
- Ability of the participant or legally authorized representative (LAR) to sign a web-based informed consent form.
Exclusion
- Participants who are unable to comply with the study procedures.
- Known existence of an uncontrolled intercurrent illness including, but not limited to, psychiatric illness or social situations that would impair compliance with study requirements.
- Participants who have previously enrolled to the study.
Key Trial Info
Start Date :
September 8 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05272423
Start Date
September 8 2022
End Date
March 1 2026
Last Update
December 18 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215