Studying Pathways of Resistance in KRAS-driven Cancers

Description

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 Biopsy Assay. Patients who have had resistance mechanisms determined through other assays can also consent to share these data. The Investigator(s) will compare mechanisms of acquired resistance across drugs (e.g. sotorasib vs adagrasib) and between tumor types (e.g. NSCLC vs CRC) to determine if different resistance mutations arise in these settings.

Conditions

KRAS P.G12C

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Study Overview

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Study Details

Study overview

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 Biopsy Assay. Patients who have had resistance mechanisms determined through other assays can also consent to share these data. The Investigator(s) will compare mechanisms of acquired resistance across drugs (e.g. sotorasib vs adagrasib) and between tumor types (e.g. NSCLC vs CRC) to determine if different resistance mutations arise in these settings.

A Non-interventional, Non-treatment, Non-randomized, Single Coordinating Center, Decentralized Bio-specimen Collection Study in USA-based Adult Subjects With Acquired Resistance to KRAS Inhibitors

Studying Pathways of Resistance in KRAS-driven Cancers

Condition
KRAS P.G12C
Intervention / Treatment

-

Contacts and Locations

Boston

Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Cohort 1A- Liquid Biopsy
  • 1. Participants older than 18 years old at the time of consent or age of majority for residential state.
  • 2. Demonstration of having advanced KRAS G12C positive cancer.
  • 3. Systemic progression (not CNS only progression) within the past 30 days, having previously been treated with a therapeutic, targeting the specific KRAS mutation.
  • 4. Patient must not have started a new line of therapy before signing the informed consent form.
  • 5. Willingness to provide a blood specimen prior to the initiation of a new line of treatment.
  • 6. Willingness to provide clinical and medical information to the study team as required.
  • 7. Ability to read, write and communicate in English.
  • 8. Ability to sign a web-based informed consent form.
  • 1. Participants older than 18 years old at the time of consent or age of majority for residential state.
  • 2. Demonstration of having advanced KRAS G12C positive cancer.
  • 3. Systemic progression (not CNS only progression) after being treated with a therapeutic targeting the specific KRAS mutation.
  • 4. Patient must have prior tumor genotyping available (tissue or plasma) after progression on therapeutic targeting the specific KRAS mutation.
  • 5. Willingness to provide clinical and medical information to the study team as required.
  • 6. Ability to read, write and communicate in English.
  • 7. Ability of the participant or legally authorized representative (LAR) to sign a web-based informed consent form.
  • 1. Participants who are unable to comply with the study procedures.
  • 2. Known existence of an uncontrolled intercurrent illness including, but not limited to, psychiatric illness or social situations that would impair compliance with study requirements.
  • 3. Participants who have previously enrolled to the study.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Addario Lung Cancer Medical Institute,

Study Record Dates

2026-06